Watson gets approval for morphine drug, but faces Novartis legal challenge

Watson Pharmaceuticals (NYSE:WPI) got approval from the U.S. Food and Drug Administration for its abbreviated new drug application for morphine sulfate extended-release capsules, the generic version of Actavis‘ Kadian, according to a statement from the company.

The drug manages moderate to severe prolonged pain. For the year ending Sept. 30, Kadian had about $275 million in sales, according to data from IMS Health.

But Watson’s subsidiary, Watson Laboratories, faces a legal challenge from Novartis (NYSE:NVS) after Watson filed an ANDA with the FDA to market rivastigmine transdermal system patches, a generic version of Novartis’ Exelon patch. The patch is used to treat mild to moderate dementia associated with Alzheimer’s and Parkinson’s diseases.

Novartis filed the lawsuit Nov. 9 in U.S. District Court for the District of Delaware in an attempt to prevent Watson from commercializing its product prior to the expiration of two patents in the U.S. The drug company succeeded in getting a stay of final FDA approval of Watson’s ANDA for up to 30 months from the date that Novartis received notice of the ANDA filing, or until resolution of the matter in court, whichever comes first.

The Parsippany, New Jersey drug company said it may be the “first applicant” to file an ANDA for the patch, according to the press release. If so, it may be entitled to 180 days of generic market exclusivity. According to IMS Health, the Exelon patch had sales of $424 million in the 12 months to the end of September.

Watson managed to stave off another legal battle after the U.S. Court of Appeals for the Federal Circuit affirmed a district court’s June 16 denial of Duramed Pharmaceuticals request for a preliminary injunction to prevent Watson from selling a generic version of Seasonique, a birth control tablet launched by Watson in July.

The drug company is gearing up to launch its generic version of Lipitor this month, its biggest drug launch to date.