Handa Pharmaceuticals Announces Submission of Its First-to-File ANDA for Takeda Pharmaceutical Co. Ltd.'s DEXILANT(R)
Published: Mar 02, 2011
FREMONT, Calif., March 2, 2011 /PRNewswire/ -- Handa Pharmaceuticals, LLC ("Handa"), a specialty pharmaceutical company based in Fremont, California, today confirmed that its Abbreviated New Drug Application ("ANDA") for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda's DEXILANT®, has 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® 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.
According to IMS Health, annual sales of DEXILANT® Delayed Release Capsules, 60 mg, in the U.S. were about $300 million for the twelve months ended December 31, 2010.
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. In December 2010, Handa announced that the U.S. Food and Drug Administration ("FDA") had granted tentative approval of the Company'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. 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.
DEXILANT® is a registered trademark of Takeda Pharmaceuticals North America, Inc.
SEROQUEL® and SEROQUEL XR® are registered trademarks of the AstraZeneca group of companies.
Executive Vice President and COO
Handa Pharmaceuticals, LLC
SOURCE Handa Pharmaceuticals, LLC