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Wockhardt gets tentative approval for Alzheimer’s generic memantine (Namenda) in US

Thursday, January 7, 2010, 19:35 This news item was posted in Industry category and has 0 Comments so far.

India’s Wockhardt has received tentative approval generic memantine for treatment of Alzheimer’s disease from US FDA.

Wockhardt received conditional marketing approvals the 5mg and 10mg tablets of memantine HCl, Wockhardt said in a press release.

Wockhardt’s memantine is a therapeutic equivalent of the brand Namenda, marketed in the United States by Forest Laboratories.

Memantine is used for treatment of moderate to severe Alzheimer’s disease and dementia.

Forest’s patents covering Namenda (memantine) is under litigation in the US courts.

The total market for memantine tablets in the US is about $1.1 billion and is the first in a novel class of Alzheimer’s drugs that block NMDA glutamate receptors, according to IMS Health.

Wockhardt will manufacture memantine tablets at the US FDA certified formulation plant at Waluj, Aurangabad, the release said.

Wockhardt and Forest Laboratories have reached a settlement on their patent litigation, which will allow Wockhardt to launch its generic version several months ahead of patent expiration or as soon as any other generic version is launched.

Forest Labs has been suing several generic companies, including firms from India, alleging that their abbreviated new drug applications (ANDA) under Para IV were infringing its patent on memantine (Namenda).

In January 2008, Forest Laboratories and its partner Merz Pharma filed several lawsuits against  generic firms including Lupin Ltd, Orchid Chemicals & Pharmaceuticals Ltd and Wockhardt Ltd,  Cobalt Laboratories, Teva Pharmaceuticals, Upsher-Smith Laboratories, Ranbaxy, Mylan and Barr Laboratories in the U.S. District Court for the District of Delaware as these companies tried to obtain marketing approval for memantine (Namenda).

US Patent ‘709 owned by Forest Labs and assigned to Germany-based Merz Pharma GmbH & Co. KGaA, covers formulations of adamantane derivatives that were manufactured and marketed as Namenda.

Forest has licensed the ’703 patent from Merz.

In October, Indian generic firm sun Pharma settled a patent infringement lawsuit Alzheimer’s medication memantine (Namenda) with Forest Laboratories.

The District of Delaware, US has signed off on a stipulation and order resolving the patent dispute between Sun India Pharmaceuticals and Forest Laboratories, Inc. over alleged infringement of U.S. Patent No. 5,061,703 (’703).

Sun Pharma, which has been denying that the company had violated Forest’s patent ‘703 through filing ANDA to market a generic version of memantine (Namenda), has retreated from this position in the stipulation.

Sun Pharma has admitted in the stipulation that the company’s filing of generic application for memantine (Namenda) with US FDA constituted a “technical act of infringement,” reports said.

In addition, Sun Pharma agreed that it will not market or manufacture 5-milligram or 10-milligram tablets during the life of the ‘703 patent unless all asserted claims of the patent have been found to be invalid.

Forest’s ‘703 patent on adamantane (Namenda) is set to expire in April 2010.

Forest said it also has applied for a patent extension that would prolong the life of the patent through September 2013.

The District Court’s order dismissed without prejudice all claims and counterclaims in the case.

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