drugs
Overview of Generic Drugs and Drug Naming
Patent Protection for Drugs
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 Food and Drug Administration (FDA) may choose to accelerate the approval process for drugs to treat acquired immunodeficiency syndrome (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 that is approved by the FDA. They typically sell their product at a lower price than the original brand-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 brand name (a branded generic drug) but not under the brand 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 brand-name drug. Sometimes the market for the drug is so small that producing another version does not make good business sense. 