Ironwood and Allergan settle patent dispute with Indian major

Drugmakers Ironwood Pharmaceuticals (Nasdaq: IRWD) and Allergan (NYSE: AGN) have reached an agreement with wholly-owned subsidiaries of India’s Sun Pharmaceutical Industries (BSE: 524715) resolving patent litigation brought in response to Sun Pharma’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Linzess (linaclotide) prior to the expiration of the companies’ applicable patents.

Under the terms of the settlement, Ironwood and Allergan will grant the wholly-owned subsidiaries of Sun Pharma a license to market a generic version of Linzess in the USA beginning on February 1, 2031 (subject to US Food and Drug Administration approval), unless certain limited circumstances, customary for settlement agreements of this nature, occur. As a result of the settlement, all Hatch-Waxman litigation between the companies and Sun Pharma regarding Linzess patents will be dismissed. Additional details regarding the settlement were not disclosed.

Linaclotide is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).Allergan’s third-quarter 2017 sales of Linzess (linaclotide) were $190.9 million, a year-on-year increase of 16.1%.