Sun Pharmaceutical Industries, India’s largest drug maker, on Tuesday 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. “Ironwood and Allergan have established Linzess as the branded prescription market leader in the IBS-C and CIC category,” said Tom McCourt, Chief Commercial Officer at Ironwood.
“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,” McCourt said.
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.
Teva, Mylan, Sandoz and Aurobindo Pharma have also challenged the patents to make generic Linzess capsules, before the expiration of the drug’s patents.
The announcement by Sun Pharma came after market hours. Shares of the company rose 0.29 percent on Tuesday to close at Rs 578.10 on BSE, while the benchmark Sensex declined 0.21 percent to end 34,771.05 points.
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