Meda settles Astelin patent case with Cobalt

Sweden's Meda, through its wholly-owned US subsidiary, Meda Pharmaceuticals, has entered into a settlement agreement with Cobalt Pharmaceuticals that resolves the patent litigation between the companies regarding Cobalt's proposed generic version of Astelin (azelastine HCl) nasal spray, used for treatment of allergic and non-allergic rhinitis. The product is protected in the USA by a patent that expires on November 1, 2010, with pediatric exclusivity extending until May 1, 2011.

The accord resolves the patent infringement action filed by Meda after Cobalt's submission of an Abbreviated New Drug Application to the Food and Drug Administration for a generic version of Astelin in July 2007. Under the terms of the deal, Cobalt admits infringement of Meda's patent. The settlement allows Cobalt to launch a generic version of Astelin, under a license from Meda, on August 28, 2010, at the earliest, for which the US firm will pay 32.5% of its net sales of this product to Meda until February 1, 2011.

"With this settlement agreement, Meda has no further patent litigations pending in the USA for Astelin," said Anders Lonner, chief executive of Meda. In compliance with US law, the accord will be submitted to both the Federal Trade Commission and Department of Justice and is subject to their reviews.