October 3, 2011
Handa Pharmaceuticals, LLC (“Handa”), a specialty pharmaceutical company based in Fremont, California, today announced that it has reached an agreement with AstraZeneca to settle its U.S. patent litigation regarding Handa’s Abbreviated New Drug Application (“ANDA”) for Quetiapine Fumarate Extended-Release Tablets 50 mg., 150 mg., 200 mg., 300 mg., and 400 mg., a generic version of AstraZeneca’s SEROQUEL XR®. Handa is the first applicant to file an ANDA for SEROQUEL XR® 50 mg., 150 mg., 200 mg., and 300 mg. containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act.
Under the terms of the settlement agreement, AstraZeneca has granted Handa a license to enter the U.S. market with a generic version of SEROQUEL XR® on November 1, 2016 or earlier upon certain circumstances. Handa and AstraZeneca have filed a proposed Consent Judgment with the U.S. District Court for the District of New Jersey requesting that the Court dismiss the pending legal action between Handa and AstraZeneca.
“We are pleased to resolve Handa’s patent litigation with AstraZeneca on our First-to-File ANDA for Quetiapine XR. This settlement agreement allows Handa to bring a generic version of SEROQUEL XR® to the U.S. market prior to the November 2017 expiration of AstraZeneca’s formulation patent, without incurring the uncertainty and risk inherent with patent litigation,” said Bill Liu, Handa’s President and CEO.
According to IMS Health, annual sales of SEROQUEL XR® in the U.S. were about $883 million for the twelve months ended March 31, 2011.
About Handa Pharmaceuticals, LLC
Handa Pharmaceuticals, LLC is a specialty pharmaceutical company with a proven track record of developing controlled-release prescription pharmaceutical products that are difficult to formulate. In March 2011, Handa announced that its ANDA for Dexlansoprazole Delayed Release Capsules 60 mg., a generic version of Takeda’s DEXILANT®, had been accepted for review by the U.S. Food and Drug Administration (“FDA”). Based upon available information, Handa believes that it is the first applicant to file an ANDA for DEXILANT® 60 mg. containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Should its ANDA for Dexlansoprazole Delayed Release Capsules 60 mg. be approved by the FDA, Handa believes that the product may be entitled to 180 days of generic market exclusivity. For more information, please visit 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.
DEXILANT® is a registered trademark of Takeda Pharmaceuticals North America, Inc.
Stephen D. Cary
Executive Vice President and COO
Handa Pharmaceuticals, LLC