Par Pharmaceutical Companies, Inc's operating subsidiary Par Pharmaceutical, Inc. 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 US 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 US 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 US District Court for the District of Northern California. Par will assume control of ongoing litigation.
Par Pharmaceutical Companies, Inc. is a US-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.