Meda has settled the patent infringement case against Apotex on Azelastine (4-[(4-chlorophenyl)methyl]-2- (1-methylazepan-4-yl)-phthalazin-1-one). Azelastine is an antihistamine and mast cell stabilizer available as a nasal spray (Astelin®) for hay fever and as eye drops (Optivar®) for allergic conjunctivitis. The following patent is listed in orange book for Optivar (azelastine opthalmic solution) and Astelin (azelastine Nasal spray)
US5164594 (Expiry: May 1, 2011) which covers a method for the treatment of irritation or disorders of the nose and eye which comprises applying directly to nasal tissues or to the conjunctival sac of the eyes a medicament which contains a member selected from the group consisting of azelastine and its physiologically acceptable salts.
As reported earlier by ippharmdoc that litigation is another way for negotiating licensing fees with innovator, this settlement is on similar grounds. The settlement treaty allows Apotex to launch a generic version of Astelin, under a license from Meda, on 1 March 2010. In such case, Apotex will pay 32.5% of their net sales of this product to Meda until 1 February 2011. The agreement also allows Apotex to launch a generic version of Optivar, under license from Meda, on 1 December 2009, without further payments to Meda.
The innovator Meda is in litigation with Sun pharma on Optivar and with Cobalt on Astelin
