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Naming -

Naming drugs is a process that involves several stages. It begins with a chemical name and moves on to a generic and then a brand name. Each of these steps reflects specific rules in order to ensure it is safe for use.

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Chemical makeup -

In the beginning phase of development, a drug's name is reflected in its chemical makeup. For example, N-(4-hydroxyphenyl) acetamide is the chemical name for acetaminophen (generic name) sold as the brand name Tylenol.

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The science behind it all -

Before a clinical trial, drugs will get their generic name. Typically drug companies file between three and six generic suggestions to the United States Adopted Name Council (USAN), which includes members of the American Medical Association, American Pharmacists Association, and U.S. Pharmacopeia.

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What is a generic drug? -

A generic drug should be the exact same as the brand-name marketed drug in terms of dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.

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Choosing a suffix for a drug -

The stem of a drug's name reflects how the drug works within the body. For example "-oxetine" such as fluoxetine and paroxetine are SSRIs that treat mood disorders.

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Things companies can’t do -

There are several rules, like which letters the generic prefixes can't use. They include H, J, K, W, or Y, as these letters may not exist in all languages or resemble other generic drugs sharing the same suffix. Additionally, they can't reflect or promote the name of the drug company.

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Approving a name - The USAN and World Health Organization’s International Nonproprietary Names (INN) expert group ensures that a generic drug name is easy to pronounce and remember as well as has a suffix that accurately reflects what the drug does. Finally, the drug name should translate well into non-English languages.

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Same name worldwide -

A generic drug name should be the same worldwide. Even if the brand name varies, the generic name being the same lowers the risk of medication errors when traveling internationally.

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How do brand-name drugs get their names? -

Companies often use focus groups and research to select one name from as many as 200 options.

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Focus groups and research methods -

These focus groups and other methods help companies refine their choices to ensure the name resonates with healthcare providers and patients while being memorable and easy to use.

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Companies might try to come up with a brand name -

Sometimes companies will try to come up with a brand name that is reflective of what the drug does. An example might be Lyrica, which helps treat nerve pain. The name evokes soothing music lyrics and alludes to the soothing of nerves.

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Approval -

Drug companies can submit only one brand name to the FDA and up to two to the European Medicines Agency (EMA).

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Vetting process and third name -

By the time a medication is released with its official brand name, it has undergone three iterations and names—the chemical drug name, a generic drug name, and finally, the brand drug name.

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FDA and EMA requirements -

The FDA and EMA have requirements when it comes to a drug's brand name. It cannot look or sound too similar to another branded drug, it must avoid medical claims such as "rapid," and it can't resemble the generic name too closely. 

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Rejection -

If a brand name is rejected by the FDA or EMA then the company must start over. This can mean a lot of extra time and cost for the company and ultimately a delayed release to the market.

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How long can choosing a name take? -

Given the processes outlined previously in this gallery, the entire naming process of a drug can take up to four years.

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How much is spent developing a new name? -

The amount a drug company spends to get a new drug to market can vary greatly. Even just working with a consulting firm to develop a name can cost drug companies up to half a million dollars.

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Why does a generic drug look different from the branded one? -

US trademark laws don't allow generic drugs to look exactly like brand drugs. Though they may share the same active ingredients, the inactive ingredients like colors and flavors may be different. 

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What standard must generic medicines meet to receive FDA approval? -

In order for the FDA to approve a generic drug it must be bioequivalent to the brand drug and meet strict requirements for strength, safety, performance, and intended use.

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ANDA requirements -

Drug companies must submit an Abbreviated New Drug Application (ANDA) proving the generic drug is equivalent to the brand drug in active ingredient, strength, dosage form, administration route, as well as stability and manufacturing quality.

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The generic medicine is the same strength -

Generic drugs and brand-name drugs must have the same strength. This helps to ensure similar therapeutic effects.

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It lasts for at least the same amount of time -

Generics undergo stability tests to ensure they last as long as brand drugs.

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It is manufactured under the same strict standards as the brand-name medicine -

Generic drugs must meet rigorous FDA manufacturing standards for consistency, strength, purity, and quality.

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The label is the same as the brand-name medicine's label -

Aside from information protected by patents and exclusivities, generic drug labels must mirror those of their brand name equivalent.

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Relevant patents or exclusivities are addressed -

Drug companies are awarded patents and exclusivities as an incentive to develop new medicines.

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Summary of how drugs get their names -

Naming a drug can take a lot of careful consideration of the chemical composition and therapeutic use. Additionally, it's important to keep the global safety standards in mind. Names are vetted for clarity, accuracy, and compliance with international naming standards.

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Why understanding drug naming matters -

Understanding the naming process helps healthcare providers and patients identify medications accurately, reducing errors and ensuring effective treatment.

Sources: (Clevland Clinic) (Pfizer) (FDA)

See also: Medicine side effects and how to deal with them

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