Wyeth and its business partner Nycomed, has announced that the United States District Court for the District of New Jersey has taken the matter of Wyeth and Nycomed's motion for a preliminary injunction against Teva Pharmaceuticals USA, Inc. and Sun Pharmaceuticals Inc. in regard to a potential launch of a generic version of ProtonixÒ (pantoprazole sodium) under advisement.
The Court obtained a commitment from both Teva and Sun not to launch any potential generic version of pantoprazole before September 7, 2007 while it considers the matter.
Wyeth and Altana Pharma AG (recently acquired by Nycomed) sued Teva and Sun for patent infringement based on Teva's and Sun's filing of Abbreviated New Drug Applications (ANDA) seeking US Food and Drug Administration (FDA) approval to market generic versions of Protonix before the patent for pantoprazole, the active ingredient in Protonix, 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. In anticipation of the end of those stays, Wyeth and Nycomed filed a motion for preliminary injunction to stop any potential launch.
Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.