Data exclusivity for medicinal products in Europe
Why is data exclusivity granted?
So what is the impact of a product enjoying "data exclusivity"?
An extra year of protection for new indications
- During the first 8 years from the grant of the innovator company's marketing authorisation, data exclusivity applies.
- After the 8 years have expired a generic company can make use of the pre-clinical and clinical trial data of the originator in their regulatory applications, but still cannot market their product.
- After a period of 10 years from the grant of the innovator company's marketing authorisation, the generic company can also market their product, unless the innovator product qualifies for a further one year of exclusivity.
- This additional 1 year may be obtained in a number of circumstances, such as where the innovator company is granted a marketing authorisation for a significant new indication for the relevant medicinal product. In such a situation the generic company can only market their product after 11 years from the grant of the innovator company's marketing authorisation.
Generic applications in the EU, patents and exclusivity
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