Ironwood Pharmaceuticals and Allergan have entered an agreement with Mylan Pharmaceuticals to settle patent litigations over generic versions of Linzess (linaclotide) medicine.
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist marketed by Ironwood and Allergan in the US under the brand name Linzess to treat irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) in adults.
The litigation was initiated in response to Mylan’s abbreviated new drug applications (ANDAs) filing before the expiration of Ironwood and Allergan’s applicable patents.
Under the terms of the settlement agreement, Mylan gains a licence from Ironwood and Allergan to market a generic version of 145mcg and 290mcg Linzess in the US from 5 February 2030.
The generic of 72mcg dosage of the drug could be marketed in the country from 5 August 2030.
Ironwood Pharmaceuticals in a statement said: “As a result of the settlement, all ongoing Hatch-Waxman litigations between the companies and Mylan regarding Linzess patents pending in the US District Court for the Northern District of West Virginia will be dismissed.”
This settlement is the third Linzess patent infringement settlement reached between Ironwood and Allergan. In January last year, the companies signed an agreement with Sun Pharmaceutical Industries’ wholly owned subsidiaries to resolve a similar litigation.
Additional litigations related to ANDAs for generic versions of the drug are pending in the US District Court for the District of Delaware.
Besides the US, linaclotide is marketed in Europe as Constella for adults with moderate to severe IBS-C.
Ironwood’s partner Astellas markets Linzess to treat adults with IBS-C in Japan. Ironwood further collaborated with AstraZeneca to develop and commercialise linaclotide in China, Hong Kong and Macau.
Ironwood and Allergan are responsible for development and commercialisation activities of the drug in all other global territories.