FTC Report Examines How Authorized Generics Affect the Pharmaceutical Market

by Sabrina I. Pacifici on September 14, 2011

News release: “The Federal Trade Commission issued a final report, Authorized Generic Drugs: Short-Term Effects and Long-Term Impact, that concludes when pharmaceutical companies introduce an authorized generic version of their brand-name drug, it can reduce both retail and wholesale drug prices. The report also found that authorized generics have a substantial effect on the revenues of competing generic firms. Over the longer term, by lowering expected profits for generic competitors, the introduction of an authorized generic could affect a generic drug company’s decision to challenge patents on branded drug products with low sales. However, the report concludes that in spite of this, patent challenges by generic competitors remain robust. Finally, the report finds that some brand companies may have used agreements not to launch an authorized generic as a way to compensate would-be generic competitors for delaying entry into the market. The FTC has for years opposed pay-for-delay patent litigation settlements, in which a brand-name drug manufacturer compensates its generic competitor to delay entering the market and offering consumers a lower-cost alternative. With this report, the agency has found that promises by a branded firm not to market competing authorized generics are frequently present in pharmaceutical patent settlements.”

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