Friday 23 July, 2010

to Memantine hydrochloride (Namenda) 5 mg and 10 mg tablets: Mylan announced settlement with innovator

After settlement with generic player Lupin and others, the innovator Forest and Merz Pharma have settled the patent litigation w.r.t method of use patent U.S. Patent No. 5,061,703 (scheduled to expire in April, 2015) with generic player Mylan. Mylan has confirmed in a press release that that it has entered into settlement and license agreements with Forest Laboratories and Merz Pharmaceuticals related to Memantine hydrochloride (Namenda) 5 mg and 10 mg tablets

As per agreement, Mylan will have the right to market Memantine HCl in the U.S. on Jan. 11, 2015, or earlier, under certain circumstances. Additional details of the agreement remain confidential and remain subject to review by the U.S. Department of Justice and the Federal Trade Commission (FTC).

Earlier, the various generic players like Barr Lab, Cobalt Lab, Lupin, Orchid, Teva Pharma, Upsher-Smith Lab, Genpharm, Sun, Ranbaxy and Wockhardt filed ANDA with Paragraph patent IV certification against ‘703 patent. Subsequently, innovator sued various generic players for the infringement of ‘703 patent in U.S. District Court for the District of Delaware.

Importantly, most of the generic players have settled the patent litigation with innovator. The some of generic players like Lupin, Mylan and others will enter almost 3 months prior to patent expiry.

Namenda had U.S. sales of $1.2 billion for the twelve months ending March 31, 2010, according to IMS Health.

Refer to my earlier posts on Namenda http://ippharmdoc.blogspot.com/2009/12/memantine-hydrochloride-namenda-tablets.html

Source: Press release of Mylan (http://investor.mylan.com/releasedetail.cfm?ReleaseID=490915)

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