Sun Pharmaceutical Industries’ wholly owned subsidiaries (collectively Sun Pharma) has reached an agreement with Ironwood Pharmaceuticals, Inc. and Allergan plc (together known as the Companies) to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Linzess (Linaclotide capsules) in the US.
Pursuant to the terms of the settlement, the companies will grant, the wholly owned subsidiaries of Sun Pharma, a license to market a generic version of Linzess in the United States beginning February 1, 2031 (subject to USFDA approval) or earlier under certain circumstances. As a result of the settlement, all Hatch-Waxman litigation between Sun Pharma and the Companies, regarding the Linzess patents, will be dismissed. The agreement is subject to customary regulatory approvals.
Sun Pharmaceutical Industries is the world’s fourth largest specialty generic pharmaceutical company and India’s top pharmaceutical company.
