Wockhardt Receives Tentative Approval for Memantine HCl Tablets from US FDA

Strategic Insights -

The Indian pharma major Wockhardt has made significant strides in the treatment of Alzheimer's disease and dementia, receiving tentative approval from the US Food & Drug Administration (US FDA) to market its version of Memantine HCl tablets. This development comes as a result of Wockhardt's settlement with Forrest Laboratories over patent litigation, allowing the company to launch its generic version ahead of schedule. Wockhardt's Memantine HCl tablets will be used to treat moderate to severe stages of the diseases, marking a significant milestone in the company's efforts to bring affordable healthcare solutions to patients.

Key Takeaways:

  • Wockhardt has received tentative approval from the US FDA to market 5mg and 10mg tablets of Memantine HCl, used to treat moderate to severe stages of Alzheimer's disease and dementia.
  • The company has reached a settlement with Forrest Laboratories over patent litigation, allowing it to launch its generic version of Memantine HCl several months ahead of the patent expiration.
  • The total market for Memantine tablets in the US is approximately US$1.1 billion, according to IMS, a market analyst firm.
  • Wockhardt was the first-to-file for an ANDA with paragraph IV certification on Memantine and is the first to receive a tentative approval from the US FDA.
  • The company's Memantine tablets will be manufactured at its US FDA certified formulation plant at Waluj in Aurangabad.
  • Wockhardt Chairman Habil Khorakiwala stated that the company's version of Memantine HCl tablets will be developed in-house.

Statistics:

  • The US market for Memantine tablets is approximately US$1.1 billion (IMS).
  • Wockhardt's Memantine HCl tablets will be manufactured at its US FDA certified formulation plant at Waluj in Aurangabad.
  • The company believes that its generic version of Memantine HCl can be launched several months ahead of the patent expiration, thanks to the settlement with Forrest Laboratories.

Sources:

  • Wockhardt (BSE:532300) statement on tentative approval from US FDA (no date).
  • Asia Pulse, "Wockhardt gets FDA nod for Alzheimer's drug" (no date).
  • PTI, "Wockhardt gets US FDA nod for Alzheimer's drug" (no date).
  • IMS market analysis (no date mentioned in the original text).