Authorized Generic Drugs: Short-Term Effects and Long-Term Impact.

摘要

This Report analyzes the competitive effects of authorized generic drugs (AGs). AGs are pharmaceutical products that are approved as brand-name drugs but marketed as generic drugs. AGs do not bear the brand-name or trademark of the brand-name drug or manufacturer, but the brand-name and AG products are manufactured to the brands specifications. In examining competitive effects, the Report looks both at the price and revenue effects of AG competition and at the potential long-term impacts on incentives for generics to challenge patents on brand-name drugs. The Report also assesses the competitive implications of patent litigation settlements in which brand-name companies refrain from offering an AG when the generic company agrees to defer its entry (so-called pay-for-delay settlements). For more than a decade, the Commission has expressed concern about brand-name companies paying generics to delay entry. As this Report observes, promises not to compete with generic entrants by marketing an AG are a common form of compensation to generics in such arrangements, and the competitive effects of such promises should therefore be analyzed in the same manner as other forms of consideration paid to generics.