Rewards and incentives for paediatric medicines in European Union

Published by EMA

RewardPaediatric IncentiveMarket Exclusivity

This guide provides some rewards and incentives to encourage investment in research and development of medicines for children in European Union. E.g Peadiatric medicinces once they receive a marketing authorisation, they benifit additional 6 months of market exclusivity regardless patent expiration. Medicines once approved for children that are not protected by a patent or supplementary protection certificate are eligible for a paediatric-use marketing authorisation (PUMA). If a PUMA is granted, the product will benefit from 10 years of market protection.

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Rewards and incentives for paediatric medicines in USA

Published by FDA

Paediatric IncentiveMarket ExclusivityReward

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.

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How to protect an invention internationally using World Intellectual Property Organization (WIPO) IP Portal??

Published by WIPO

PatentWIPOPCT

This guide helps you understand the PCT and how to submit a patent application worldwide with World Intellectual Property Office (WIPO)

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Market exclusivity in orphan medicines in Europe Union

Published by EMA

Orphan IncentivePaediatric IncentiveMarket ExclusivityIncentive

This guide provides an incentive of EMA. Orphan medicines once they receive a marketing authorisation in EU, they benifit additional 10 years of market exclusivity regardless patent expiration. This incentive is to encourage the development of medicines for rare diseases to prevent from other competitors selling similar medicines for similar diseases. If the orphan medicines are intended for paediatric population, the market exclusivity is extended by two additional years for an orphan designated condition.

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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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