Sun Pharma reaches agreement with us based ironwood and allergan over patent.

On Tuesday Indian’s largest drug maker said it has reached an agreement with US based Ironwood Pharmaceuticals and Allergan Plc. to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for generic version of Linzess Capsules in the US. A capsule prescribed to relieve symptoms of irritable bowel syndrome (IBS) and Chronic idiopathic constipation (CIC) in adults.

As per the terms of the settlement, Sun Pharma said it will get a license to launch a generic of Linzess in US starting February 1, 2031, or earlier under certain circumstances, subject to US FDA approval. While post settlement, the patent infringement litigation initiated by Ironweed and Allergan against Sun Pharma will be dismissed with additional details regarding the settlement were not disclosed. However the companies will submit the settlement agreement to the US Federal Trade Commission and the US Department of Justice for review. Tom McCourt, Chief Commercial Officer at Ironwood said “Ironwood and Allergan have established Linzess as the branded prescription market leader in the IBS-C and CIC category, we are pleased to have resolved this patent litigation with Sun Pharma, as we believe it confirms the strength of our Linzess intellectual property. Allergan and Ironwood are committed to continuing to grow the Linzess franchise for many years to come.”

More than 1.5 million unique patients in the US have filled 9 million linaclotide prescriptions of the drug since its launch, according to QuintilesIMS. Ironwood expects the sales to touch USD 700 million in the year ended December 2017, accounting for around 75 percent of the company’s total sales.Patent infringement litigation initiated by the companies against other parties who have submitted ANDAs to the US FDA seeking approval to market generic versions of Linzess are pending in the US District Court for the District of Delaware, where the earliest scheduled trial date is June 17, 2019.While announcement came after the market hours but it seen share hiked up on Tuesday0.29% on to close at Rs578.10 on BSE, while the benchmark Sensex declined 0.21% to end 34,771.05 points. Anyway Teva, Mylan, Sandoz and Aurobindo Pharma have also challenged the patents to make generic Linzess capsules, before the expiration of the drug’s patents as per money control.