Ironwood Pharmaceuticals Inc. and Allergan PLC reached a settlement agreement with Princeton, N.J.-based Sandoz Inc., granting the company a license to market a generic version of their constipation drug in the U.S.
Linzess is indicated for treating irritable bowel syndrome with constipation or chronic idiopathic constipation.
Under the settlement deal, the companies allowed Sandoz to market its 145-microgram and 290-microgram doses of its generic version of Linzess, or linaclotide, from Feb. 5, 2030, provided it receives approval from the U.S. Food and Drug Administration. A patent infringement case was brought on by the two companies after Sandoz filed an abbreviated new drug application seeking approval to market the generic in the U.S. before the expiration of related patents.
As a result of the settlement, the patent case will be dismissed. However, Allergan and Ironwood will need to submit the settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for review, according to a Jan. 6 news release.
Additional details of the settlement were not disclosed.
This is the fourth such settlement that partners Ironwood and Allergan have reached with respect to Linzess.
The first settlement was with Sun Pharmaceutical Industries Ltd. for a launch in January 2018 for a future launch of February 2031, while the second was reached with Aurobindo Pharma Ltd. in May 2018 for a future launch in August 2030. The third settlement was reached with Mylan NV in January 2019, for the company's generic to be marketable by February 2030.
Cambridge, Mass.-based Ironwood and Dublin's Allergan are still fighting another patent infringement case in the U.S. District Court for the District of Delaware with Teva Pharmaceutical Industries Ltd., seeking approval to market its generic version of Linzess. The trial, which was scheduled to begin Jan. 7, has been postponed to enable the companies to continue settlement negotiations.