Momenta Pharmaceuticals, Inc. (MNTA)

[DewDiligence]

does [thrice-weekly generic Copaxone] have an NDA target date?

No—MNTA’s application is an ANDA (not an NDA).

does the patent case affect the FDA decision?

Yes, insofar as the FDA is bound by the 30-month stay under Hatch-Waxman; i.e., until 1/28/17, FDA approval of MNTA’s ANDA for thrice-weekly Copaxone would be tentative rather than final (see link in #msg-116497178).

Starting on 1/28/17, FDA may grant a final approval for MNTA’s Copaxone ANDA (or convert a prior tentative approval to a final approval). Hence, NVS/MNTA could conceivably launch thrice-weekly generic Copaxone “at risk” less than a year from now.