Ironwood, Allergan reach patient litigation settlement with Sandoz on Linzess

Ironwood Pharmaceuticals and Allergan have reached an agreement with Sandoz resolving patent litigation brought in response to Sandoz’s 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.

Pursuant 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 Feb. 5, 2030 (subject to  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.

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 litigation brought by the companies against Teva and affiliates, which submitted ANDAs to the 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 Jan. 7, 2020 has been postponed to enable the parties to continue settlement negotiations.