Watson files for approval of generic painkiller
PARSIPPANY, N.J. — Watson Pharmaceuticals is looking to become the first to market a generic version of a painkiller made by Pfizer, the drug maker said Friday.
Watson said it filed a regulatory approval application with the Food and Drug Administration for morphine sulfate and naltrexone hydrochloride extended-release capsules in the 30-mg/1.2-mg, 50-mg/2-mg, 60-mg/2.4-mg, 80-mg/3.2-mg and 100-mg/4-mg strengths. The drug is a generic version of Embeda, made by Pfizer subsidiary King Pharmaceuticals.
Pfizer, King and Alpharma Pharmaceuticals filed a patent infringement suit against Watson Thursday, alleging that Watson's product violates three patents covering Embeda. Filed under the provisions of the Hatch-Waxman Act of 1984 — the law that created an abbreviated approval pathway for generic pharmaceuticals — the suit puts a stay of final FDA approval of the drug for 30 months, or until the companies settle.
Embeda had sales of about $42 million during the 12-month period ended in August, according to IMS Health.