Spring Intro 2023

16/02/2023

Market Exclusivity – Determines Launch Date

“Market Exclusivity” Determines When A Generic Can Be Launched

Article 10(1), Directive 2001/83/EC: …A generic medicinal product authorised pursuant to this provision shall not be placed on the market until ten years have elapsed from the initial authorisation of the reference product. …

• Prevents generic launches for a further 2 years following expiry of DE • Can be extended by an extra year for a new therapeutic indication that is of significant clinical benefit if added during the first 8 years.

The Organisation for Professionals in Regulatory Affairs

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Summary – Data And Market Exclusivity

Generic launches possible*

Generic applications possible

Reference product approval

2 yrs +1 yr*

8 yrs

Market Exclusivity*

Data Exclusivity

*By default reference products get a 2 year period of Market Exclusivity but they can get an extra 1 year if a new indication of “significant clinical benefit in comparison with existing therapies” is added during the first 8 years.

The Organisation for Professionals in Regulatory Affairs

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