Wockhardt has received tentative approval from the FDA for marketing the 5mg and 10mg tablets of Memantine HCI, 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 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 $1.1b and is the first of Alzheimer’s drugs that block NMDA glutamate receptors.
Habil Khorakiwala, chairman of Wockhardt, said: “Wockhardt was amongst the first-to-file for an ANDA with paragraph IV certification on Memantine and is one of the first-to-get a tentative approval. 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.”
The Memantine tablets will be manufactured at the FDA certified formulation plant at Waluj, Aurangabad, India.