Rewards and incentives for paediatric medicines in USA

Published by FDA

Market ExclusivityPaediatric IncentiveReward

This guide provides an incentive of FDA. Drugs for peadiatric once they receive a marketing authorisation in USA, they benifit additional 6 months of market exclusivity regardless patent expiration. This incentive is to encourage the development of drugs for children to prevent from other competitors selling similar drugs for similar diseases.

View this resource Bookmark this resource

Market exclusivity in orphan medicines in USA

Published by FDA

Market ExclusivityOrphan IncentivePaediatric Incentive

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.

View this resource Bookmark this resource