So you can be more knowledgeable, and so you can talk to us more accurately about your drug naming needs, we've listed many common terms––and some uncommon––in this one-of-a-kind glossary. It's packed with indispensible drug-naming definitions, plus fun anecdotes and tips. Whether you're new to drug naming or just need to brush up on terminology, this glossary will help. Do you know the "train wreck scenario" in drug naming? What is a semordnilap drug name? How can a drug name fail the misbranding review?

And since language is always evolving, the Drug Naming Glossary will change too with your help. Enjoy this resource, and if we missed any terms, or if you have comments, please let us know here!

Acronym

An abbreviation pronounced as a word (usually) formed from the initial letters of a group of words or a phrase. Acronyms can shorten an otherwise long phrase or title, making it easier to say and remember. That may account for why drug classifications are often referred to by their acronym. ACE (Angiotensin-Converting Enzyme) inhibitors are a long-standing example. USAN is an acronym for United States Adopted Name. The ACCORD (Action to Control CardiOvascular Risk in Diabetes) clinical trial name is another example. Because acronyms simplify and condense communication, incorporating them into brand names has been an effective drug-naming tactic. For example, Adcetris® and Kadcyla® are both ADCs (Antibody-Drug Conjugates). Also see Drug Nomenclature.

Action Date

The date when a drug compound receives its final approval decision from FDA. Sponsor Pharma companies seek to have a secured, safely vetted drug name well before their action date. Also see PDUFA and Train Wreck Scenario.

Alphanumeric Name

Alphanumeric brand names contain letters and numbers, such as 7Up®, 3M®, and V8®. In Pharma, alphanumeric brand names, like the OTC brand Effidac 24®, are frowned upon because they can be misleading (does it mean 24 tablets, 24 mg, 24 days, etc.) and prone to medication error. There are exceptions to this rule, handled on a case-by-case basis.

Anagram

From Greek meaning "writing back or anew," an anagram is a word, phrase, or name formed by rearranging all the letters of another word, usually in a playful manner. For instance, the car brand CAMRY is an anagram for "my car." The next time you see “Election Results” think of the rally call, “Lies – Let’s recount.”

We are not aware of any anagrams in Pharma naming, however, Dimoxinil is the fictional brand name of a hair growth drug in the American animated sitcom, The Simpsons. Dimoxinil is an anagram of minoxidil, a drug that is actually used for treatment of male pattern baldness. In 1988 minoxidil was approved for treating baldness in men with the brand name Rogaine® (famously, FDA rejected Upjohn's first name choice, Regaine, due to misbranding). Minoxidil is also sold as Loniten®, a tablet for treating high blood pressure. Rogaine and Loniten are dual trademarks for the same active ingredient marketed by the same company.

Arbitrary Name

An arbitrary brand name is a common word with a dictionary definition that bears no obvious, direct relationship to that which it describes but is used in a meaningless context. Apple® Computer is often pointed out as an arbitrary name. In Pharma, examples of arbitrary names are Allegra® and Sonata®.

Biologics License Application (BLA)

In the USA, FDA approves biologic products for marketing. A BLA, containing specific product information, is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce. Sponsors usually complete drug nomenclature development well before this stage. Also see NDA.

Biosimilar

The term biosimilar refers to biologic products that are marketed after expiration of patents, which are claimed to have similar properties to existing biologic products. Omnitrope® (somatropin) was the first biosimilar product approved in the EU in 2006. A recent approval in the EU for Biogen’s Flixabi (infliximab) is another example. The first biosimilar product approved in the United States was Zarxio® (filgrastim-sndz) in 2015. As can be seen with these products, the nonproprietary naming scheme for biosimilars is dissimilar. It is currently under review by FDA, and WHO has issued suggested guidelines that have not been finalized.

Blank Slate Name

See Coined Name.

Blockbuster Drug

A blockbuster drug in Pharma (also "megabrand") is a drug generating more than $1 billion of revenue annually. According to AstraZeneca, a megabrand is a product that:

Reaches $1 billion in annual sales by year two of launch and is clearly destined to achieve peak sales of several billion dollars
Requires a rapid global roll-out to around 60 countries within that two-year period
Needs a huge marketing investment.

Tagamet® was the first drug to achieve this status. Considering there are scores of blockbuster drugs today, there is little wonder why the current big-Pharma business model is built on these drugs. Some new terms include super blockbusters (drugs that have sold more than $2 billion each annually), and mega blockbusters (drugs that have sold more than $10 billion in sales per year). The best selling drugs in the world today include Humira®, Sovaldi®, and Enbrel®.

Brand Archetype

Brand archetypes, based on Jungian archetypes, are concepts or models of common patterns of human life that are assigned to a brand for suggesting the driving force or motivation behind the brand. Brand archetypes include the pioneer, the wizard, the scientist, the sage and the artist. With the brand personality, the brand archetype helps give a brand a more powerful, human, and iconic brand story.

Brand Architecture

The structure of brands in an organization, and most importantly, the relationship of each brand to one another. Most brands fit into these descriptive brand architecture levels:

Masterbrand (or "monolithic" brand) model where all share the same dominant, parent brand, such as FedEx
Endorsed brand model, which is comprised of individual brands and sub-brands linked by an endorsing parent brand, like Nabisco
Freestanding (or "house of brands") model, where separate brands are independent and dominant of the corporate brand, as demonstrated by Procter & Gamble.

The freestanding model is the model of choice for most if not all Pharma companies. It fits well with companies that have distinct brands for different audiences supported with separate budgets, like Pfizer for example. Another reason why Pharma favors the Freestanding model is because the corporate brand is assigned a lower profile and is not always directly associated with its individual brands and pipeline assets. This is an advantage should one of the assets be assoicated with negative event such as a patient fatality.

Brand Essence

Brand essence is a statement of the “heart and soul” of a brand, expressed as succinctly and as vividly as possible. For example, the Disney® brand essence is "fun family entertainment." Viagra® brand essence is said to be "performance" and Lyrica® is "to calm." The process of developing brand essence takes into account the target audience, the brand benefits and reasons to believe, and the brand character.

Brand Identity

Brand identity is the commercial expression of the brand in terms of its verbal (i.e. name) and visual (i.e. logo) impression. The brand’s identity should reflect its brand essence and demonstrate differentiation from competitors.

Breakaway Consonant

A "breakaway consonant" is a brand naming construction consisting of a single consonant letter, usually at the beginning of a name, followed by a morpheme with an initial consonant letter, forcing the first consonant letter to be pronounced as an independent syllable. It is a brand-naming device that adds distinctiveness. Examples include the drug names Vfend®, Qsymia®, Qvar®, Nplate®, Xgeva®, and ZMapp®.

Brief

Key information given to the naming firm detailing the client’s reasons for requiring a drug name and its significant parameters, such as information needs/objectives, geographies to be covered, target professionals, timing, and so on.

Center For Drug Evaluation and Research (CDER)

CDER evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of the drugs. CDER also works with drug companies to reduce medication errors related to confusing labels, labeling, drug packaging, and drug names that look alike or sound alike. For CDER-regulated products, the Division of Medication Error Prevention and Analysis (DMEPA) is primarily responsible for the premarket review of proposed proprietary names, labels/labeling, packaging, and Human Factor Studies in order to reduce the potential for medication errors. Also see DMEPA.

Centralised Procedure (in EU)

A pan-EU authorization of a medicine, valid for all EU member states. The centralised procedure, which came into operation in 1995, allows applicants to obtain a marketing authorization that is valid throughout the EU. It is compulsory for medicinal products manufactured using biotechnological processes, for orphan medicinal products and for human products containing a new active substance which was not authorized in the Community before 20 May 2004 and which are intended for the treatment of AIDS, cancer, neurodegenerative disorder or diabetes. The centralised procedure is also mandatory for veterinary medicinal products intended primarily for use as performance enhancers in order to promote growth of treated animals or to increase yields from treated animals. There also needs to be one identical brand name in all the member states, which means that a single objector member state can foil the single brand name procedure. Also see EU, Name Review Group.

Chemical Name

See Drug Nomenclature.

Classification of Goods & Services

Goods and services are classified by an internationally recognized trademark system consisting of 45 classes. Class 5 is Pharmaceuticals.

Drug names are filed in Class 5, and usually Class 10 (Medical Apparatus) too. Also see USPTO.

Clinical Trial Name / Branding

Clinical trial branding is the strategy of creating the verbal and visual identity for a single clinical trial or a set of clinical trials under a program. The various styles of clinical trial naming include:

Acronyms (or semi-acronyms)––such as the TORPEDO trial (for Thrombus Obliteration by Rapid Percutaneous Endovenous Intervention in Deep Venous Occlusion)
Proprietary names––such as the TOviTO® Program (The extensive TOviTO® clinical trial program for tiotropium + olodaterol also encompasses studies in the program named DYNAGITO®, TONADO®, VIVACITO®, and TORRACTO®)
Relevant terms or messages––such as the NeoSphere® trial (the NeoSphere name highlights the neoadjuvant treatment evaluated in HER2+ breast cancer regarding pertuzumab clinical trials--trade name: Perjeta®)

Establishing a clinical trial brand is an effective way to build awareness for clinical trials given trial enrollment globally has become extremely competitive. There are literally tens of thousands of trials seeking similar patient populations. In addition, the healthcare industry faces many challenges in conducting communication and branding due to limitations imposed by regulatory authorities. Sponsor companies are prohibited from over promoting an investigational product as safe or effective. Therefore, the best-practices process for developing clinical trial brands and for selecting names usually includes strategy, name creation, and various in-depth screenings of clinical trial registers, legal availability, regulatory and name safety, and internet searches.

Code Name

See Drug Nomenclature.

Coined Name

A coined name is an invented name that does not show or express any obvious, immediate meaning. Common in drug naming, coined names can avoid misleading associations, which is prohibited. Best coined-name example: Viagra®. Synonym: Blank Slate Name.

Committee for Medicinal Products for Human Use (CHMP)

At the European Medicines Agency, the Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing opinions on questions concerning medicines for human use. CHMP established the Name Review Group (NRG) to review drug names. CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP).

Common Name

See Drug Nomenclature.

Complete Response Letter

Taking the place of 'approvable' and 'not approvable' letters in the USA, a 'complete response' letter is issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. Also see Action Date.

Concept Statement

Usually a written presentation of a new product concept, in terms of its function, benefits, design, branding, etc.

Conjoint Analysis

Conjoint analysis is a family of statistical, quantitative techniques that measure the relative importance or preference individuals attach to particular product attributes (described in terms of which features they would trade off for others). A good tool for determining the priority of brand messages.

Debranding

The removal of brand names, packaging or other material that would enable participants in market research studies to identify the drug or brand being studied. In most naming studies, debranding is employed in order to obtain clean, unbiased research information.

Descriptive Name

These types of names tell of an ingredient, quality, characteristic, function, feature, purpose or use of the specified goods or services. Pharma naming examples include Lipitor®, Herceptin®, and Tracleer®.

Descriptor

See Modifier.

Desk Research

The systematic examination of all available secondary data in the context of a particular branding, naming, or marketing research project.

Differentiation

Differentiation is what a brand or a company can stand for that no other competitor can to help create preference and an overall competitive advantage. Differentiation in drug naming is the goal. Also see Drug Nomenclature.

Direct-To-Consumer (DTC) Advertising

This generally refers to the marketing of pharmaceuticals directly to patients and the consuming public over healthcare professionals. The obvious forms include TV, radio, print and other mass and social media vehicles. Banned in Europe and most Western nations, DTC advertising is permitted in only three nations: USA, New Zealand, and Brazil. In 2014, ad spending in the USA jumped to $4.5 billion, and the top 5 spending brands (according to Kantar Media) were Cialis® ($272 million), Humira® ($259 million), Lyrica® ($246 million), Viagra® ($232 million) and Eliquis® ($221 million).

Division of Medication Error Prevention and Analysis (DMEPA)

The FDA Division of Medication Error Prevention and Analysis (DMEPA) is responsible for reviewing drug proprietary names, labeling, packaging, and product design prior to drug approval to help prevent medication errors. DMEPA reviews proposed drug names for the following:

Confusing similarity or look or sound alike to the names of other drugs, drug ingredients, and established or generic names.
Drug names that include medical and/or coined abbreviations, inactive ingredients or the United States Adopted Name (“USAN”) stem, and names that are the same as that of a discontinued product
Drug names that include product attributes such as dosage form (tabs), route of administration (oral), manufacturing characteristics (lyophilized), dosing interval (BID) and name modifiers
Drug names that potentially exaggerate, lead to erroneous prescriptions
Drug names that are potentially "misleading" due to suggesting undue claims, implying unique effectiveness or maximum strength

Over one-third of all names are rejected, although since FDA released draft guidance on best practices for developing pharmaceutical trademarks in 2014, FDA acceptance is rising. DMEPA also provides guidance to industry on drug development considerations from a medication errors perspective. Also see Misbranding Review, POCA, NSS.

Drug Class Name

A drug class name is a name for a group of drugs that have similar characteristics. All drugs are placed in either one or more drug class or sub-class.

Drugs in the same class share a common recognizable nonproprietary name "stem," or standardized syllables that relate drugs to existing drug classes or families. For example, celecoxib (Celebrex®), rofecoxib (Vioxx®) and valdecoxib (Bextra®) all share the -coxib suffix stem that identifies them as being in the same drug class, the Cox-2 Inhibitor drugs.

Three conditions determine how drugs are classified:

The drugs are related by their chemical structure. Aspirin is a salicylate. Its full chemical name is “acetylsalicylic acid” (or ASA).
The drugs work in the same way. Aspirin can prevent the formation of blood clots by stopping molecules in the blood called platelets from clumping or aggregating. So it belongs to a drug class called "anti-platelets" or "platelet aggregation inhibitors." Plavix® (clopidogrel bisulfate) is also an anti-platelet drug.
The drugs are used for the same purpose. Aspirin is used to reduce fever. Drugs that treat fever are called "anti-pyretic drugs" or "anti-pyretics." Advil® (ibuprofen) is an anti-pyretic drug too.

Drug class names and drug sub-class names (also labeled "segment identifiers") are specific and meaningful terms or acronyms that help classify and better define (or separate) a drug vis-à-vis similar drugs and drug classifications. For instance, consider these drugs in the erythropoiesis-stimulating agents (ESA) class: Aranesp®, Epogen®, Mircera®, and Omontys® (now discontinued). Beyond their ESA drug classification, new drug sub-class names appeared to help better identify and differentiate each brand in meaningful therapeutic ways:

Epogen was the hailed as the first ESA (erythropoiesis-stimulating agent);
Aranesp followed and was cited in early literature during its clinical development as a NESP (for novel erythropoiesis-stimulating protein);
Mircera, another drug that differs from other ESAs in that it is a CERA (for continuous erythropoiesis receptor activator);
Omontys, the most recent entry in the class, is a unique synthetic peptide-based ESA that stimulates the production of red blood cells in the body.

This variety of nomenclature demonstrates how sponsor companies can be enterprising with drug class naming. Since no stated guidance on drug class naming exists apart from the rules governing USAN, INN and the USP, acceptance by the professional community (KOLs), plus uptake from the press and relevant influencers are the measures for adoption of new drug class or drug sub-class names.

Drug Development Cost

According to an analysis by the Tufts Center for the Study of Drug Development in 2014, the capitalized cost to develop a new drug is about $1.4 billion (USD) over 8-10 years. Considering only 1 in 5 drugs that start Phase I trials are eventually approved for marketing, the main reason (among many variables) for the expense is failure. In comparison, the fees for creating drug nomenclature for those assets that survive are a fraction of the drug development costs.

Drug Nomenclature

Drug nomenclature is the broad, complex and sometimes whimsical body of names used for drugs, groups of drugs, and studies of drugs throughout the pharmaceutical world. With the possible exception of the chemical name, sponsor companies can and should take charge of managing their own drug nomenclature. There are several drug nomenclature opportunities listed below where this is possible. The most well known types of drug nomenclature are created systematically and sequentially as a drug moves from the bench to the bedside. They are:

Chemical Names––The chemical name is established by IUPAC (International Union of Pure and Applied Chemistry) based on the atomic or molecular structure of the drug. The name is long, complex and not for general use. For example, the chemical name for Viagra® is "5-[2-ethoxy-5-(4-methylpiperazin-1-ylsulfonyl)phenyl]-1- methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one, formula C22H30N6O4S." Chemical names are assigned before clinical trial testing begins.
Nonproprietary Names (also called "scientific names," "established names" and "generic names")––The nonproprietary name is the "shorter" name assigned to a chemical or active ingredient. It is recognized or recommended by regulatory agencies for general public use and is not subject to trademark (proprietary) rights. Every drug has a unique nonproprietary name, however, part of the name, called a "stem," is shared with other drugs of the same drug class. An example of a nonproprietary name is pertuzumab (trademark Perjeta®) for treating breast cancer. Companies create nonproprietary names and apply to organizations like INN and USAN for assignment of their name. Many Pharma companies start developing nonproprietary names in Phase I or in early Phase II (in the USA, after obtaining an Investigational New Drug).
Drug Class Names (also called "segment Identifiers")––A drug class name is a name for a group of drugs that have similar characteristics. All drugs are placed in either one or more drug classes, and recognized by a shared "stem," or standardized syllables that relate drugs to existing drug classes or families. (Also see Drug Class Name above.)
Proprietary Names (also called the brand name, trade name, or trademark)--The proprietary name is a registered trademark and not usable by others without permission. The proprietary name is the first commercial impression of the brand. Companies start thinking about creating proprietary names in Phase II or at their “proof of concept” point. Examples of proprietary names are Perjeta® and Spiolto®.

Other types of drug nomenclature less well known and not officially sanctioned by governing bodies, but in common use, include:

Clinical Trial Names––The strategy of creating the verbal identity (and often a visual identity) for a single clinical trial or a set of clinical trials under a program is a common practice. Usually acronyms, clinical trial names are an effective way to build awareness given trial enrollment has become extremely competitive globally. Examples include the ACCORD trial (for Action To Control Cardiovascular Risk In Diabetes) and TOviTO®.
Code Names––Sponsor companies often give a "code name" by their drugs in the early development stages to identify the asset as theirs. The company code name usually identifies the drug with a prefix and a number. For example, "SB4" was the code name for Benepali®, where /SB/ is for Samsung Bioepis (a joint venture between Samsung BioLogics and Biogen) and /4/ is a reference to one of their biosimilar products. Many sponsor companies stick to this naming architecture when stamping their company code on a developing drug. Hence, the R&D pipeline assets for Amgen are coded as AMG 211, AMG 224, etc.; for Merck, MK-7622, MK-1029, etc.; for Pfizer, PF-04950615, PF-04971729; and so on. Company code names are transient, and usually replaced by the nonproprietary name when it is established.
"Pet" Names––Not to be confused with veterinary medicine, a "pet" name for a drug is a familiar or humorous name usually made up and used by the sponsor company employees instead of or as well as using the drug's real name. Drug "pet" names can be shorthand versions of drug nomenclature, sort of like a drug "nickname." For example, while under development the drug tobramycin, an inhaled antibiotic, was known inside PathoGenesis Corporation as "Tobi" well before the drug name was trademarked.
Trivial Names (also called "common name" and sometimes generic name)--A trivial name is a name or acronym of a chemical or drug that gives little or no indication as to chemical structure, usually because it is developed unsystematically and used by the general public. Trivial names are often shortenings of long systematic names. Examples are aspirin (for acetylsalicylic acid), baking soda (sodium bicarbonate) and DDT (dichlorodiphenyltrichloroethane).

Drug nomenclature, when not officially recognized or presided over, can take on a life of its own, and many times in ways contrary to sponsors' intentions.

"RU486," for example, was the company code name (from the 38,486th compound synthesized by Roussel-Uclaf) for mifepristone (trade name Mifeprex®), an abortion pill. But "RU486" soon became a pun known on the street as "are you for getting rid of something?" Not the messaging the sponsor company intended.
Another example is "AZT." Many more people have heard of the trivial name "AZT" (azidothymidine, the first drug licensed to treat HIV infection by FDA in 1987) than its proprietary name, Retrovir®, making Retrovir one of the least recognized drug trademarks ever (Google each name and see).

Dual Trademarks (from the same company for two products with the same active ingredient)

There are several examples of dual trademarks by the same manufacturer for two products with the same active ingredient on the market today. Regulators, however, have discouraged their use due to the potential for "double dosing" and other mix-ups, except when a stigma exists to discourage an important new use of an existing drug, or when a unique dispensing condition exists. For example, denosumab is the nonproprietary name for Prolia® and Xgeva® (from Amgen). Two distinct trade names were assigned in order to differentiate between their unique dosing schedules and indications for use. Other examples include: triamcinolone (Nasacort® (allergies) and Azmacort® (asthma)); fluoxetine (Prozac® (anti-depressant) and Sarafem® (pre- menstrual dysforic disorder)); budesonide (Pulmicort® (asthma) and Entocort® and Rhinocort® (allergy)); bupropion (Wellbutrin® (depression) and Zyban® (smoking cessation)); finasteride (Propecia® (male pattern baldness) and Proscar® (benign prostatic hyperplasia)); tazarotene (Tazorac® (acne) and Avage® (facial wrinkling)); sildenafil (Viagra® (erectile dysfunction) and Revatio® (pulmonary arterial hypertension)); minoxidil (Rogaine® (male pattern baldness) and Loniten® (high blood pressure)).

Established Name

See Drug Nomenclature.

European Medicines Agency (EMA)

The European Medicines Agency is a decentralized agency of the European Union, located in London (prior to Brexit). The Agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995. Also see Centralized Procedure and EU.

European Pharmaceutical Marketing Research Association (EphMrA)

The major European Pharmaceutical Marketing Research Association.

European Union (EU)

A unique political and economic partnership of 27 member states (28 prior to Brexit) primarily located in Europe. The EU countries are: Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden (the UK voted to exit the EU as of June 2016). Biopharma companies consider this a major territory for trademark registration and marketing authorization. Also see Centralized Procedure (in EU).

Failure Mode and Effects Analysis (FMEA)

In assessing drug names for safety, FMEA is a systematic prospective method (used by drug safety firms and regulatory authorities) that examines the nomenclature of a product for possible ways in which a failure (i.e., an error) can occur once a comprehensive list of potentially similar names is developed. To identify potential failure modes, the proposed proprietary name is compared to all of the names gathered during the safety review. Because product name confusion can occur at any point in the medication use process, the potential for confusion throughout the entire medication use process, including product procurement, prescribing/ordering, dispensing, administration, and monitoring the effects of a medication, are considered. If the FMEA determines that the proposed proprietary name could be a source of confusion that could cause medication errors under the proposed prescribing conditions, the proposed proprietary name is found unacceptable. Also see Name Safety Review.

Family Branding

See Umbrella Branding.

Fanciful Name

Fanciful names, from a trademark perspective, are considered invented without any recognizable semantic meaning. Exxon is often pointed to as a fanciful, inherently distinctive trademark. This is not to be confused with a "fanciful name" from the pharmaceutical regulatory perspective. Pharma regulatory authorities apply a dictionary definition of "over imaginative and unrealistic." Therefore, "a fanciful proprietary name" that states or implies a quality of the drug, such as BestMed or DrugSuper; or otherwise implies unique effectiveness, overstates efficacy, minimizes associated risks, broadens intended use or makes unsubstantiated superiority claims, is not allowed, says FDA. Also see NRG, Misbranding Review, DMEPA.

Focus Group

A focus group is a group of invited or topic-knowledgeable people who jointly participate in an interview that is “moderated” rather than using a structured question-and-answer methodology. Usually an exploratory technique, a group consists of 8 to 12 target-market respondents. Also see Qualitative Research.

Food And Drug Administration (FDA)

The regulatory body in the USA responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, products that emit radiation, and tobacco products.

(Therapeutic) Franchise Brand

In Pharma, a Therapeutic Franchise Brand is usually a suite of drugs related by therapeutic area, therapeutic action, or target population marketed as a brand endorsed by the existing corporate identity. The advantage of creating a franchise brand is that it can highlight the therapeutic expertise of the corporate endorser while also allowing the endorsed brand to build its own personality and targeted messages. Examples include Boehringer Ingelheim BioXCellence and Genentech BioOncology.

Gary Martin Group (GMG)

See Our Story.

Generic Name

The term "generic name" regarding drugs has multiple meanings:

A term referring to the chemical makeup of a drug rather than to the advertised brand name under which the drug is sold
A term referring to any drug marketed under its chemical name without advertising

Every medicine has an approved generic or nonproprietary name. If several companies make it, each will also give the drug a brand name (proprietary name). So the same drug may have only one nonproprietary (or "generic" name) and one or more proprietary names. For example, fluoxetine is the generic name (or nonproprietary name) of an antidepressant drug. Eli Lilly won FDA approval for fluoxetine in 1987 and it was marketed as Prozac®, and later, Sarafem®. Today, fluoxetine is marketed under its generic name by other companies. Synonyms: Established name, Nonproprietary name. Also see Drug Nomenclature, USAN and INN.

Global Brand

A global brand is a brand that operates on a worldwide basis. Most pharmaceutical brands are global brands, requiring global brand names. See Blockbuster Brand.

Drug Nomenclature

Health Canada (HC)

The organization in Canada that regulates medical information and nomenclature. Also see Proprietary Names.

Healthcare Professionals (HCP)

A healthcare professional or provider is an individual who provides preventive, curative, promotional or rehabilitative health care services in a systematic way to people, families or communities. For market research purposes, HCP usually refers to recruitment of physicians and nurses.

Incidence

In market research, the number of a certain set of individuals in a given population. For example, the incidence of gastroenterologists among physicians may be 10%. Also, in medical research it can relate to the number of new cases of a disease (or event) occurring per time period (usually one year) in a given population.

Infix

A letter string inserted into the body of a proprietary name or word. For example, "jet" is an infix (a metaphor for speed of recovery) in the drug name Perjeta®.

Ingredient Branding

Ingredient branding is a marketing strategy where a component or an "ingredient" of a product or service is promoted and spotlighted with its own identity and often its own trademark. Ingredient branding is a way of demonstrating the perception of something different or better (e.g. quality) than the competition due to what's inside the product. “Intel Inside” is the poster child for ingredient branding. Other famous examples include Chevron gasoline with Techron®, stereos with Dolby® noise reduction, Nutrasweet® sweetener and Teflon® coating. Ingredient branding is not as prevalent in Pharma marketing, although there are some examples where the drug delivery technology is leveraged in branded products by incorporating part of the technology name into the brand name: Viadur® uses DUROS® technology; Duragesic® DTrans® is from D-Trans® technology; and Adalat® Oros®/XL uses OROS® technology. This naming practice helps promote technological leadership and product reliability.

Intent To Use (ITU) Application

Regarding trademarks in the USA, this refers to the intent-to-use filing basis provided for in Trademark Act Section. Applicants who have not yet used (in commerce) the mark they wish to register may file a trademark application under this filing basis. This filing is useful for Pharma companies who have a product under development in clinical trials and multiple name candidates under consideration.

International Nonproprietary Names (INN)

An international nonproprietary name (INN) is an official generic and nonproprietary name given to a pharmaceutical drug or active ingredient. INN's facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. INNs attempt to make communication precise by providing a unique standard name for each active ingredient, unlike the proprietary name of which there can be several brand names for the same drug. Synonyms: Generic Name. Also see Nonproprietary Name, Drug Nomenclature, and USAN.

International Trademark Association (INTA)

The International Trademark Association (INTA) is the giant global association of trademark owners and professionals dedicated to supporting trademarks and related intellectual property in order to protect consumers and to promote fair and effective commerce.

Investigational New Drug (IND)

The FDA's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Sponsor companies must have an IND to apply for a United States Adopted Name (USAN).

(Japanese) Ministry of Health, Labour, and Welfare (MHLW)

The organization in Japan that regulates medical information and nomenclature. Also see Proprietary Names.

Key Opinion Leader (KOL)

Key Opinion Leaders are physicians who influence their peers' medical practice, including but not limited to prescribing behavior. Also called "thought leaders," their opinions are often factored into biopharma marketing strategies. KOLs are also used for brand naming development and to help identify Drug Class Name alternatives.

"Knockout" Prescreening

One of the most efficient measures in the drug naming process is to do a simple prescreening search early in the name creation phase to eliminate weak name candidates that would be unadvisable to move to more costly in-depth searching. To get a view of the global landscape, and to ensure that valid candidates are not eliminated, "knockout" prescreening often searches legal databases for identicals and near-identicals, online screening, corporate and big brand screening, linguistic screening, and domain name availability.

Label

The description of a drug product/device supplied by the manufacturer, packer, or distributor that includes: the indication, who should use it, adverse events, instructions for use, and safety information. Labels must be approved by regulatory authorities. Also see Product Information.

Likelihood of Confusion for a Trademark

Regarding trademarks, the principal legal factors considered by attorneys in determining whether there is a likelihood of confusion between trademarks are:

The similarity of the marks
The commercial relationship between the goods and/or services listed in the application.

Likert Scale

A balanced rating scale used in a questionnaire in which a respondent is asked to indicate extent of agreement with a series of statements, using a set of verbal categories from “strongly agree" to “strongly disagree” for indicating response.

Lifestyle Drug

Medicines treating conditions or problems that are considered (by some) to be less than higher medical needs––for example baldness, impotence, wrinkles. The popularity of Viagra® caused the medical industry and others to debate the impact of lifestyle drugs use. The brand names of some "lifestyle drugs" are Propecia® (baldness), Botox® (wrinkles), Kybella® (reduce chin fat), and Nicotrol® (smoking).

Linguistic Evaluation

This refers to the practice of assessing potential brand name candidates in major languages/cultures/ethnic groups. A comprehensive linguistic evaluation uses linguistic experts to assess names based on how the whole name functions, not just its individual parts. They diagnose each name for potential problems using these areas of inquiry: Pronunciation, Literal Meaning, Word Similarity, Connotations, Existing Use, Appropriateness, and Brand Image.

Logotype

Logotype is the distinctive way a company, product or service name is designed; its stylized lettering. It typically incorporates a simple graphic treatment often separate from the icon/symbol. Also see Wordmark.

Look-Alike/Sound-Alike (LASA) Drug Names

Many drug names (both nonproprietary names and proprietary names) look or sound like other drug names, and the possibility of confusing these tens of thousands of drug names is one of the most common causes of medication error. Therefore, regulatory authorities conduct Name Safety Reviews to help prevent LASA drug name proliferation. The Institute for Safe Medication Practices (ISMP) posts a listing of "Confused Drug Names" actually involved in medication errors (called LASA name pairs). Also see POCA.

Madrid Protocol

An international treaty that allows a trademark owner to seek registration in any of the countries that have joined the Madrid Protocol by filing a single application. Also see WIPO, USPTO.

Marketing Authorization Application (MAA)

The MAA is an application submitted by a drug manufacturer seeking permission to bring a new medicine to the market in the EU. Similar to NDA in the USA.

Marketing Metrics

The set of market research measures that helps firms quantify, compare, and interpret their drug name candidates.

Medication Error

As defined by FDA, a medication error is "any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use."

The risk of medical errors is substantial. In the USA, it has been reported that approximately 25% of medication errors result from confusion with drug names that look or sound alike (ISMP Medication Safety Alert! 19 Apr 2000;(5)8). Therefore, to help prevent medication errors due to drug names, regulatory authorities worldwide usually conduct a name safety review of proposed new proprietary names before drug approval. Also see Name Simulation Studies.

Megabrand

See Blockbuster Drug.

Misbranding Review

In addition to potential LASA confusion with the proprietary names of other products, FDA also evaluates proposed proprietary names for misbranding concerns (as should sponsor companies too). In determining whether a name is misleading, common morphological and semantic associations are considered along with phonesthemes (the sound of the name) and phonosemantics (meaning conveyed by the sound of the word) of the name. A proprietary name may misbrand the product:

By suggesting that it has some unique effectiveness or composition when it does not
If the name contains or sounds like it implies superiority by suggesting that it has advantages when compared to other available therapies and is better than other available therapies (in the absence of appropriate scientific evidence to support such claims)

Also see Fanciful Name, DMEPA.

Modifier

Some proprietary drug names have added words or components, which are referred to as modifiers (but also known as descriptors and suffixes). The modifier portion of a proprietary name might consist of one or more letters, numbers, and/or words, and might be attached to the beginning or end of the proprietary name. Modifiers usually depict the delivery device component but may also convey distinguishing product characteristics (e.g. indication, formulation, dosing schedule, etc.). Some different modifier examples are Aralast® NP, Advair Diskus®, Caverject Impulse®, Humalog® Kwikpen, Novolin® 70/30 Innolet, and Spiolto® Respimat®.

The modifier can also be used as a strategic tactic to help extend the brand's equity. Procardia® and Procardia® XL (Extended Release) and Paxil® and Paxil® CR (Continuous Release) exemplify this strategy.

From a regulatory standpoint, drug name modifiers are reviewed and approved like drug names. Regulatory authorities note that the absence of a standardized meaning for modifiers and their inconsistent use can be confusing, and misinterpretation of the intended meaning of the modifier has led to medication errors.

Name Review Group (NRG)

In the European Union, the (Invented) Name Review Group (NRG) was established by the Committee for Medicinal Products for Human Use (CHMP) to perform reviews of the (invented) names of medicinal products being assessed by the Agency. The group's main role is to consider whether the (invented) name proposed by a product's manufacturer could create a public-health concern or potential safety risk. This forms part of the agency’s role in evaluating the safety of medicinal products in the centralized marketing authorization procedure. In particular, the drug name should not:

Convey misleading therapeutic or pharmaceutical connotations;
Be misleading with respect to the composition of the product;
Be liable to cause confusion with the name of an existing medicinal product in print, handwriting or speech.

The group's responsibilities also include updating the relevant guideline on the acceptability of invented names.

Name Safety Review

Before a drug is approved for marketing by regulatory authorities (e.g. FDA, EMA, HC, MHLW), the proposed proprietary name is reviewed for safety reasons. It is important that the written or spoken proprietary name not look or sound like that of another proprietary name or nomenclature. If there is similarity between the name of a new prescription drug and the name of an existing drug, a mix-up could occur in ordering and a patient could receive one drug instead of the other, known as a medication error. Errors can occur due to illegible handwriting, orally communicated prescriptions, similar labeling or packaging of medications, and incorrect selection of drug names that may appear in close proximity (e.g., ZYPREXA/ZYRTEC) when entering orders into electronic order entry systems. Another review of the proposed proprietary name is misbranding concerns. Drug names should not convey uniqueness without substantiation, nor should they suggest superiority.

In the USA, FDA’s Division of Medication Error Prevention and Analysis (DMEPA) is responsible for proprietary name review prior to approval by the Center for Drug Evaluations and Research (CDER); in Europe, the Name Review Group (NRG) was established by the Committee for Medicinal Products for Human Use (CHMP) to perform proprietary name reviews; in Canada, it is Health Canada (HC); and in Japan, the organization that regulates medical information and nomenclature is called the Ministry of Health, Labour and Welfare (MHLW). Sponsor companies are encouraged to conduct their own professional name safety review prior to seeking drug approval in order to avoid a delayed launch.

Name Simulation Studies (NSS)

FDA Name simulation studies test how healthcare professionals (HPC) respond to new proposed proprietary names by asking them to use the name in simulated real-world use conditions. The scope of the studies as described by FDA is as follows:

"Name simulation tests should reflect the full range and variety of tasks involved in the prescribing, transcribing, dispensing, and administration of drugs, as well as tasks involved in consumer selection of OTC drugs. Simulations should include common and easily simulated characteristics of real use, such as using ruled or unruled paper, prescription pads, computer order entry, and telephone orders to approximate written, oral, and electronic prescribing in the setting of care for the proposed product (e.g., inpatient and outpatient settings, long-term care). Simulations also should approximate the diversity of real-world prescribing conditions by varying factors such as background noise, handwriting samples, different ink colors, directions for use, and different voices/accents. In addition, the simulation study should present the proprietary name with the corresponding product characteristics (e.g., strength, route, dosage, and frequency) that are likely to be used to communicate prescriptions and orders for the proposed product."

Name Types

From a trademark perspective, there are five different types of brand names with varying degrees of distinctiveness and legal protection:

Arbitrary, fanciful and suggestive trademarks are more distinctive and easiest to protect legally;
Descriptive marks are less distinctive but offer legal protection under certain circumstances;
Generic marks never offer legal protection.

Naming Architecture

The logical structure of names and nomenclature in an organization, the relationship between them, and the reasons why they are structured that way. Once put in place, naming architecture is the company guide for future brand name and nomenclature development. In Pharma, an effective naming architecture could involve establishing constructs, rules, and names for a company's pipeline assets (e.g. company code names), its proprietary technologies, clinical trial branding, franchise identities, and proprietary product portfolio. Also see Drug Nomenclature.

Neologism

A coined, made-up word. Aspirin, originally the brand name created by Bayer for acetylsalicylic acid, is a neologism. Synonym: Coined Name.

New Drug Application (NDA)

An application to FDA for a license to market a new drug in the United States. Also see BLA.

New Molecular Entity (NME)

New Molecular Entity is a drug or chemical that is without precedent among regulated and approved drug products. The NME designation indicates that a drug in development is not a version or derivative of an existing and previously investigated, trialed and approved substance. Being labeled as entirely 'new' or first-in-class molecule dictates that certain types of clinical trials must be run, and that particular attention must be paid to proving a drug's safety. Also, sponsor companies With a NME designation should look to develop a new nonproprietary name stem and a new drug class name (segment identifier).

Nonproprietary Name

A nonproprietary name (often called a "generic name") is the name assigned to the chemical or other active ingredient that is not subject to trademark (proprietary) rights but is, in contrast to a trivial name, recognized or recommended by government agencies (for example, FDA) and by other organizations (like USAN) for general public use. Every drug has a unique nonproprietary name, however, part of the name, called a "stem" is shared with other drugs of the same drug class. For example, celecoxib (Celebrex®), rofecoxib (Vioxx®) and valdecoxib (Bextra®), all share the -coxib suffix stem, which identifies them as cox-2 inhibitor drugs. The official international nonproprietary name is assigned by the World Health Organization (WHO). Many pharma companies in the USA start developing nonproprietary names in phase I or in early phase II, after obtaining an IND (Investigational New Drug) application. Also see Drug Nomenclature, Generic Name, International Nonproprietary Name.

Office of Surveillance and Epidemiology (OSE)

At FDA, the Office of Surveillance and Epidemiology (OSE) evaluates drug risks and promotes the safe use of drugs (formerly the Office of Drug Safety). Also see CDER, DMEPA.

Online Panel

An Online panel is a group of selected research participants who have agreed to provide information at specified intervals over an extended period of time.

Orphan Drug

Orphan Drug designation (or status) is granted by the FDA for drug products meeting certain criteria upon a sponsor company's request. It refers to products developed in the USA for rare or unprofitable indications with tax or patent concessions (as an incentive to develop the product/service).

Palindrome

A palindrome is a word, phrase, number, or other sequence of characters that read the same backward or forward. In Pharma, the palindrome naming tactic is well served in Pharma, such as Xanax®, Raxar®, Lexxel®, Lozol®, and Merrem®. Also see semordnilap.

Parallel Imports

Parallel imports are imports of a patented or trademarked product from a country where it is already marketed. Importers buy products from distributors in one country and sell them in another to distributors who are not part of the manufacturer’s normal distribution chain. Sometimes called “grey market” imports, parallel imports usually take place when price differences exist for the same product between countries. A strategy employed by some Pharma companies to avoid parallel importation is to create different brand names in different countries for the same product.

Patent

A temporary monopoly given by law to an inventor to allow the inventor to prevent others from exploiting the invention. Term of the monopoly varies from country to country but is usually 15-20 years. In Pharma, companies apply for drug patents long before the clinical trial to assess a drug’s safety and efficacy has commenced. The effective patent period after the drug has finally received approval is often around seven to twelve years. Once the patent has expired, the drug can be manufactured and sold by other companies. Also see Trademark, Generic Name.

Patient Advocacy Groups

Patient advocacy is an area of lay specialization in health care concerned with advocacy of patients, survivors and caregivers. Advocacy groups are usually lobbying groups, on behalf of patients with specific diseases. Typical advocacy activities include patient rights, matter of privacy, confidentiality or informed consent, patient representation, awareness building, support and education of patients, survivors and their caregivers. Advocacy groups are sometimes consulted for clinical trial branding insights.

PBRIG (also known as Pharmaceutical Business Intelligence & Research Group)

The PBIRG is a not-for-profit industry association dedicated to the advancement of global healthcare marketing research, business intelligence, and strategic planning in theory and practice.

Pet Name

See Drug Nomenclature.

PhRMA (also known as Pharmaceutical Research & Manufacturers of America)

PhRMA represents the country’s leading biopharmaceutical researchers and biotechnology companies. PhRMA's mission is to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical / biotechnology research companies.

PMRG (also known as Pharmaceutical Marketing Research Group)

PMRG is an independent, member-based, not-for-profit association that advances the principles, practice and power of healthcare marketing research by creating a community that supports individual professional development and acts as an advocate for the profession as a whole.

PTMG (Pharmaceutical Trade Marks Group)

PTMG is a not-for-profit organisation. The primary objective of PTMG is to enable members to meet at regular intervals to consider problems of mutual interest. It does this by running educational conferences relating to the law and practice of trademarks and other intellectual property particularly as they affect pharmaceutical and related industries. The conferences for its members meet twice a year.

POCA (also known as Phonetic and Orthographic Computer Analysis)

POCA is an analytic tool designed to help identify drug names and medical terminology that are phonetically and orthographically similar to one another to reduce potential medication errors. In the USA, Division of Medication Errors Prevention and Analysis (DMEPA) evaluates all proprietary names submitted to the Center for Drug Evaluation and Research (CDER) for similarity to other marketed names. The POCA system comprises lists of pre-existing pharmaceutical product names (along with other relevant information, e.g., dosage). A proposed name is entered in the POCA system and it queries the name against drug reference databases through an algorithm that weighs orthographic and phonetic similarities. This query results in a list of the most similar pre-existing names along with the combined POCA score for each result. The higher the POCA score for an entry, the more similar the proposed name is to other existing names, and the less likely that FDA will accept the proposed name. Also see OSE, DMEPA.

Portmanteau Name

Any brand name created by the whimsical or strategic blending of two or more other words or morphenes. For example, brunch, which is a combination of "breakfast" and "lunch." In Pharma, portmanteau names abound: Prevacid® (from "prevent" + "acid"), Botox® ("botulism" + "toxin"), Lipitor® ("lipids" + "atorvastatin"), Genentech ("genetic" + "engineering" + "technology"), Hospira ("hospital" + "inspiration").

Positioning

Popularized by Al Ries and Jack Trout in their bestseller book "Positioning - The Battle for Your Mind" (McGraw-Hill 1981), positioning is the strategy of creating a "position" that reflects a company's or product's differentiation, relative to competing brands, in a prospective customer's mind.

Positioning defines where your product (item or service) stands in relation to others offering similar products and services in the marketplace in the mind of the consumer. Also see USP.

Prescreening

See Knockout Prescreening.

PDUFA (also known as Prescription Drug User Fee Act)

In the USA, PDUFA is a law passed by the United States Congress in 1992 that allowed the Food and Drug Administration (FDA) to collect fees from sponsor companies to fund a more efficient drug approval process. PDUFA dates are deadlines for the FDA to approve new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted 6 months to review the drug. For drug naming, sponsor biopharma companies must “have a brand name by the PDUFA date.” Also see Action Date.

Product Characteristics

The physical characteristics of the product itself (i.e., dosage form, strength, active ingredient) and environment in which the product is used, including but not limited to the established name, label, labeling, container, facility, storage conditions, who prescribes and administers the product, patient population, and other conditions of use. Also see Product Information, Brief.

Product Concept

Usually verbal and/or pictorial representation of a new product or service, normally described by its features and benefits.

Product Information (PI)

The approved product information (PI) is a summary of the scientific information relevant to the safe and effective use of a prescription medicine, such as indication, precautions, dosage, and administration. The pharmaceutical industry regards the approved product information (PI) as an extremely important. The underlying philosophy is that the PI should ensure the safe and effective use of the drug, be a scientific, objective account of the drug's usefulness and limitations, and be devoid of promotional material. Also see Brief.

Proof Of Concept (POC)

Evidence that demonstrates that a pipeline asset is feasible. Many Pharma companies wait for POC to begin brand name development.

Proprietary Name

A commercial name of a product or service registered by its owner as a trademark and not usable by others without permission. The trademark or brand name is often further distinguished by a superscript R in a circle (®). Perjeta®, Spiolto® are two examples. Synonyms: Brand Name, Trade Name. Also see Drug Nomenclature.

Qualitative Research

Marketing research to explore opinion and value judgments of individuals from which collective general conclusions may be drawn. The researcher looks for themes and describes the information in patterns exclusive to that set of a smaller focused sample of participants rather than a large sample. Such research usually involves focus group discussions or depth interviews. Also see Verbatims.

Quality Of Life (QOL)

In healthcare, QOL is a subjective self-appraisal of perceptions, functioning, opportunities and satisfaction with life. QOL measures have been used in clinical trials to help understand patient problems better.

Quantitative Research

A research method usually with questionnaires involving a large number of respondents so the information obtained from them can be used to help make decisions or to create strategic plans, usually based on statistical analysis of the results. Quantitative data is any data that is in numerical form such as statistics, percentages, etc. Also see Top-Box Score.

Real Word Name

It is a brand naming style that uses a part of a 'real' or existing dictionary word in its name. The effect can be wide-ranging, from arbitrary to descriptive to suggestive (depending on the language applied). Celebrex®, Augmentin® and Invokana® are just a few of the "real word" drug names.

Scientific Name

See Drug Nomenclature.

Scientific Statements

Scientific Statements are comprehensive, indication-specific statements based on the specific scientific details and covering all aspects of the use and expectations of a new drug brand. Scientific Statements help make it easier for sponsor companies to explain in layman's terms how their brand works and what it stands for when commercialization becomes reality. The need for sponsor companies to create Scientific Statements early in the developmental phases becomes obvious when their science is so novel that no common nomenclature exists to explain it; or when researchers identify the same therapeutic activity using multiple terms. The purpose, then, is to consistently use the statements in early-stage press releases and other patient and professional publications so everyone is using the same language when referring to the brand. The advantages gained by sponsor companies using Scientific Statements are many:

Creates a scientific brand advantage
Helps build a platform for branding
Establishes distinction for an pipeline asset
Assists the education/communication plan
Establishes an accurate and ownable sound bite for the brand
Identifies the most common terminology for use

Segmentation

The breakdown of a market into discrete identifiable groups, each of which may have its own (similar) special needs or characteristics, e.g. demographics, attitude, behaviors, diagnoses, treatments or other characteristics.

Segment Identifier

See Drug Class Name.

Semi-Umbrella Branding

A group of products possessing a part of the same name. Also see Umbrella Branding.

Semordnilap

A close kin to the palindrome is the semordnilap. A semordnilap––which is a reverse spelling of 'palindromes'–– is the term given to a word that becomes another word when written backwards, or reversed. "Decaf" and "faced" are examples. A playful corporate example is Oprah's production company, named Harpo. In the drug naming space, the only attempt at a semordnilap brand name that we are aware of is Orenitram®, derived from the United Therapeutics CEO's name, Martine Ro(thblatt). Also see Palindrome.

Standard Operating Procedure (SOP)

Detailed, written instructions to achieve uniformity of the performance of a specific function. For drug nomenclature, SOPs have been developed to help companies internally manage the who, what, when, where, why, and how of developing nomenclature and brand names for products in the pipeline. Not to be confused with SOW (Statement of Work).

Statement Of Work (SOW)

A Statement of Work (SOW) is a document that defines project-specific activities, deliverables and their respective timelines, and fees, all of which can form a contractual obligation upon the vendor in providing services to the client. As is sometimes the case with drug naming projects, a SOW is developed before a more formal and detailed proposal is requested so that both parties understand the project scope. Not to be confused with SOP (Standard Operating Procedure).

Stem

Current drug nomenclature practices involve the adoption of standardized syllables called "stems" in a drug’s nonproprietary name (sometimes referred to as a USAN or INN stem). Stems, either prefixes, suffixes or infixes, relate new chemical entities to existing drug families. Each stem can emphasize a specific chemical structure type, a pharmacologic property, or a combination of these attributes. Stem examples include –ciclovir, –lizumab, and –statin. Regulatory agencies advise against incorporating USAN or INN stems in potential proprietary names, especially in the suffix position. Also see USAN, INN and Drug Nomenclature.

Storyboard

A sequence of illustrated proposals or visuals describing scenes of a proposed commercial, sales detail or promotional campaign. In brand naming, storyboards can serve as visual metaphors for understanding the name creation direction.

Suggestive Name

These names imply or put forward a quality or characteristic without describing it, that when applied to the goods or services being referenced, can ignite imagination, thought or perception about the nature of those goods or services. Pharma examples include: Enablex®, Exubera® and Repatha®.

Tagline

A short descriptor or group of words used to summarize the brand position, usually aligned with the brand name. Synonym: Strap Line.

Tall Man Lettering

Tall Man lettering (or Tallman lettering), a term coined by the Institute for Safe Medication Practices (ISMP) in the late 1990s, is the practice of writing part of a drug’s name in upper-case letters to help distinguish sound-alike, look-alike drugs from one another in order to avoid medication errors, e.g. PriLOSEC® and PROzac®.

Target Product Profile (TPP)

A Target Product Profile (TPP) is a planning tool for therapeutic candidates based on FDA Guidance for Industry. It includes information relevant to the proposed product label, such as description, indication/s, dosage, strengths, etc. The TPP is also a useful tool for setting up the drug-naming Brief.

Time To Market (TTM)

The length of time it takes from initial conception to product approval, or until a product is available for sale. TTM is a major consideration for brand name planning and for strategic planning in the pharmaceutical industry. It can be an important success factor for first-in-class assets. Also see Drug Nomenclature.

Top-Box Score

The percentage of respondents who gave the highest or top score on a scale. Sometimes the top two or three scores may be aggregated to calculate a "top boxes" score. Also see Quantitative Research.

Topline Report

A brief summary of the main findings of a market research study.

Toponym

A brand-naming technique based on reference to a place or geography. It is used effectively in car naming, e.g. Chrysler Newport. Not seen too often in drug naming, although doxorubicin was reportedly discovered in Italy near the Adriatic Sea, hence the brand name Adriamycin®.

Trade dress

A product’s design, product packaging, color, or other distinguishing nonfunctional element of appearance.

Trademark

Trademarks, when adopted and used by a manufacturer, protect words, names, symbols, sounds, or colors that distinguish goods and services from those manufactured or sold by others. Trademarks, unlike patents, can be renewed forever as long as they are being used in commerce. Also see Proprietary Name.

Train Wreck Scenario

The "train wreck scenario" refers to a drug regulatory situation where the owner of a valid trademark with conditional regulatory approval (Pharma A) is denied using their drug name by authorities (at FDA, for example) due to a similar drug name (from Pharma B) also under consideration for approval. This can occur with a "fast-tracked" product, where Pharma B’s name approval process starts after Pharma A’s, but its name is approved ahead of Pharma A’s. Hence, a "train wreck" because Pharma A’s brand name is rejected at the last minute. The learning is that FDA brand name approvals are conditional and not final until 90 days before the product’s Action Date.

Trivial Name

See Drug Nomenclature.

Umbrella Branding

Umbrella branding is a powerful branding practice (also known as "family branding" and "brand name extension") where a group or similar line of products possesses the same brand name. Often used in over-the-counter (OTC) medicines branding, examples include Advil®, Bayer®, and Mucosolvan®. Advantages are cost efficiency and brand leverage. Also see Semi-Umbrella Branding.

Unique Selling Point or Unique Selling Proposition (USP)

The "unique selling point" is the benefit that serves to differentiate the product or service from similar entities. Commonly stated just as "USP." Examples include: DeBeers®––"A diamond is forever"; and the OTC brand NyQuil®––“Nyquil – the nighttime, sniffling, sneezing, aching, coughing, stuffy-head, fever, so you can rest medicine.”

United States Adopted Name (USAN)

The USAN program is organized to produce nonproprietary names for drugs and other agents in the USA. A USAN is required for USA marketing approval. USAN name candidates can be submitted early on in the clinical investigation stage after an IND number is assigned. USAN name acceptance and the international harmonization process are usually sequential. Once an applicant has accepted a USAN Council recommendation and sends payment for the International Nonproprietary Name (INN) application, the name is sent to and deliberated by the INN Expert Committee at either the fall or spring meetings after which the applicant is informed of the decision regarding the INN. USAN makes available the list of common stems for which chemical and/or pharmacologic parameters have been established. The use of these stems in drug names is generally prohibited. Synonyms: Generic Name. Also see International Nonproprietary Name and Drug Nomenclature.

United States Patent and Trademark Office (USPTO)

The United States Patent and Trademark Office is an agency in the U.S. Department of Commerce that issues patents and trademark registrations for product and intellectual property identification. It is also a useful search database for trademark registrations and applications by mark, owner, or serial/registration number is their Trademark Electronic Search System (TESS). Also see WIPO.

Verbal Identity

The verbal identity is the brand name and other verbal nomenclature elements that identify the brand (e.g. taglines, words, phrases, etc.). These coordinated elements help make a brand distinctive and are part of the brand name strategy. Also see Drug Nomenclature.

Verbatims

In market research, transcribing or recording the provided responses of respondents in their exact words. "Verbatims," or verbatim responses, help paint a more vivid picture of the research goal. Also see Qualitative Research.

Visual Identity

The visual elements of a brand or company, usually referring to logo, packaging, brand colors, fonts, styles; but can also mean the overall image or brand aesthetic being conveyed. The brand visual identity is usually pursued following brand name development.

Voice

Is the personality of a brand when expressed verbally with a consistent style and tone.

W - X - Y - Z

Wordmark

The stylized typographic treatment of a brand name, absent an attached icon/symbol. Also see Logotype.

World Health Organisation (WHO)

WHO's primary role is to direct and coordinate international health within the United Nations’ system. It also develops international norms and standards, such as recommending International Nonproprietary Names (INN), so that countries worldwide can regulate health products and technologies consistently.

World Intellectual Property Organization (WIPO)

An intergovernmental organization of the United Nations system headquartered in Geneva, WIPO is responsible for the promotion of the protection of intellectual property throughout the world and for the administration of various multilateral treaties dealing with the legal and administrative aspects of intellectual property. WIPO currently has 189 member states, administering 26 international treaties.