Meda Pharmaceuticals and Cipla have sued Apotex in Federal District Court in Delaware to enforce the Orange-Book listed patents covering Dymista (azelastine HCl/fluticasone propionate) Nasal Spray in response to Apotex’s submission to the US Food and Drug Administration (“FDA”) of an Abbreviated New Drug Application (“ANDA”), and accompanying Paragraph IV certification, seeking approval to market a generic version of Meda’s Dymista prior to expiration of the Dymista patents.
The Complaint was filed within 45 days of receiving Apotex’s Paragraph IV certification notice, thus triggering an automatic stay preventing the FDA from approving Apotex’s ANDA for 30 months from receipt of the notice, unless ordered otherwise by a district court. Meda has the exclusive licenses to U.S. Patent Nos. 8,163,723 and 8,168,620 covering the Dymista composition and its approved uses, which does not expire until 2026. Meda holds the New Drug Application (“NDA”) to manufacture and market Dymista in the US for the treatment of seasonal allergic rhinitis.
“Meda will vigorously enforce the Dymista patent rights against Apotex and any other company who challenges these patents”, said Dr. Jörg-Thomas Dierks, CEO of Meda.