Par Pharma acquires Handa's ANDA for generic Dexilant
This article was originally published in Scrip
Par Pharmaceutical has entered into an exclusive acquisition and licence agreement with Handa Pharmaceuticals to acquire Handa's ANDA for dexlansoprazole capsules delayed release, the generic version of Takeda's proton pump inhibitor Dexilant. However, the ANDA is yet to receive final approval from the US FDA. Dexilant is marketed as a treatment for gastro-oesophageal reflux disease (GORD) and healing of erosive esophagitis, in 30mg and 60mg form.
Handa believes it is the first to file an ANDA with the US FDA containing a paragraph IV certification for the 60mg strength of the product, claiming the patents are either invalid or unenforceable. Challenging the patent could potentially provide 180 days of marketing exclusivity. Handa is currently in patent litigation with the brand holder in a US district court; Par will assume control of the ongoing litigation. According to IMS Health, annual sales in the US for the 60mg strength of the product are about $517 million.
Under the agreement, Par made a payment to Handa in return for exclusive rights to market the capsules in the US under the ANDA, subject to FDA approval. Par will receive a percentage of profits from sales of the product.