Singapore - Sun Pharmaceutical Industries, India’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 a generic version of Linzess capsules in the US.
Linzess capsules are 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.
Post the settlement, the patent infringement litigation initiated by Ironwood and Allergan against Sun Pharma will be dismissed. Additional details regarding the settlement were not disclosed.
The companies will submit the settlement agreement to the US Federal Trade Commission and the US Department of Justice for review.
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.
