Tuesday, 15 September 2009

Memantine hydrochloride (Namenda) 5 mg and 10 mg tablets: 4 generic players exit patent litigation

The chief judge honorable G.M. Sleet of U.S. District Court for the District of Delaware has signed off on a request to dismiss M/S Upsher-Smith Lab (and 3 other generic players) from a patent infringement lawsuit that innovator Forest Labs and Merz Pharma brought to thwart the generic challenge to the Alzheimer's drug Memantine (Namenda) hydrochloride 5 mg and 10 mg tablets.


Innovator has listed following patent in Orange Book for Memantine hydrochloride 5 mg and 10 mg tablets:


US5061703 (Expiry: April 11, 2015): covers a method for the prevention or treatment of cerebral ischemia comprising the step of administering, to a patient in need thereof, an effective amount of Memantine.


The various generic players filed ANDA with para 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.


As per court’s order, M/S Upsher-Smith Lab (and 3 other generic players) can not launch generic version till expiry of ‘703 patent.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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