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New Delhi, Sept. 18: Ranbaxy Laboratories Ltd (RLL) has got the approval from the US regulatory authorities to manufacture the generic version of the broad spectrum antibiotic Augmentin.
Industry sources however say Ranbaxys plans to launch the drug in the US market may be delayed due to the legal suits filed by Glaxo, the original innovator of the drug, which owns the Augmentin brand name. The name of the combination drug is Amoxyycillin Clavulanda Potassium tablets (called Amoxyclav, in short).
Speaking to The Telegraph, a Ranbaxy spokesperson said, We have got the nod from the USFDA to launch the generic version of Augmentin. Ranbaxy declined to say when it planned to launch the drug in the US market and whether the legal suits would delay the move. The US market for Augmentin is estimated at about $ 1.5 billion whereas the global market is pegged at about $ 2 billion.
The Indian company, along with Novartis Geneva unit and Israels Teva Pharmaceuticals, have been fighting GSKs exclusivity on the antibiotic drug.
Last month, GSK initiated separate legal action against the
three generic drug makers, claiming they were using stolen bacteria for making copies of the antibiotic. At that time Ranbaxy had come out with a statement that it had not resorted to any unethical means. The case is now before a US court.
Glaxos drug is already facing competition from one generic drug maker the Geneva unit of Novartis, which already has launched the generic version. The approval and subsequent launch of the generic version by Ranbaxy is sure to eat into its revenue pie.
According to the USFDA website, Ranbaxy has received approvals for the 875 milligram and 125 milligram tablets of amoxycillin and clavulanate potassium, the generic form of the drug.
The point to be considered by Ranbaxy is whether to launch its product immediately and risk facing damages if GSK wins its patent case at appeal, or wait until the appeal decision, which industry experts expect around the middle of next year.
Earlier, Ranbaxy chief D. S. Brar had said the company was focussing on the US market for achieving the sales target of $ 1 billion.
We are looking at a major production facility in the United States of America for the simple reason that the US accounts for nearly 50 per cent of the global pharmaceutical market.
Keeping this in mind, the company has strategically shifted its geographical business mix. In 2001, 19 per cent of business came from the US market while in the first half of 2002, Ranbaxy has got 35 per cent of its $ 355 million business from the US.