Sun Pharmaceutical Industries’ wholly owned subsidiaries have reached an agreement with Ironwood Pharmaceuticals and Allergan to resolve the patent litigation associated with the submission of an abbreviated new drug application (ANDA) for generic Linzess (linaclotide) in the US.
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that locally binds to the GC-C receptor in the intestinal epithelium. The drug is currently marketed by Ironwood and Allergan in the US and various other markets.
The litigation was filed as Sun Pharma submitted the ANDA before the expiration of Ironwood and Allergan’s patents.
Under the settlement, Ironwood and Allergan will grant Sun Pharma’s wholly owned subsidiaries with a licence to market Linzess’ generic version in the US from 1 February 2031 or earlier under certain circumstances, subject to FDA approval.
Following the settlement, all ligation between the firms with respect to Linzess patents will be dismissed.
Ironwood Pharmaceuticals chief commercial officer Tom McCourt 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.”
Additional patent infringement litigations brought by Ironwood and Allergan over Linzess ANDAs submitted by other firms to the FDA are yet to be resolved.