FDAnews Drug Daily Bulletin

German drugmaker Nycomed and Wyeth have filed a lawsuit to prevent Teva from marketing a generic version of the heartburn drug Protonix IV.

Teva notified Nycomed and Wyeth in a letter dated April 25 that it had filed an ANDA for injectable Protonix (pantoprazole sodium) that included a Paragraph IV certification on the ’579 patent, which expires in July 2010. The drug is indicated to treat gastroesophageal reflux disease.

The plaintiffs brought suit against Teva June 11 in the U.S. District Court for the District of New Jersey and have asked the court to enjoin the drugmaker from marketing its generic Protonix IV until the patent expires.

Teva is not the first firm to face a legal action over a proposed generic version of the drug. Nycomed and Wyeth filed suit in May against Sandoz in the U.S. District Court for the Northern District of Illinois after the drugmaker filed an ANDA with a Paragraph IV certification on the ’881 patent, which expires in 2021. 

Nycomed and Wyeth have acted previously to protect the Protonix family. Wyeth launched its own generic Protonix tablets Jan. 29 following Teva’s at-risk launch of generic pantoprazole tablets in the U.S. last December.