Watson, Mallinckrodt settle over generic painkiller
PARSIPPANY, N.J. — Watson Pharmaceuticals and Mallinckrodt have reached a settlement concerning a painkiller for which the former had sought Food and Drug Administration approval.
Watson announced that one of its subsidiaries had settled with Mallinckrodt over Watson’s generic version of Exalgo (hydromorphone hydrochloride) extended-release tablets. Mallinckrodt, a subsidiary of medical products maker Covidien, filed a patent-infringement suit against Watson in December 2010 in the U.S. District Court for the District of New Jersey after Watson sought FDA approval for a generic version of the drug in the 8-mg, 12-mg and 1- mg strengths.
Under the settlement, Watson gets a royalty-free license to patents related to Exalgo and can launch a generic version in November 2013. Other terms of the settlement were not disclosed. Watson said it was probably the first company to seek approval for a generic version, which would entitle it to 180 days of market exclusivity in which to be the sole competitor to Mallinckrodt’s product.
BioPlus Specialty Pharmacy earns ACHC accreditation
ALTAMONTE SPRINGS, Fla. — A specialty pharmacy chain has earned accreditation from the Accreditation Commission for Health Care.
BioPlus Specialty Pharmacy said ACHC accreditation indicates that the organizational management, internal processes, patient safety practices and service outcomes at BioPlus meet the highest standards.
“Our ACHC accreditation serves as a symbol of excellence and lets patients, providers, and insurance payers know that BioPlus meets the highest level of commitment to quality and accountability,” BioPlus SVP Elvin Montanez said. “We’re proud that yet another accrediting body, ACHC, finds that BioPlus ‘measures up’ as an organization in terms of our performance in administering patient care and service delivery.”
Federal court clears way for Watson, Amphastar to launch generic version of Lovenox
PARSIPPANY, N.J. — A federal court has stopped an injunction that would have prevented drug maker Watson Pharmaceuticals and partner company Amphastar Pharmaceuticals from marketing or selling a generic version of a blood-thinning drug.
The companies announced Thursday that the U.S. Court of Appeals for the Federal Circuit has granted them a stay of the preliminary injunction issued by the U.S. District Court for the District of Massachusetts in October, which Sandoz had sought to prevent Watson and Amphastar from launching a generic version of Sanofi’s Lovenox (enoxaparin sodium). Watson and Amphastar said they plan to launch the drug immediately.
Sandoz, the generics arm of Swiss drug maker Novartis, already markets a generic version of the drug, for which it received Food and Drug Administration approval in July 2010.