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Ironwood and Allergan Receive Notices of Allowance for Patent Applications Covering 72 mcg Dose of LINZESS® (linaclotide)
– New patents expected to provide coverage for 72 mcg dose into 2031 – BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced
About this update from Ironwood Pharmaceuticals, Inc.
[{"type":"text","content":"\n– New patents expected to provide coverage for 72 mcg dose into 2031 –\n\n BOSTON--(BUSINESS WIRE)--\nIronwood Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that the United States Patent and Trademark Office (USPTO) has issued Notices of Allowance for patent applications covering the formulation of the 72 mcg dose of LINZESS® (linaclotide) and methods of using the formulation. The patent applications are expected to issue in 2020 and expire in 2031.\n\n\nLINZESS is approved and marketed in the United States for the treatment of adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). It was the first guanylate cyclase-C (GC-C) agonist to be approved by the U.S. Food and Drug Administration.\n\n\n“We believe that this action by the USPTO reinforces the durability of our flagship product LINZESS, the number one prescribed medication for millions of adult patients with IBS-C or CIC,” said Mark Mallon, chief executive officer of Ironwood Pharmaceuticals. “We have been innovating with linaclotide for more than 15 years and believe in the strength of the intellectual property we have developed for LINZESS. In 2020, we remain focused on growing this franchise while working to deliver new therapies to GI patients.”\n\n\nA notice of allowance is a written notification issued after the USPTO makes a determination that a patent is eligible to be granted from an application. The vast majority of patent applications that receive a notice of allowance will proceed to issue as a U.S. patent; however, a notice of allowance is not a guarantee of patent issuance.\n\n\nIronwood and Allergan previously entered into settlement agreements with five generic drug manufacturers (Teva Pharmaceuticals, USA, Sandoz Inc., Aurobindo Pharma Ltd. and an affiliate of Aurobindo, Mylan Pharmaceuticals Inc. and Sun Pharma Global FZE) resolving all outstanding patent infringement litigation brought in response to their abbreviated new drug applications seeking approval to market generic versions of LINZESS prior to the expiration of Ironwood’s and Allergan’s applicable patents. Pursuant to the terms of the settlements, Ironwood and Allergan granted each of the five generic drug manufacturers a license to market their 145 mcg and 290 mcg generic versions of LINZESS, beginning as early as...