Ironwood Pharmaceuticals and Allergan ave reached an agreement with Aurobindo Pharma, resolving patent litigation brought in response to Aurobindo Pharma’s abbreviated new drug application (ANDA) seeking approval to market a generic version of Lizness (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 Lizness.
Pursuant to the terms of the settlement, Ironwood and Allergan will grant Aurobindo Pharma a license to market a generic version of Lizness 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 Lizness patents will be dismissed. Additional details regarding the settlement were not disclosed.
“Lizness 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 VP 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 Lizness remain pending in the U.S. District Court for the District of Delaware, where the earliest scheduled trial date is June 17, 2019.