Hi All,
As per MAPP 5240.3 Rev. 4 Prioritization of the review of Original ANDA's, Amendments and Supplements:
"Submissions that contain a paragraph IV certification but become eligible for
approval during the review period as a result of no blocking patents or
exclusivities (including 180-day exclusivity under section 505(j)(5)(B)(iv) of the
FD&C Act (180-day exclusivity)) and no applicable stays may receive a priority
review if no other generic version of the same RLD has been brought to market
under an approved ANDA. The absence of any blocking patent, exclusivity
period, or stay must be appropriately documented in order for a priority review to
be granted. For 180-day exclusivity, "no exclusivity" means (1) that the 180-day
exclusivity has either been relinquished or waived or (2) that FDA has
determined that a forfeiture of the exclusivity has occurred"
Based on this, is the priority review only given to the First filer and not the subsequent filers?
This MAPP also mentions that:
"Submissions for drug products for which there are not more than three approved
drug products listed in FDA's Approved Drug Products with Therapeutic
Equivalence Evaluations (the "Orange Book")6 and for which there are no
blocking patents or exclusivities listed for the reference listed drug (RLD) may
receive a priority review"
I'm not sure why Priority reviews are given for ANDA's without blocking patents and exclusivity if there are not more than 3 approved drug products listed in Orange book while in the case of Paragraph IV filing only the first filer gets the Priority review.
Any insight into this is appreciated.
Thanks,
Mehul
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Mehul Govani RAC
Regulatory Affairs Manager
Westbury NY
United States
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