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16 Jul 2016

Can patent expire before drug approval?

Yes, absolutely. Patents can be expired before drug approval, issued after drug approval, and anywhere in between.
Exclusivity is granted upon approval of a drug product if the statutory requirements are met.
Some drugs have both patent and exclusivity protection while others have just one or none.
Patents and exclusivity may or may not run concurrently and may or may not encompass the same claims.
Exclusivity is not added to the patent life.
Royed International Drug Regulatory Affairs course

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