Wyeth launches generic version of PROTONIX

Jan 31 2008

Wyeth and its business partner, Nycomed, have announced the U.S. launch of Wyeth's own generic version of PROTONIX tablets, in response to the at-risk launch of generic pantoprazole tablets in the U.S. by Teva Pharmaceuticals USA, Inc. on December 21, 2007.

Wyeth's own generic version of PROTONIX will be distributed by Prasco starting today.

"Compound patents, like that infringed by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in bringing important new medicines to patients," says Bernard Poussot, President and Chief Executive Officer for Wyeth. "We believe the PROTONIX compound patent is strong and we will vigorously pursue our litigation against Teva and other infringing generics. Going forward, we will continue to seek an injunction against any infringement of this patent, as well as monetary damages, including lost profits, from Teva."

Wyeth and Altana Pharma AG (recently acquired by Nycomed) sued Teva and Sun Pharmaceuticals for patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications (ANDAs) seeking U.S. Food and Drug Administration (FDA) approval to market generic versions of PROTONIX before the patent expires on July 19, 2010. Under the Hatch-Waxman Act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until August 2, 2007, and Sun's ANDA until September 8, 2007. On September 6, 2007, The United States District Court for the District of New Jersey denied Wyeth's and Nycomed's motion for preliminary injunction. The Court did not rule on the validity of the patent, but rather concluded that, based on the limited record before it, Wyeth and Nycomed were not entitled to the extraordinary relief of a preliminary injunction. Trial is expected in the second half of 2008.