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Takeda Pharma files patent infringement suit against Dr Reddys

PTI | 09:04 PM,Apr 12,2011

Hyderabad, Apr 12 (PTI) Global pharma major Takeda Pharmaceutical Co has filed a patent infringement suit against India�s second largest drug maker Dr Reddy�s Laboratories in a New York Court over the latter�s efforts to manufacture a generic version of acid reflux treatment drug Dexilant (Dexlansoprazole). 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. 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 USD20 million and USD261 million, respectively, for the 12 months ending January 2011. When contacted, an official spokesperson of Dr Reddy�s offered no comments.


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