Chain Drug Review - Wyeth to sell generic Protonix
MADISON, N.J. — Wyeth and its business partner, Nycomed, have launched a generic version of the former’s Protonix tablets.
Wyeth says it took the action in response to the December 21 “at risk” launch of generic pantoprazole tablets in the United States by Teva Pharmaceuticals USA. Wyeth’s generic version of Protonix is being distributed by Prasco Laboratories.
“Compound patents, like that infringed upon by Teva, represent the foundation of pharmaceutical innovation, a critical underpinning in banging important new medicines to patients,” says Wyeth president and chief executive officer Bernard Poussot. “We believe the Protonix compound patent is strong, and we will vigorously pursue our litigation against Teva and other infringing generics.”
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Wyeth and Altana Pharma AG (recently acquired by Nycomed) sued Teva and Sun Pharmaceuticals Ltd. for patent infringement based on Teva’s and Sun’s filing of abbreviated new drug applications seeking Food and Drug Administration approval to market generic versions of Protonix before the patent expires on July 19, 2010.
On September 6, 2007, a federal district court in New Jersey denied Wyeth’s and Nycomed’s motion for a preliminary injunction. According to Wyeth, the court did not rule on the validity of the patent, but rather concluded that, based on the 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.
“We are pleased to have established this agreement with Wyeth,” comments Prasco CEO E. Thomas Arington, noting that the company is distributing 20-and 40-mg versions of the product, used to treat heartburn.
Teva responds that it has not relaunched and does not intend to ship additional units of its generic “at this time.”
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