Replies to post #125388 on Biotech Values

[biomaven0]

longest time between a company's first filing for a generic approval and when they actually got it?

Well it must have been about 5 years for Momenta itself.

Peter

[DewDiligence]

If you’re referring to the ANDA pathway, specifically, the record (as far as I know) is 59 months for NVS/MNTA’s approval of Lovenox. The Cenestin/Premarin application took longer, but Cenestin was ultimately approved under 505b2 and there was a gap in the middle of the timeline between the rejection of the ANDA and the submission of the 505b2 application.