Benzinga | May 26, 2021 04:02PM EDT

Ironwood Pharmaceuticals Announces Agreement with Teva Involving LINZESS 72 mcg Dosage Strength

Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD), announced today that, with its partner AbbVie Inc., the companies have reached an agreement with Teva Pharmaceuticals USA, Inc. providing a license to Teva's abbreviated new drug application (ANDA) seeking approval to market a generic version of 72 mcg LINZESS(r) (linaclotide) prior to the expiration of the companies' applicable patents. With this agreement, the companies have settled with the filers of all known ANDAs to date seeking approval to market generic versions of LINZESS.

Pursuant to the terms of the agreement, Teva will be granted a license to market its 72 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. Previously, Ironwood and Allergan granted Teva a license to market its 145 mcg and 290 mcg generic versions of LINZESS in the United States beginning on the same date. That grant was in connection with a settlement resolving all previous Hatch-Waxman litigation between the companies and Teva regarding LINZESS patents pending in the U.S. District Court for the District of Delaware. Additional details regarding the settlements were not disclosed.

"With this license agreement, we have now preserved the majority of LINZESS patent coverage for all three dosage strengths, reaffirming our commitment to grow the LINZESS franchise for many years to come," stated Tom McCourt, president and interim chief executive officer of Ironwood.

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.