After the US Food and Drug Administration (FDA) approves a new brand-name prescription drug, the drug is protected from generic competition by the combination of 2 market exclusivity mechanisms. Patents cover the intellectual property inherent in the design of a new drug, processes used in manufacturing the medication, and sometimes the application of the drug to clinical practice. Patents last 20 years from the time they are issued, which is usually at least several years before a drug receives FDA approval. Exclusivity, which the FDA grants, supplements patents to ensure that all new drugs have a period of market exclusivity regardless of when their patents were issued.
Downing NS. Market Exclusivity for Top-Selling Pharmaceuticals: Too Long, Too Short, or Just Right? JAMA Intern Med. 2015;175(4):637–638. doi:10.1001/jamainternmed.2014.7972
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