December 26, 2013
Handa Pharmaceuticals, LLC (“Handa”), a specialty pharmaceutical company based in Fremont, California, today announced that the U.S. Food and Drug Administration (“FDA”) has granted tentative approval of the Abbreviated New Drug Application (“ANDA”) for Dexlansoprazole Delayed Release Capsules, 60 mg, a generic version of Takeda’s DEXILANT®, which Handa transferred to Par Pharmaceutical, Inc. in 2012. Based upon available information, Handa believes that it was the first applicant to file an ANDA for DEXILANT® 60 mg. containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Upon the ANDA receiving final approval from the FDA, Handa believes that the 60 mg. strength of the product will be entitled to 180 days of marketing exclusivity.
“Working with the Par team to receive tentative approval for Dexlansoprazole represents a significant milestone for the product and for Handa as a company,” said Bill Liu, Handa’s President and CEO. “We are very pleased with the outcome.”
According to IMS Health, annual sales of DEXILANT® 60 mg. in the U.S. were about $854 million for the twelve months ended December 31, 2013.
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 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.
Stephen D. Cary
Executive Vice President and COO
Handa Pharmaceuticals, LLC