Business
Ironwood and Allergan Announce Settlement Resolving LINZESS® (linaclotide) Patent Litigation
BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc (NYSE: AGN) announced today that the companies have reached an
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":" BOSTON--(BUSINESS WIRE)--\nIronwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Allergan plc (NYSE: AGN) announced today that the companies have reached an agreement with Sandoz Inc. (Sandoz) resolving patent litigation brought in response to Sandoz’s abbreviated new drug application (ANDA) seeking approval to market generic versions of LINZESS (linaclotide) prior to the expiration of the companies’ applicable patents. The settlement with Sandoz is the fourth patent infringement settlement the companies have reached with respect to LINZESS.\n\n\nPursuant to the terms of the settlement, Ironwood and Allergan will grant Sandoz a license to market its 145 mcg and 290 mcg generic version of LINZESS in the United States beginning February 5, 2030 (subject to U.S. FDA approval), unless certain limited circumstances, customary for settlement agreements of this nature, occur. As a result of the settlement, the ongoing Hatch-Waxman litigation between the companies and Sandoz regarding LINZESS patents pending in the U.S. District Court for the District of Delaware will be dismissed. Additional details regarding the settlement were not disclosed.\n\n\nAs 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.\n\n\nPatent infringement litigation brought by the companies against Teva Pharmaceuticals USA, Inc. and affiliates, which 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. However, the trial that was scheduled to begin on January 7, 2020 has been postponed to enable the parties to continue settlement negotiations.\n\n\nAbout Linaclotide \n\n\nLinaclotide is a guanylate cyclase‐C (GC‐C) agonist that binds to the GC-C receptor locally, within the intestinal epithelium. Linaclotide is marketed by Ironwood and Allergan plc in the United States as LINZESS® and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). In Europe, Allergan markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. Ironwood's partner Astellas markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C i...