Par Pharmaceutical Acquires Rights to Market and Distribute Generic Dexilant® in the U.S.
Potential for 180 Day Marketing Exclusivity
WOODCLIFF LAKE, N.J., April 19, 2012 /PRNewswire/ -- Par Pharmaceutical Companies, Inc. (NYSE: PRX) today announced that its Par Pharmaceutical, Inc. operating subsidiary has entered into an exclusive acquisition and license agreement with Handa Pharmaceuticals LLC to acquire Handa's ANDA for dexlansoprazole capsules, the generic version of Takeda's Dexilant®. Handa believes it is the first to file an ANDA containing a paragraph IV certification for the 60 mg strength of the product, which would potentially provide 180 days of marketing exclusivity. According to IMS Health data, annual sales in the U.S. for the 60 mg strength of Dexilant are approximately $517 million.
Under the terms of the agreement, Par made a payment to Handa for the ANDA, giving it the exclusive rights to market, sell and distribute dexlansoprazole capsules in the U.S. under the ANDA, subject to final FDA approval. Par will receive a percentage of profits from the sales of the product.
Handa is currently involved in patent litigation concerning dexlansoprazole in the U.S. District Court for the District of Northern California. Par will assume control of ongoing litigation.
About Par Pharmaceutical Companies, Inc.
Par Pharmaceutical Companies, Inc. is a 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 higher-barrier-to-entry generic drugs and niche, innovative proprietary pharmaceuticals. For press releases and other company information, visit www.parpharm.com.
Safe Harbor Statement
Certain statements in this news release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and, as such, are subject to known and unknown risks, uncertainties and contingencies, many of which are beyond the control of the Company, which could cause actual results and outcomes to differ materially from those expressed herein. Risk factors that might affect such forward-looking statements include those set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, in other of the Company's filings with the SEC from time to time, including Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, and on general industry and economic conditions. Any forward-looking statements included in this news release are made as of the date hereof only, based on information available to the Company as of the date hereof, and, subject to any applicable law to the contrary, the Company assumes no obligation to update any forward-looking statements.
SOURCE Par Pharmaceutical Companies, Inc.
More by this Source
Par Pharmaceutical Announces Fourth Quarter and Full Year 2013 Conference Call
Mar 13, 2014, 13:33 ET
Par Pharmaceutical Begins Shipment of Generic Lanoxin®
Jan 16, 2014, 14:03 ET
Par Pharmaceutical Announces Quarterly Conference Call
Nov 05, 2013, 09:03 ET
Browse our custom packages or build your own to meet your unique communications needs.
Learn about PR Newswire services
Request more information about PR Newswire products and services or call us at (888) 776-0942.