Wockhardt launches anti-hypertension drug Nicardipine injections in the US
18 November 2009
Pharmaceutical and biotechnology major Wockhardt has received final approval from the United States Food and Drug Administration (US FDA) for marketing the 25mg/10 ml injection of its hypertension drug Nicardipine HCl.
Nicacdipine, which is used for short-term management of hypertension or increased blood pressure, is the generic name for the brand `Cardene,' which is in the US by EKR Therapeutics, Wockhardt said in a release.
Wockhardt is launching the product immediately after the expiry of the patents covering this product on 17 November 2009.
"The injections and other sterile products form an integral part of Wockhardt's growth strategy in the United States," said Wockhardt chairman Habil Khorakiwala. "This is our seventeenth sterile product approval in the US based on a variety of technologies like liquid injections in vials and pre-filled syringes, powder for injection and ophthalmic solutions. Being backward integrated into the Nicardipine API will also help us gain competitive advantage," he added.
The total market for Nicardipine injection in the US is over $200 million and is one of the few drugs that are used in injectable form to control hypertension in patients who are unable to receive oral medications, according to IMS.
Wockhardt said it would manufacture Nicardipine injections at the US FDA-certified formulation plant at Waluj, Aurangabad, using API, which is also being manufactured by Wockhardt in its FDA-approved plant at Ankleshwar. Both the API and the injections were developed in-house, it added.
Wockhardt has end-to-end integrated production capabilities, starting with manufacture of the oral and sterile APIs, the dose forms and marketing through the wholly-owned subsidiary in the US.
Wockhardt said it has consistently been growing market shares for all its products in the US market and, by virtue of being amongst the first to market, will gain advantages of being an early entrant in the hypertension treatment market.