Supplier News Breaks Archives
Par Pharma buys rights for Dexilant generic
April 19th, 2012
WOODCLIFF LAKE, N.J. – Par Pharmaceutical Cos. has agreed to acquire the U.S. rights to market and distribute a generic version of Dexilant, an antacid.
The company said Thursday that its Par Pharmaceutical Inc. subsidiary has entered into an exclusive acquisition and license agreement with Handa Pharmaceuticals LLC to acquire Handa's abbreviated new drug application (ANDA) for dexlansoprazole capsules, the generic version of Takeda's Dexilant.
According to Par, Handa believes it's 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.
Under the deal, Par made a payment to Handa for the ANDA, giving it the exclusive rights to market, sell and distribute dexlansoprazole capsules in the United States under the ANDA, subject to final Food and Drug Administration 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, reported Par, which will assume control of ongoing litigation.
A proton pump inhibitor, dexlansoprazole decreases stomach acid and is used to treat heartburn caused by gastroesophageal reflux disease (GERD), as well as to heal erosive esophagitis.
According to IMS Health data cited by Par, annual U.S. sales for the 60-mg strength of Dexilant are approximately $517 million.