FDAnews Drug Daily Bulletin

Teva and Dr. Reddy’s have settled a patent case involving the active pharmaceutical ingredient in GlaxoSmithKline’s (GSK) heart drug Coreg.

The suit was one of several Teva filed beginning in June 2007 to protect its ’997, ’184, ’942 and ’008 patents relating to Coreg’s active ingredient carvedilol. Teva also sued Ranbaxy Laboratories, Watson Pharmaceuticals, Lupin, Orchid Chemical & Pharmaceuticals, Cadila Pharmaceuticals and others in the U.S. District Court for the District of New Jersey.

The defendants in the cases had either received tentative approval from the FDA to market generic Coreg or submitted drug master files indicating they planned to supply carvedilol, according to Teva’s complaint.

Teva said it had tried in a May 8 request to get information on the composition and processes the companies intend to use, but they did not provide the information or samples Teva requested.

As a result, Teva asked the court to declare that its patents were valid and would be infringed on by the products. It also requested a permanent injunction against the companies to prevent them from supplying carvedilol.

The court dismissed the case against Dr. Reddy’s without costs and without prejudice, and it may be reopened within 60 days if the settlement is not carried out, according to court documents.