Par Pharma acquires Handa's ANDA for generic Dexilant

USA-based Par Pharmaceutical (NYSE: PRX) has entered into an exclusive acquisition and license agreement with Handa Pharmaceuticals to acquire its Abbreviated New Drug Application for dexlansoprazole capsules, the generic version of Takeda's gastro-intestinal drug Dexilant.

Handa believes it is the first to file an ANDA containing a paragraph IV certification for the 60mg strength of the product, which would potentially provide 180 days of marketing exclusivity. According to IMS Health data, annual sales in the USA for this dosage of Dexilant are around $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 USA under the ANDA, subject to final Food and Drug Administration approval. Par will receive a percentage of profits from the sales of the product. No further financial terms were disclosed.