FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Allergan, Ironwood and Sun Pharma Reach Deal in Patent Dispute

Jan. 23, 2018

Allergan and Ironwood Pharmaceuticals agreed to a settlement with Sun Pharma, India’s largest drug manufacturer, to resolve a patent dispute over the Indian company’s abbreviated new drug application for a generic version of Linzess (linaclotide) in the U.S.

Linzess, an oligo-peptide agonist, is used in the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation in adults.

The settlement, which will be subject to review by the U.S. Department of Justice and the Federal Trade Commission, will allow wholly-owned subsidiaries of Sun Pharma to seek a license to launch a generic version of Linzess in the U.S. beginning Feb. 1, 2031 — or earlier, in certain circumstances — and end the patent infringement litigation.

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