Mitsubishi Tanabe Sues Lupin to Block Generic ALS Treatment

Lupin Pharmaceuticals Inc.'s proposed generic version of an orphan drug to treat ALS infringes five patents owned by Mitsubishi Tanabe Pharma Corp., a federal lawsuit says.

Mitsubishi Tanabe alleges Lupin’s copy infringes five patents covering Radicava ORS, according to a complaint filed Monday in the US District Court for the District of Delaware. Radicava ORS helps slow the progression of ALS in patients and was granted orphan drug exclusivity by the US Food and Drug Administration because it “constitutes a major contribution to patient care” for ALS patients, Mitsubishi Tanabe said.

Lupin didn’t immediately respond to Bloomberg Law’s request ...