Wockhardt has received tentative approval from the United States Food & Drug Administration (FDA) for marketing the 0.4 mg capsules of tamsulosin hydrochloride, which is used for treating Benign Prostatic Hyperplasia (BPH or non-cancerous enlargement of prostate). Tamsulosin is the generic name for the brand Flomax, marketed in the United States by Boehringer Ingelheim. The patent on this product will expire on April 27, 2010 and Wockhardt will launch the product immediately thereafter.
"Wockhardt has focused on developing products like tamsulosin, which involves complex modified-release technologies to gain competitive advantage," said Wockhardt chairman Habil Khorakiwala. "This is our third NDDS product approval in the year and establishes our competency in such technologies. Both the API and the capsules require special manufacturing facilities and we are geared to meet the market demand," he further added.
According to IMS, the total market for tamsulosin capsules in the US is about $1,650 million and is one of the most used drugs to treat BPH. Prostate enlargement is a common condition afflicting many men above a certain age and with the growing population of the elderly in the US, the demand will continue to increase.
In the US generic pharmaceutical market, Wockhardt has been consistently growing market shares for all its products. Like in the case of tamsulosin, it has been the endeavour of Wockhardt to be amongst the first-to-market companies for its new products.
The tamsulosin capsules will be manufactured at the US FDA certified formulation plant at Chikalthana, Aurangabad and it will use API, which is also being manufactured by Wockhardt in its FDA approved plant. Both the API and 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.