Pharma Focus Asia

Ironwood and Allergan Announce Settlement with Mylan Resolving LINZESS® (linaclotide) Patent Litigation

Thursday, January 03, 2019

Ironwood Pharmaceuticals, Inc. and Allergan plc announced today that the companies have reached an agreement with Mylan Pharmaceuticals, Inc. resolving patent litigations brought in response to Mylan’s abbreviated new drug applications (ANDAs) seeking approval to market generic versions of LINZESS (linaclotide) prior to the expiration of the companies’ applicable patents. The settlement with Mylan is the third patent infringement settlement the companies have reached with respect to LINZESS.

Pursuant to the terms of the settlement, Ironwood and Allergan will grant Mylan a license to market its generic version of LINZESS 145 mcg and 290 mcg in the United States beginning February 5, 2030, and its generic version of LINZESS 72 mcg in the United States beginning August 5, 2030 (both 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 litigations between the companies and Mylan regarding LINZESS patents pending in the U.S. District Court for the Northern District of West Virginia 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 litigations brought by Allergan and Ironwood 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.

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