Ironwood and Allergan Announce Settlement with Aurobindo Pharma Resolving LINZESS® Patent Litigation
CAMBRIDGE, Mass. & DUBLIN–(BUSINESS WIRE)–
Ironwood Pharmaceuticals, Inc. (IRWD) and Allergan plc (AGN) announced today that the companies have reached an agreement with Aurobindo Pharma Ltd., resolving patent litigation brought in response to Aurobindo 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. The settlement with Aurobindo is the second patent infringement settlement the companies have reached with respect to LINZESS.
Pursuant to the terms of the settlement, Ironwood and Allergan will grant Aurobindo Pharma a license to market a generic version of LINZESS in the United States beginning on August 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, all ongoing Hatch-Waxman litigation between the companies and Aurobindo Pharma regarding LINZESS patents will be dismissed. Additional details regarding the settlement were not disclosed.
“LINZESS is the leading branded treatment prescribed in the U.S. for adult sufferers of irritable bowel syndrome with constipation or chronic idiopathic constipation, with more than 10 million prescriptions filled,” said Bill Meury, Executive Vice President and Chief Commercial Officer, Allergan. “We are pleased to have resolved the patent litigation with Aurobindo Pharma. Allergan and Ironwood continue to invest in the LINZESS franchise and to be confident in the product’s market leadership.”
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.
Linaclotide 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), with greater than 2 million unique patients in the United States having filled approximately 10 million linaclotide prescriptions since launch, according to IQVIA. In Europe, Allergan markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood’s partner Astellas markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C. Ironwood also has partnered with AstraZeneca for development and commercialization of linaclotide in China, Hong Kong and Macau, and with Allergan for development and commercialization of linaclotide in all other territories worldwide.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (IRWD) is a commercial biotechnology company focused on creating medicines that make a difference for patients, building value for our fellow shareholders, and empowering our passionate team. We are commercializing two innovative primary care products: linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), and lesinurad, which is approved to be taken with a xanthine oxidase inhibitor (XOI), or as a fixed-dose combination with allopurinol, for the treatment of hyperuricemia associated with gout. We are also advancing a pipeline of innovative product candidates in areas of significant unmet need, including uncontrolled gastroesophageal reflux disease, diabetic nephropathy, heart failure with preserved ejection fraction, achalasia and sickle cell disease. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. For more information, please visit www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.