Innovator Meda has settled the patent infringement case against generic player Cobalt on Azelastine (4-[(4-chlorophenyl)methyl]-2- (1-methylazepan-4-yl)-phthalazin-1-one). Both companies were in litigation since July 2007, after Cobalt submitted ANDA. 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.
Under the settlement agreement, Cobalt admitted infringement of Meda's ‘594 patent. The settlement agreement allows Cobalt to launch a generic version of Astelin, under a license from Meda, on 28 August 2010 at the earliest. Importantly, Cobalt will pay 32.5% of their net sales of this product to Meda until 1 February 2011.
Earlier, innovator settled with Apotex on same product as reported earlier by IP Pharma doc here
Under the settlement agreement, Cobalt admitted infringement of Meda's ‘594 patent. The settlement agreement allows Cobalt to launch a generic version of Astelin, under a license from Meda, on 28 August 2010 at the earliest. Importantly, Cobalt will pay 32.5% of their net sales of this product to Meda until 1 February 2011.
Earlier, innovator settled with Apotex on same product as reported earlier by IP Pharma doc here
However, litigation is pending with Sun pharma on Optivar.
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