Meda Pharmaceuticals and Cipla have filed suit against Apotex in the Delaware Federal District Court, claiming that Apotex’s submission of an ANDA for a generic version of Dymista azelastine HCl/fluticasone propionate nasal spray violates patents related to Dymista that will not expire until 2026.
Meda holds the licenses to US patents 8,163,723 and 8,168,620 8,168,620 (“Combination of azelastine and steroids”), both originally assigned to Cipla. Dymista was approved for the treatment of allergic rhinitis in the US in May 2012 and in the EU in January 2013. Cipla continues to supply the azelastine for the nasal spray.
Meda CEO Jörg-Thomas Dierks said, “Meda will vigorously enforce the Dymista patent rights against Apotex and any other company who challenges these patents.”
Read the Meda and Cipla press release.
