Risperidone: Teva faces opposition for 180 days First to file exclusivity from Apotex

As reported earlier on first to file exclusivity litigation between Teva and FDA over relisting of US5158952 (Teva won recently as per district court decision). Apotex filed a motion to intervene in the Rieperidone generic case to safeguard its substantial interests in the outcome of Teva V/S FDA litigation. Apotex’s ANDA is not yet tentatively approved. (Only Mylan and Pliva have tentative ANDA approvals.) If Judge grants Apotex’s motion, then the company “intends to file a notice of appeal and immediately pursue the appropriate appellate remedies to obtain a stay of the District Court’s ruling pending appeal, and/or review of the ruling on an emergency or expedited basis prior to the June 29, 2008 launch date.” It is pertinent to mention that Teva has opposed the motion from Apotex (For complete review of this case Link to FDAlawblog here)