Market exclusivity in orphan medicines in USA

Published by FDA

Orphan IncentivePaediatric IncentiveMarket Exclusivity

This guide provides an incentive of FDA. Orphan products once they receive a marketing authorisation in USA, they benifit additional 7 years of market exclusivity regardless patent expiration. This incentive is to encourage the development of drugs for rare diseases to prevent from other competitors selling similar drugs for similar diseases.

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