Latest Uproar in Generics:180-day Exclusivity

Executive Summary

Legal strategies are getting ever more sophisticated in the war between generics and brand-name companies. Some generics companies are in an uproar about a new wrinkle in their efforts to bring lower-priced drugs to market; because of a series of court decisions that upset an FDA practice, generics companies that are first to file for approval of a drug in which they think the patent may be challenged are entitled to 6 months market exclusivity. Previously, the FDA required a lawsuit to be underway in order for generics companies to get exclusivity, but now, a company can get the exclusivity just by making the claim that they might be subjected to a lawsuit. Generics companies worry that their competitors will take advantage of the policy by rushing to file sub-standard ANDAs just to be able to get the market exclusivity; in addition, they might try to strike deals with brand name companies that would give them a reward for keeping other generics companies off the market entirely.