Meda settles Astelin patent litigation

Meda has entered into a settlement agreement with Cobalt Pharmaceuticals resolving the patent litigation between the firms regarding Astelin (azelastine hydrochloride nasal spray).

It has resolved the US patent litigation regarding a proposed launch of a generic formulation of the compound by Cobalt.

The company notes its product is patent protected in the US until the start of November 2010, with its exclusivity for paediatric uses extending until May 2011.

Astelin is used as a treatment for allergic and non-allergic rhinitis.

Cobalt has admitted an infringement of Meda’s patent following its submission of an abbreviated new drug application to the US Food and Drug Administration for a generic version of Astelin in July 2007.

According to the terms of the settlement, Cobalt will be able to launch a generic version of Astelin under a license from Meda on August 28th 2010 and will pay 32.5 per cent of net sales to Meda until February 2011.

Anders Lonner, chief executive officer of Meda, said: “With this settlement agreement, Meda has no further patent litigations pending in the US for Astelin.”

In June 2008, the FDA asked Meda for further details on Astelin prior to its possible approval of the drug as a treatment for allergic reactions.