Ironwood Pharmaceuticals Announces Agreement with Teva Involving LINZESS® (linaclotide) 72 mcg Dosage Strength
Ironwood Pharmaceuticals (NASDAQ: IRWD) announced an agreement with Teva Pharmaceuticals to license a generic version of LINZESS (linaclotide), allowing marketing to begin on March 31, 2029, pending FDA approval. This agreement settles all known ANDA filings for generic LINZESS. The patent coverage for LINZESS is preserved across three dosage strengths, reaffirming the company's plans to grow its franchise. The settlement will be submitted for review to regulatory authorities.
- Settlement with Teva protects LINZESS patent coverage until March 31, 2029.
- Agreement resolves all known ANDA filings for generic LINZESS, reducing competitive risks.
- None.
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® (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.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Under the guidance of our seasoned industry leaders, we continue to build upon our history of GI innovation and challenge what has been done before to shape what the future holds. We keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.
Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts.
We routinely post information that may be important to investors on our website at www.ironwoodpharma.com. In addition, follow us on Twitter and on LinkedIn.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand in the U.S. for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC), based on IQVIA data.
LINZESS is a once-daily capsule that helps relieve the abdominal pain, constipation, and overall abdominal symptoms of bloating, discomfort and pain associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72-mcg dose approved for use in CIC depending on individual patient presentation or tolerability. LINZESS should be taken at least 30 minutes before the first meal of the day.
LINZESS is contraindicated in pediatric patients less than 6 years of age. The safety and effectiveness of LINZESS in pediatric patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of guanylate cyclase-C (GC-C) agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences. In adults with IBS-C or CIC treated with LINZESS, the most commonly reported adverse event was diarrhea.
LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called GC-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established.
In the United States, Ironwood and AbbVie co-develop and co-commer
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