Ironwood Pharmaceuticals, Inc. and Allergan plc announced they reached an agreement with subsidiaries of Sun Pharmaceutical Industries Ltd. 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.
Tom McCourt, chief commercial officer, Ironwood, said: “Ironwood and Allergan have established Linzess as the branded prescription market leader in the IBS-C (irritable bowel syndrome with constipation) and CIC (chronic idiopathic constipation) category.
“We are pleased to have resolved this patent litigation with Sun Pharma, as we believe it confirms the strength of our Linzess intellectual property.
“Allergan and Ironwood are committed to continuing to grow the Linzess franchise for many years to come.”
Ironwood and Allergan said in a statement: “Pursuant to 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 United States beginning on February 1, 2031 (subject to U.S. FDA 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.”