The Hatch-Waxman Act of 1984 catalyzed the generic drug market, which now constitutes over 85% of US prescriptions.1 The number of generic alternatives to a brand-name drug affects prices; availability of at least 4 generic drugs has been associated with brand-name price reductions of approximately 60% when compared with fewer or no generics.2- 4 Recently, prices for several generic drugs have increased 100-fold or more, in part because of limited competition.5 We characterized the number of generic versions for all brand-name drugs approved by the US Food and Drug Administration (FDA), along with associations between the number of generics and characteristics of brand-name drugs.
Gupta R, Kesselheim AS, Downing N, Greene J, Ross JS. Generic Drug Approvals Since the 1984 Hatch-Waxman Act. JAMA Intern Med. 2016;176(9):1391-1393. doi:10.1001/jamainternmed.2016.3411