Meda settles U.S. Astelin patent litigation with Cobalt

Aug 25 2008

Meda, through its wholly owned U.S. subsidiary, Meda Pharmaceuticals Inc., has entered into a settlement agreement with Cobalt Pharmaceuticals Inc. (hereafter Cobalt) that resolves the U.S. patent litigation between the companies regarding Cobalt's proposed generic version of Astelin.

Astelin (azelastine hydrochloride nasal spray) is used for treatment of allergic and non-allergic rhinitis. The product is protected in the U.S. by a patent that expires on 1 November 2010, with paediatric exclusivity extending until 1 May 2011.

The settlement agreement resolves the patent infringement action filed by Meda after Cobalt's submission of an ANDA (Abbreviated New Drug Applications) to the U.S. FDA (Food & Drug Administration) for a generic version of Astelin in July 2007. Under the settlement agreement, Cobalt admits infringement of Meda's 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. In such case, Cobalt will pay 32.5% of their net sales of this product to Meda until 1 February 2011.

"With this settlement agreement, Meda has no further patent litigations pending in the U.S. for Astelin", said Anders Lönner, CEO Meda.

In compliance with U.S. law, the settlement agreement will be submitted to the U.S. Federal Trade Commission and Department of Justice and is subject to their review.