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In Generics, An Update on Reform

Executive Summary

The new Medicare Act, while aimed at expanding health insurance coverage to include drug benefits, also includes some changes that wiill impact the intricate and highly evolved way generic companies go about challenging patents on brand-name drugs. Specifically, it strengthens an incentive companies have to be first to file a patent challenge, known as 180-day marketing exclusivity. Second, it limits the number of times a brand name company can get a delay on launch of a newly approved generic.

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