Ranbaxy Laboratories will soon join the select club of Indian pharmaceutical majors and have a share in the $76.6 million generics market for anti-infective Cefprozil tablets in the US.
The company has received the US Food and Drug Administration approval to manufacture and market Cefprozil tablets of 250 mg and 500 mg and intends to launch the product in early 2007.
"Ranbaxy is pleased to be granted approval for Cefprozil tablets, which represent yet another addition to our ever-growing product portfolio of anti-infectives that will be available as an affordable generic alternative to the brand equivalent.
"This formulation will be produced in our CGMP-compliant, cephalosporin-dedicated facility located in Dewas, India. Our plans are to bring this product to the market in early 2007 during the height of the respiratory season," according to Jim Meehan, vice-president of sales and marketing for RPI, USA.
Ranbaxy's entry is set to further heat up the competition for the generics market share of Cefprozil products.
Lupin and Orchid Chemicals and Pharmaceuticals are among the early Indian generic players that received marketing approval for Cefprozil tablets of 250 mg and 200 mg a year ago.
The world's largest generic player, Teva Pharmaceutical Industries, had also launched its Cefprozil versions last year.
Meanwhile, the total annual market sales of the drug have declined from $117 million at the time of patent expiry to $76.6 million (IMS-MAT September 2006).
The generic entry was possible after the Office of Generic Drugs, US Food and Drug Administration, determined the generic formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Cefzil tablets of 250 mg and 500 mg of Bristol Myers Squibb Company Pharmaceutical Research Institute.
Cefprozil tablets are indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated micro-organisms in certain conditions, including pharyngitis/tonsillitis, otitis media, acute sinusitis, secondary bacterial infection of acute bronchitis and acute bacterial exacerbation of chronic bronchitis and uncomplicated skin and skin-structure infections.
