Wyeth preliminary injunction motion taken under advisement

Wyeth has announced that its motion for a preliminary injunction against Sun Pharmaceuticals and Teva Pharmaceuticals USA regarding the possible future launch of a generic formulation of Protonix (pantoprazole sodium) has been taken under advisement by a US court.

It reports that the decision from the US Court for the District of New Jersey follows the filing of a lawsuit by Wyeth and Altana Pharma – a firm recently purchased by Nycomed – against Sun and Teva.

This lawsuit is based on those companies’ abbreviated new drug applications requesting US Food and Drug Administration approval for the marketing of a generic form of Protonix ahead of the patente expiration of pantoprazole in July 2010.

“The court obtained a commitment from both Teva and Sun not to launch any potential generic version of pantoprazole before September 7th 2007, while it considers the matter,” Wyeth notes.

Wyeth moved for this preliminary injunction, as under the provisions of the Hatch-Waxman act, the filing of its lawsuit against Sun and Teva delayed an FDA decision on the matter until September 8th 2007 and August 2nd 2007 respectively, with this motion aiming to prevent any potential launch of a generic version of Protonix.

In January 2007, Wyeth reported that decreasing sales of Zoton during the 2006 fiscal year as a result of increased competition from generics was offset by improved sales of a number of other compounds, including Protonix.