FDAnews Drug Daily Bulletin

A federal appeals court has approved Novartis’ motion to prohibit Teva Pharmaceutical Industries temporarily from selling its generic version of the antiviral drug Famvir in the U.S., Novartis announced last week.

The order, issued Sept. 7 by the U.S. Court of Appeals for the Federal Circuit, required Teva to submit a response by Sept. 11. The injunction remains in effect until a final court decision, Teva said.

Teva announced Aug. 24 that it received final approval to market generic Famvir (famciclovir) tablets but said it would not launch the product until after a Sept. 5 hearing in the U.S. District Court for the District of New Jersey regarding Novartis’ motion for a preliminary injunction. The court denied the motion, and Novartis submitted a notice of appeal Sept. 6, according to court records.

Teva announced the launch of its generic Famvir Sept. 7, noting that as the first company to file an abbreviated new drug application (ANDA) containing a Paragraph IV certification for the drug, it has been awarded 180 days of marketing exclusivity.

Novartis said its Famvir patent protection doesn’t expire until 2015 and Teva’s at-risk launch could result in significant damages if Novartis prevails in litigation.

Famvir, which is indicated for treating herpes, had U.S. sales of approximately $200 million during the 12-month period that ended in June, according to Teva.