Replies to post #111194 on Biotech Values

[zipjet]

Actually, NVS/MNTA’s Copaxone ANDA becomes actionable in about three weeks, when the Hatch-Waxman 30-month stay expires. From that point on, the FDA can issue a final approval for the ANDA, not just a tentative approval.

Are there examples where FDA approved a generic while the patent litigation continued?

ij

[DewDiligence]

Addendum on expiration of 30-month clock for generic Copaxone: The Hatch-Waxman 30-month clock (during which time the FDA cannot issue a final approval of NVS/MNTA’s Copaxone ANDA) started on 7/11/08 when NVS/MNTA notified Teva of their Paragraph-IV certification for Copaxone (http://www.tevapharm.com/pr/2008/pr_771.asp ). The clock thus expires on January 11, 2011.

After 1/11/11, the FDA can issue a final approval of the Copaxone ANDA whenever the FDA sees fit, without any regard for the status of the Copaxone patent litigation.