Ironwood Pharmaceuticals, Inc. and Allergan plc have reached an agreement with wholly owned 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.
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.
“Ironwood and Allergan have established Linzess as the branded prescription market leader in the IBS-C and CIC category,” said Tom McCourt, chief commercial officer, Ironwood. “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.”
As required by law, the companies will submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
Patent infringement litigations brought by the companies against other parties who have submitted ANDAs to the U.S. FDA seeking approval to market generic versions of Linzess remain pending in the U.S. District Court for the District of Delaware, where the earliest scheduled trial date is June 17, 2019.
(Source: Ironwood Pharmaceuticals, Inc.)
