Pharmaceutical and biotechnology major Wockhardt Limited has received US FDA's tentative approval for anti-epilepsy drug 'divalproex sodium' delayed release tablets, making it the company's first product incorporating novel drug delivery system (NDDS) to be cleared for sale in the US.
Divalproex sodium is the generic version of Abbott''s Depakote DR tablets.
The patent for divalproex sodium expires on Janaury 29, 2008. Wockhardt's US subsidiary Wockhardt USA Inc. will launch it on the first day of patent expiration in the US market. The market for the product in the US is valued at $802 million, as per IMS data.
Wockhardt currently markets 13 products in the US market. "Approval for an NDDS product by the US FDA is a tribute to the technical skills of our research and regulatory teams," Wockhardt chairman Habil Khorakiwala said. "Our US business is on the fast growth track - this is our third US FDA approval in three weeks and the fifth this year. We have 20 more products awaiting US FDA approval," he said.
Divalproex Sodium will be manufactured at the API (active pharmaceutical ingredient) facility at Ankleshwar and the tablets will be manufactured at the formulation plant in Aurangabad, both certified by US FDA. The process for the API and the tablet were developed through in-house research.
Wockhardt is one of the few companies with end-to-end integrated capabilities for this technology-intensive product, starting with manufacture of API, formulation and marketing. Its new drug discovery programme has yielded several promising new molecules, one of which has entered Phase II human clinical trials. The US and the EU contribute to half of Wockhardt's sales.