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Monday, March 8, 2010

Wockhardt : US FDA approval for Alzheimer’s drug Memantine

Wockhardt06 Jan,2010 - Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food & Drug Administration (US FDA) for marketing the 5mg and 10mg tablets of Memantine HCl, which is used for treatment of moderate to severe Alzheimer’s disease and dementia. Memantine is the generic name for the brand Namenda, marketed in the United States by Forrest Laboratories. The patent covering this product is under litigation in the US courts. Wockhardt and Forrest 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. According to IMS, 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... Wockhardt's Press Release -