October 29, 2012
Handa Pharmaceuticals, LLC (“Handa”), a specialty pharmaceutical company based in Fremont, California, today announced that it has entered into an exclusive acquisition and license agreement with Par Pharmaceutical, Inc. for 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 U.S. sales for these strengths of Seroquel XR® are approximately $808 million. The ANDA also includes the 400 mg dosage strength.
Under the terms of the agreement, Handa has received a payment from Par for the ANDA, giving Par the exclusive rights to market, sell and distribute quetiapine fumarate extended-release tablets in the U.S. under the ANDA, subject to its final approval by the U.S. Food and Drug Administration. Handa will receive a percentage of profits from the sales of the product. Under the terms of a settlement agreement with AstraZeneca, Par has been assigned a license to enter the U.S. market with quetiapine fumarate extended-release tablets on November 1, 2016 or earlier under certain circumstances.
About Handa Pharmaceuticals, LLC
Handa Pharmaceuticals, LLC is a specialty pharmaceutical company that was established in the San Francisco Bay area in November 2005. Handa’s executive leadership has a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. For more information, please visit http://www.handapharma.com.
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Handa’s current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Handa disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Handa’s current expectations depending upon a number of factors affecting Handa’s business. These factors include, among others, patents and other intellectual property rights held by competitors and other third parties and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and demand for Handa’s products; difficulties or delays in manufacturing; and other risks and uncertainties.
SEROQUEL® and SEROQUEL XR® are registered trademarks of the AstraZeneca group of companies.