The Indian generic drug manufacturer Ranbaxy Laboratories Ltd faces no threat from the US FDA approved Apotex Inc's cefuroxime axetil. The Canadian generic pharmaceutical manufacturer, Apotex, received its approval for cefuroxime axetil on October 4, 2002.
According to an analyst source, Ranbaxy, which got the first approval for the generic in February 2002, launched it in March 2002, and thus enjoyed a monopoly over the generic sales, sees no threat of Apotex launching its generic before another 8-10 months.
Ranbaxy has recorded a formulation export of the generic to the tune of US$ 37 million sales till June'02 and is said to be holding over 55% of the market share of the product. It has reportedly priced the product at a 30 per cent discount to the GSK brand Ceftin. Ceftin, the GSK brand, has an annual sales of $ 265 million. Generic Ceftin is the main export profit driver for Ranbaxy and is expected to remain so for another three quarters.
Apotex had lost a case against GSK in June'2002 and had appealed to the US Federal Circuit (FC). Even a preliminary injunction will take at least 8-10 months to be cleared. GSK's patent on amorphous product expires in June'03. Hence the court decision will more or less coincide with the patent expiry.
According to the source, Ranbaxy believes that there is little chance of Apotex launching the product on winning this approval from US FDA as the Canadian company has lost the case in the lower court. Should the company go ahead with the launch now, it would suffer damages of upto three times the lost sales of the GSK brand if Apotex loses its case at the FC.
Hence analysts do not expect Apotex to launch its generic cefuroxime till 2Q 2003. This means there is very little threat to Ranbaxy.
Apotex's product line includes more than 180 pharmaceutical products that are used to fill in excess of 28.6 million prescriptions worldwide annually. The current U.S. product line features 109 products available in 23 different therapeutic categories in all major dosage forms.