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Special Communication
Health Care Policy and Law
November 2017

Determinants of Market Exclusivity for Prescription Drugs in the United States

Author Affiliations
  • 1Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
JAMA Intern Med. 2017;177(11):1658-1664. doi:10.1001/jamainternmed.2017.4329
Key Points

Question  How is the market exclusivity period for brand-name prescription drugs defined?

Findings  Brand-name prescription drug market monopoly periods are usually defined both by patents and regulatory exclusivity earned at the time of approval by the US Food and Drug Administration (about 6-7 years or 12 years for new biologics). In total, most new drugs receive about 12 to 16 years of market protection from the time of US Food and Drug Administration approval.

Meaning  Government-granted market exclusivity protection for brand-name prescription drugs prevent entry of low-cost generic drugs and therefore allow manufacturers to set high prices, recoup their investments, and earn profits. These are hotly contested decisions, with considerable pressure from interested groups. Policy makers frequently try to lengthen these periods to increase pharmaceutical company revenues with the hope that some of these increased revenues will eventually lead to more research and innovation.


The high prices of brand-name prescription drugs are a growing source of controversy in the United States. Manufacturers of brand-name drugs can command high prices because they are protected from generic competition by two types of government-granted monopoly rights. The first are patents on the drugs that generally define the basic period of brand-name-only sales. The second is awarded at the time of US Food and Drug Administration (FDA) approval and usually defines the minimum time until a generic can be sold. The initial patents last for 20 years and may be extended to account for time spent in clinical trials and regulatory review; other laws prevent approval of other manufacturers’ versions of new drugs for about 6 to 7 years, and for new biologics for 12 years. Overall, most new drugs receive about 12 to 16 years of market exclusivity from both kinds of monopoly protection combined. We reviewed the peer-reviewed medical and health policy literature to identify studies that described the different types of patent protection and regulatory exclusivities that shield brand-name prescription drugs from competition and thus help to sustain high drug prices. We also identified potential policy reforms intended to modify exclusivity periods to address public health needs by balancing drug affordability and industry revenue. The goal of policy in this area should be to ensure that drug market exclusivity periods provide for fair return on investment but do not indefinitely block availability of lower-cost generic drugs.

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