Bioequivalence and Bioavailability Forum

Dear Manan,
As to my knowledge, a patent is the exclusive right given to the innovator for 20 years from the date of filing and NDA.
But as research goes on a patent can be challenged withing this period without infringement. Then a exclusivity can move to the one who has challenged it along with the patentee, provided his formulation has been proven better.
Regarding expiry of patents and the future of BA-BE studies, i must say that as NDDS are progressing there is a scope for many new formulations including the existing ones, so many Investigational products for BABE.

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Jaime]