CRED 8 Presentations

03/07/2024

Data Exclusivity

• Data exclusivity guarantees additional market protection for originator • Health Authorities cannot accept application for generics during the period of exclusivity • Patents can expire before or after drug approval or in between • Exclusivity is granted only upon approval • The effective period of market exclusivity gained by the originator is the period of data exclusivity (8 years) • Data Exclusivity was introduced in 1987 to compensate for insufficient product patent protection in some countries. However, strong product patents are now available in all EU Member States. The rules on data exclusivity were changed in the new EU pharmaceutical laws (8+2+1)

The Organisation for Professionals in Regulatory Affairs

27

8+2+1 data exclusivity

The Organisation for Professionals in Regulatory Affairs

28

14