Par Pharmaceutical, Inc. has entered into an exclusive acquisition and license agreement with Handa Pharmaceuticals, LLC to acquire Handa’s Abbreviated New Drug Application (ANDA) for quetiapine fumarate extended-release tablets, the generic version of AstraZeneca’s Seroquel XR.  

Handa believes it is the first applicant to file an ANDA containing a paragraph IV certification for the 50 mg, 150 mg, 200 mg and 300 mg strengths of the product, which would potentially provide 180 days of marketing exclusivity.  

According to IMS Health data, annual US sales for these strengths of Seroquel XR are approximately $808 million.  The ANDA also includes a 400 mg dosage strength.

Under the terms of the agreement, Par has made a payment for the ANDA and for exclusive rights to market, sell and distribute quetiapine fumarate extended-release tablets in the US under the ANDA, subject to its final approval by the US Food and Drug Administration.  Par will receive a share of profits from the sales of the product.  Under the terms of a prior settlement agreement with AstraZeneca, which has been assigned to Par, Par has a license to enter the US market with quetiapine fumarate extended-release tablets on November 1, 2016 or earlier under certain circumstances.

Par Pharmaceutical Companies, Inc. is a privately held, U.S.-based specialty pharmaceutical company.  Through its wholly-owned subsidiary’s two operating divisions, Par Pharmaceutical and Strativa Pharmaceuticals, it develops, manufactures and markets high barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals.