– Settlement with Teva represents final outstanding LINZESS patent litigation –
– The earliest licensed entry of any generic linaclotide 145 mcg or 290 mcg in the U.S. is March 2029 –
BOSTON & DUBLIN--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) and Allergan plc (NYSE:AGN) announced today that the companies have reached an agreement with Teva Pharmaceuticals, USA (Teva) resolving patent litigation brought in response to Teva’s abbreviated new drug application (ANDA) seeking approval to market generic versions of 145 mcg and 290 mcg LINZESS (linaclotide) prior to the expiration of the companies’ applicable patents. This settlement with Teva is the last of the remaining defendants in this patent infringement litigation with respect to LINZESS. This settlement does not grant any license to Teva with regard to its 72 mcg generic version of LINZESS.
Pursuant to the terms of the settlement, Ironwood and Allergan will grant Teva a license to market its 145 mcg and 290 mcg generic version of LINZESS in the United States beginning March 31, 2029 (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 Teva regarding LINZESS patents pending in the U.S. District Court for the District of Delaware was dismissed. Additional details regarding the settlement were not disclosed.
“This latest ANDA settlement with Teva reinforces our belief in the strength of the LINZESS intellectual property, having preserved the majority of LINZESS patent coverage for the 145 mcg and 290 mcg dosage forms,” stated Mark Mallon, Chief Executive Officer of Ironwood Pharmaceuticals. “LINZESS is an important treatment option for the millions of Americans living with IBS-C or CIC and we look forward to working with our partner to continue 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.
Previously, upon the parties’ request, the District of Delaware dismissed without prejudice the pending patent infringement litigations relating only to Teva’s 72 mcg generic version of LINZESS. Ironwood and Allergan had asserted patents against Teva’s 72 mcg ANDA, the last of which expires in 2026, subject to possible pediatric extension. Prior to this dismissal, Teva stipulated to infringement of certain claims of those patents. Ironwood and Allergan are also pursuing additional patent applications covering formulations related to the LINZESS 72 mcg dosage strength.