Module232025

Patent Exclusivity Benefits for Drugs implementing Pediatric Development include:

1.Extended Market Protection : Additional 6-month exclusivity under pediatric exclusivity programs delays generic competition, enabling revenue generation. 2.Increased Profitability : Encourages investment in pediatric studies by offsetting research costs with prolonged exclusivity. 3.Enhanced Innovation : Supports development of age-appropriate formulations, fostering therapeutic advances for pediatric patients. 4.Regulatory Incentives : Collaboration with EMA/FDA programs (e.g., Pediatric Use Marketing Authorization - PUMA) offers guidance and exclusivity benefits for addressing unmet pediatric needs.

https://www.abpi.org.uk/international-trade-and-ip/intellectual-property-ip/intellectual-property-enabling-next-generation-innovation/

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs