Generic Drug Entry Prior to Patent Expiration

2010, Business/Economics, Food Drugs and Cosmetics, Hein's Electronic Documents Reprint Series, Intellectual and Industrial Property admin

An FTC Study

The use of generic drugs has increased exponentially over the past 20 years. When the Hatch-Waxman Amendments were enacted in 1984 to create opportunities for market entry by generic drug manufacturers, generic drugs accounted for 19% of the prescriptions filled for pharmaceutical products. In 2002, when this work was published, they comprised more than 47% of the prescriptions filled. Despite that success, several brand name and generic drug companies arranged anti-competitive agreements to keep certain generic drugs off the market, taking advantage of two exploitable provisions of Hatch-Waxman. Their actions forced the FTC to take antitrust actions against these companies and led to Generic Drug Entry Prior to Patent Expiration: An FTC Study, which examines whether the conduct challenged by the FTC was isolated, or if this abuse is more typical.

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Originally Published (e-version): Washington; Federal Trade Commission; 2002
Reprinted: Buffalo; William S. Hein & Co., Inc.; 2003

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