Wockhardt gets US FDA approval for Alzheimer's drug Memantine

Pharmaceutical and biotechnology major Wockhardt has received tentative approval from the United States Food and 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 US by Forrest Laboratories. The patent covering this product is under litigation in the US courts.

Wockhardt and Forrest Laboratories, however, 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, the company said in a press release.

Memantine tablets in the US has a market of about $1.1 billion, the release said quoting IMS. Memantine is also the first in a novel class of Alzheimer's drugs that block NMDA glutamate receptors, it added.

"Wockhardt was amongst the first to file for an abbriviated new drug application (ANDA) for Memantine and is one of the first to get a tentative approval," Wockhardt chairman Habil Khorakiwala said. "This is also one of several other products that Wockhardt has `first-to-file' ANDA status and such filings are a critical growth factor in the highly competitive US generic market," he added.

Wockhardt has been consistently growing market shares for all its products in the US generic pharmaceutical market, the release said. In many instances, Wockhardt, by virtue of being amongst the first to market, will gain advantages of being an early entrant, it added.

Wockhardt said the Memantine tablets, developed in-house, will be manufactured at the US FDA certified formulation plant at Waluj, Aurangabad.

Wockhardt, an end-to-end integrated pharmaceuticals company, will market for its products through its wholly-owned subsidiary in the US.