Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food & Drug Administration (US FDA) for marketing 37.5mg, 75mg and 150mg extended release capsules of venlafaxine HCl, which is used for treatment of depression and anxiety disorders. Venlafaxine is the generic name for the brand Effexor XR, marketed in the United States by Pfizer. Wockhardt will be launching the product in the US market on June 1, 2011.
According to IMS Health, the total market for this product in the US is about $2.3 billion and is one the most widely used antidepressant drugs. The product is a capsule containing specially designed pellets to extend their release over 24 hours and requires specialized technology and manufacturing capability.
“This is yet another successful demonstration of our capabilities in developing and manufacturing products based on Extended-Release technologies”, said Wockhardt chairman, Dr Habil Khorakiwala. “Our product selection strategies have revolved around maximizing our strengths in this area of pharmaceutical technology and venlafaxine XR bears testimony to the same.”
In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. In many instances, Wockhardt, by virtue of being amongst the first to market, has reaped the advantage of being an early entrant.
The tablets will be manufactured at the US FDA certified formulation plant at Chikalthana, Aurangabad. The capsules 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.