Wockhardt has received tentative approval from the 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 Forest Laboratories. The patent covering this product is under litigation in the US courts.
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. 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.
Habil Khorakiwala, chairman, 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 US FDA certified formulation plant at Waluj, Aurangabad. The tablets were developed in-house. Wockhardt is one of the few companies with end-to-end integrated capabilities for its products, starting with manufacture of the oral and sterile API’s, the dose forms and marketing through the wholly-owned subsidiary in the US, enabling the company to capture maximum value.