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Ironwood, Allergan allow 2030 launch of Mylan's Linzess generic for constipation

Ironwood Pharmaceuticals Inc. and Allergan plc settled a patent dispute with Mylan NV over the generic maker's version of Linzess, a drug that treats irritable bowel syndrome with constipation.

The deal stipulates that Mylan may launch its generic versions of Linzess in 2030 at different times of the year depending on the size of the dose. Ironwood and Allergan permitted the Canonsburg, Pa. company to market its 145-microgram and 290-microgram doses in February 2030 and its 72-microgram Linzess generic in August of that year. These represent all approved doses of the drug approved in the U.S.

Litigation between the companies regarding the drug will be dismissed. Financial details of the settlement were kept under wraps.

It is the third such settlement that partners Ironwood and Allergan have reached to protect Linzess, also known as linaclotide. The first was with Sun Pharmaceutical Industries Ltd. in January 2018 for a future launch of February 2031. The second settlement was reached with Aurobindo Pharma Ltd. in May 2018 for the company's generic to be marketable by August 2030.

Cambridge, Mass.-based Ironwood and Dublin's Allergan are still fighting patent infringement battles with other companies seeking U.S. Food and Drug Administration approval for generic versions of the drug, including Teva Pharmaceutical Industries Ltd. and Novartis AG's Sandoz, according to documents from the U.S. District Court of the District of Delaware. The earliest trial is scheduled for June 17, 2019.