Ironwood Pharmaceuticals and AbbVie grant licence for LINZESS (linaclotide) 72 mcg to Teva
27 May 2021 -

Healthcare company Ironwood Pharmaceuticals Inc (NASDAQ:IRWD) and its partner AbbVie Inc (NYSE:ABBV) announced on Wednesday an agreement with Teva Pharmaceuticals USA Inc providing a licence to Teva's abbreviated new drug application (ANDA) seeking approval to market a generic version of 72 mcg LINZESS (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.

Teva will be granted a licence to market its 72 mcg generic version of LINZESS in the United States beginning 31 March 2029 (subject to US FDA approval), unless certain limited circumstances occur. Previously, Ironwood and Allergan granted Teva a licence 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 US District Court for the District of Delaware. Further details regarding the settlements were not disclosed.

LINZESS is a once-daily capsule that helps relieve the abdominal pain, constipation, and overall abdominal symptoms of bloating, discomfort and pain associated with irritable bowel syndrome with constipation (IBS-C), as well as the constipation, infrequent stools, hard stools, straining and incomplete evacuation associated with chronic idiopathic constipation (CIC).