Wyeth, Nycomed File for Injunction to Block Generic Protonix Launch

Wyeth and Nycomed announced that the U.S. District Court for the District of New Jersey has taken their motion for a preliminary injunction against Teva Pharmaceuticals and Sun Pharmaceuticals under advisement.

The court has obtained a commitment from Teva and Sun that they will not launch generic Protonix (pantoprazole sodium) before Sept. 7 while it considers the matter, the companies said. 

Wyeth and Altana, which was acquired by Nycomed, filed a patent infringement suit against Teva in 2004 and one against Sun a year later in response to the companies’ filing of abbreviated new drug applications (ANDAs) seeking approval to market generic Protonix. The cases have been consolidated.

The filing of the lawsuits initiated a stay of FDA approval for Teva’s ANDA until Aug. 2 and for Sun’s ANDA until Sept. 8, Wyeth and Nycomed said.

A Wyeth spokesman said a judge is expected to issue a ruling before Sept. 7, and the company is confident in its case.