Global pharma major Takeda Pharmaceutical has filed a patent infringement suit against India's second-largest drug maker Dr Reddy's in a New York Court over the latter's efforts to manufacture a generic version of acid reflux treatment drug Dexilant (Dexlansoprazole).
According to a filing to New York Court, Takeda alleged that the Indian generic-drug maker and its US subsidiary Dr Reddy's Laboratories Inc have infringed US Patent Numbers through the submission of an abbreviated new drug application seeking approval to market generic versions of Dexilent, a patented drug of Takeda.
When contacted, Dr Reddy's official spokesperson offered no comments.
Dexilant is used to treat gastroesophageal reflux disease (GERD), a condition in which stomach acid backflows (refluxes) into the esophagus, causing heartburn and possible injury to the esophagus.
According to Takeda, the two patents which it alleged Dr Reddy's infringed would expire in June 2020 and August 2026.
Takeda, which got the approval from the US FAD to market Dexlansoprazole, changed its name to Dexilent from the earlier Kapidex in March 2010.
Takeda further said it got a mandatory notice from Dr Reddy's on February 21 about their Dexlansoprazole ANDA filing which contained a Paragraph IV certification, a legal assertion that the patents covering Dexilant are invalid.
Takeda requested the court to refrain it from manufacturing, sale and distribution and import of the drug.
According to reports, US sales of Dexilant delayed-release capsules, 30 mg and 60 mg were about $20 million and $261 million, respectively, for the 12 months ending January 2011.
