Biotech Values

[DewDiligence]

But not soft enough to approve [MNTA’s generic Copaxone]

The FDA’s GDUFA regs specify that ANDA reviews be prioritized according to (among other things) the expiration date of the last Orange Book patent for the branded drug. (This wasn’t true before the GDUFA regs came into being). Hence, there’s no pressure on the FDA to approve MNTA’s Copaxone ANDA until near the 5/24/14 expiration date of Teva’s Copaxone patent.