Authorized Generic Drugs: Short-Term Effects and Long-Term Impact
"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 brand’s 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..."