WOODCLIFF LAKE, N.J. – Par Pharmaceutical Cos. has bought rights to a generic version of a drug used to treat bipolar disorder and schizophrenia.
Par said it bought marketing and distribution rights to generic quetiapine fumarate extended-release tablets from Handa Pharmaceuticals, acquiring Handa's regulatory approval application for the drug. The deal gives Par the right to market, sell and distribute the drug after it receives approval from the Food and Drug Administration and receive a share of the profits. Par itself has a license to market the drug starting in November 2016, under a deal with AstraZeneca.
The drug is a generic version of AstraZeneca's Seroquel XR, and Handa considers itself the first company to file a complete application for the generic drug in the 50-mg, 150-mg, 200-mg and 300-mg strengths. If it is, then the drug will have 180 days in which to compete directly with AstraZeneca's product, according to generic drug regulations.
Seroquel XR has annual sales of about $808 million, according to IMS Health.