Chapter 6: Authorized Generics: Look Before You Leap

Authorized generics: Look before you leap In an effort to help retain revenue and lessen the impact of generic erosion, research-based pharmaceutical companies have used a variety of tactics to extend the life of a patented drug with varying degrees of success. One such tactic that has garnered a lot of attention – and spurred a lot of debate – is the use of authorized generics. The term authorized generic refers to a brand-name drug that the originating company repackages and markets as a generic, to ward off pending generic competition. The 1984 Hatch-Waxman amendments to the Food, Drug, and Cosmetic Act encourage early generic entry by providing an incentive for generics companies to challenge brand-name drug patents. During a 180-day exclusivity period, the successful challenger alone is allowed to market its generic product – in essence, an exclusive generic - and compete with the brand-name product and the How ...

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