Enalapril is one of the largest-selling cardiac drugs in the world with global sales of $2.5 billion and US sales of over $900 million. It is the invention of US drug major Merck & Co.
Wockhardt's generic equivalent of the drug enters the market just the day after original patent holder Merck & Co's patent lapses on its branded drug Vasotec.
According to patent regulations in the US, companies other than patent holders can launch drugs only after the 20-year patent on the innovation has expired.
It is a common practise for a host of generic companies to launch their products the day the patent lapses. Indian companies are relatively recent entrants to this market cashing in on their reverse engineering skills and cost advantage.
Wockhardt's product, a generic equivalent of the brand Vasotec, has been made available in American drug stores from August 23.
Wockhardt's product is being manufactured and packaged at its manufacturing unit in Aurangabad approved by the US Food and Drug Administration. Wockhardt has received approvals for both the tablets and the bulk drug. This is the second generic formulation after ranitidine that is being marketed by Wockhardt through the joint venture in the American market. Ranitidine, an anti-ulcerant, was earlier patented to Glaxo Wellcome.
Enalapril belongs to the category of Angiotensin Converting Enzyme Inhibitors and is used in the treatment of hypertension and congestive cardiac failure.
"Our arrangement with Sidmak is unique because it offers wide visibility to the Wockhardt brand on one hand and also allows us an equal share in the profits made in the US market on the other," said Habil Khorakiwala, chairman and managing director, Wockhardt.
The two have an agreement to market 15 of Wockhardt's formulations.
Wockhardt has a total of 19 applications for bulk drugs and formulations filed or approved by the US Food and Drugs Administration.
Other companies that are tapping the American generic market include Cheminor Drugs (now merged with Dr Reddy's Laboratories), Ranbaxy Laboratories and Sun Pharmaceuticals.
