Module 6

03/10/2024

Data/market exclusivity

• Regulatory data protection : prevents regulators using data on file for new MAs • Generics/competitors prevented from benefit of abridged procedure for a period of time

The Organisation for Professionals in Regulatory Affairs

Data Exclusivity

45

Data/market exclusivity…The “8+2+1” exclusivity formula

A period of:

•

• 8 years data exclusivity plus

• 2 years market exclusivity equals 10 years in total

• Plus extra protection for new indications:

• 10 year period can be extended to a maximum of 11 years if new indication of significant clinical benefit in comparison with existing therapies is approved within the first 8 years

• Practical consequences for generic applications

• 10 (+2) year market exclusivity for orphan drugs

The Organisation for Professionals in Regulatory Affairs

Data Exclusivity

46

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