Ironwood Pharmaceuticals and Allergan reach agreement to resolve Mylan LINZESS patent litigation
4 January 2019 -

United States-based Ironwood Pharmaceuticals and Ireland-based Allergan have reached an agreement with Netherlands-based Mylan Pharmaceuticals to resolve patent litigations over Mylan's abbreviated new drug applications seeking approval to market generic versions of LINZESS (linaclotide) before the expiration of their applicable patents, it was reported yesterday.

The settlement with the company is the third patent infringement settlement that the companies have reached with respect to LINZESS.

Based on the terms of the settlement, Ironwood and Allergan will offer Mylan a license to market its generic version of LINZESS 145mcg and 290mcg in the United States starting 5 February 2030, and its generic version of LINZESS 72mcg in the United States starting 5 August 2030 (both subject to US 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 United States District Court for the Northern District of West Virginia will be dismissed. Additional details regarding the settlement were not revealed. As a legal requirement, the companies will submit the settlement agreement to the US Federal Trade Commission and the US Department of Justice for review.