Swedish pharma company Meda Pharmaceuticals (MEDAA: Stockholm) and Indian drugmaker Cipla (BSE: 500087) today have sued Canada-headquartered generics firm Apotex Inc and Apotex Corp in the US Federal District Court in Delaware to enforce the Orange-Book listed patents covering Dymista (azelastine HCl/fluticasone propionate) Nasal Spray.
The action has been taken in response to Apotex' submission to the US Food and Drug Administration of an Abbreviated New Drug Application, and accompanying Paragraph IV certification, seeking approval to market a generic version of Meda’s Dymista prior to expiration of the Dymista patents.
Jörg-Thomas Dierks, Meda chief executive, said: “Meda will vigorously enforce the Dymista patent rights against Apotex and any other company who challenges these patents.”
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