Meda resolves patent suits against Apotex

Swedish specialty drugmaker Meda has resolved US patent litigation regarding Canadian generic firm Apotex' proposed versions of its rhinitis nasal spray Astelin (azelastine HCl nasal spray) and Optivar (azelastine HCl) ophthalmic solution for allergic conjunctivitis. These products are protected in the USA by a patent that expires on November 1, 2010, with pediatric exclusivity extending until May 1, 2011.

The settlement agreement resolves infringement actions filed by Meda after Apotex' submission of Abbreviated New Drug Applications to the US Food and Drug Administration for copycat generic versions of Astelin and Optivar in 2006 and 2007, respectively. Under the terms of the settlement, Apotex admits infringement of Meda's patent, and the parties will jointly request that scheduled trials be adjourned and the actions closed. The settlement deal allows Apotex to launch a generic version of Astelin, under license from Meda, on March 1, 2010, with a 32.5% royalty payment until February 1, 2011, as well as a licensed generic version of Optivar on December 1, 2009, without further payments to Meda.