Ranbaxy Laboratories Ltd, India's largest pharmaceutical company, has managed to garner a 90 per cent market share of the anti-infective drug cefuroxime axetil in the US market with sales exceeding $85 million.
Ranbaxy Pharmaceuticals Inc, the wholly owned subsidiary of Ranbaxy, had received manufacturing and marketing approval from the US Food and Drug Administration for cefuroxime axetil tablets 125 mg (base), 250mg (base) and 500 mg (base) tablets on February 15, 2002. This was the first approval granted to any generic company for this product.
In September 2002, the company's market share of cefuroxime axetil was close to 87 per cent, with sales exceeding $75 million.
Sales from the US subsidiaries during the nine months ended September 30, 2002 increased to $207 million as against $70 million in the corresponding period previous year.
According to pharmaceutical analysts, close to half of the profits for the company in the US market came from cefuroxime axetil.
Cefuroxime Axetil is the bio-equivalent to Ceftin, the original brand of GlaxoSmithKline. Ranbaxy received the FDA approval after a prolonged battle between Ranbaxy and GlaxoSmithKline over the patent issue.
Cefuroxime axetil tablets are indicated for the treatment of patients with infections caused by susceptible strains of designated organisms in the pharyngitis and tonsillitis, lower respiratory tract infections, urinary tract infections and skin infections.
It is the largest selling oral cephalosporin in the US. The combined sales of all three strengths of the branded product is estimated to be in excess of $ 254 million in the retail segment alone.
Ranbaxy will reap the benefits of being the first and only company to receive approval for the generic version of the product till next year. The second generic player, Apotex, is likely enter the US market sometime next year.