Drugs often have several names. When a drug is first discovered, it is given a chemical name, which describes the atomic or molecular structure of the drug. The chemical name is thus usually too complex and cumbersome for general use. Next, a shorthand version of the chemical name or a code name (such as RU 486) is developed for easy reference among researchers.

When a drug is approved by the Food and Drug Administration (FDA—the government agency responsible for ensuring that drugs marketed in the United States are safe and effective), it is given a generic (official) name and a trade (proprietary or brand) name. The trade name is developed by the company requesting approval for the drug and identifies it as the exclusive property of that company. For example, phenytoinSome Trade Names
DILANTIN
is the generic name and Dilantin is a trade name for the same drug. When a drug is under patent protection, the company markets it under its trade name. When the drug is off-patent (no longer protected by patent), the company may market its product under either the generic name or trade name. Other companies that file for approval to market the off-patent drug must use the same generic name but can create their own trade name. As a result, the same generic drug may be sold under either the generic name or one of many trade names.

In the United States, an official body—the United States Adopted Names (USAN) Council—assigns the generic name. The company that manufactures the drug develops the trade name. Generic and trade names must be unique to prevent one drug from being mistaken for another when drugs are prescribed and prescriptions are dispensed. To prevent this possible confusion, the FDA must agree to every proposed trade name.

Government officials, doctors, researchers, and others who write about the new compound use the drug's generic name because it refers to the drug itself, not to a particular company's brand of the drug or a specific product. However, doctors often use the trade name on prescriptions, because it is easier to remember and doctors usually learn about new drugs by the trade name.

Generic names are usually more complicated and harder to remember than trade names. Many generic names are a shorthand version of the drug's chemical name, structure, or formula. In contrast, trade names are usually catchy, often related to the drug's intended use, and relatively easy to remember, so that doctors will prescribe the drug and consumers will look for it by name. Trade names often suggest a characteristic of the drug. For example, Lopressor lowers blood pressure, Vivactil is an antidepressant that might make a person more vivacious, Glucotrol controls high blood sugar (glucose) levels, and Skelaxin relaxes skeletal muscles. Sometimes, the trade name is simply a shortened version of the drug's generic name—for example, Minocin for minocyclineSome Trade Names
MINOCIN
.

The term generic, when applied to such items as foods and household products, is used to describe a less expensive, sometimes less effective or lower-quality copycat version of a trade-name product. However, most generic drugs, although less expensive than the comparable trade-name drug, are as effective and of the same quality as the trade-name drug. In fact, generic drug makers manufacture many trade-name products for companies that control the trade names. Sometimes, more than one generic version of a drug is available. For example, many manufacturers sell versions of acetaminophenSome Trade Names
TYLENOL
.

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What's In a Name? Chemical Name Generic Name Trade Name N-(4-hydroxyphenyl) acetamide AcetaminophenSome Trade Names TYLENOL Tylenol 7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one DiazepamSome Trade Names DIASTAT VALIUM Valium 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4'-fluorobutyrophenone HaloperidolSome Trade Names HALDOL Haldol 5-thia-1-azabicyclo [4.2.0]-oct-2-ene-2 carboxylic acid, 7-[(aminophenylacetyl)amino]-3-methyl-8-oxo-, monohydrate CephalexinSome Trade Names KEFLEX Keflex, Keforal, or Keftabs dl-threo-2-(methylamino)-1-phenylpropan-1-ol PseudoephedrineSome Trade Names AFRINOL SUDAFED Sudafed N''-cyano-N-methyl-N'-[2-[[(5-methyl-1H-imidazol-4-yl) methyl]thio]ethyl]guanidine CimetidineSome Trade Names TAGAMET Tagamet

Patent Protection

In the United States, a company that develops a new drug can be granted a patent for the drug itself, for the way the drug is made, for the way the drug is to be used, and even for the method of delivering and releasing the drug into the bloodstream. Thus, a company often owns more than one patent for a drug. Patents grant the company exclusive rights to a drug for 20 years. Additional patents can sometimes be filed to extend the patent life. Usually, about 10 years elapse between the time a drug is discovered (when the patent is obtained) and the time the drug is approved for human use, leaving the company only about half of the patent time to exclusively market a new drug. The FDA may choose to accelerate the approval process for drugs to treat AIDS, cancer, and other life-threatening disorders when no current effective treatment exists.

After a patent has expired, other companies may produce and sell a generic version of the drug as long as the FDA has approved it. They typically sell their product at a lower price than the original trade-name drug because the generic manufacturer does not have to recover the original costs of drug development and usually spends much less on marketing. A generic drug may be sold under its generic name or under a trade name (a branded generic drug) but not under the trade name used by the original patent-holder.

Not all off-patent drugs have generic versions. Sometimes a drug is too hard to duplicate, or adequate tests are not available to prove that the generic drug acts the same as the trade-name drug. Sometimes the market for the drug is so small that producing another version does not make good business sense.

Nonprescription Generic Drugs

Generic versions of some nonprescription (over-the-counter) drugs are often sold as house brands by drug chains or cooperatives, usually at a lower cost. These drugs are evaluated in the same way that generic prescription drugs are evaluated and must meet the same requirements.

Pharmacists can advise which generic over-the-counter drug products should be as effective as the original. However, a consumer may prefer one product to another because of appearance, taste, consistency, or other characteristics.

Last full review/revision April 2007 by Harold M. Silverman, PharmD