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Indian generic makers lead race for Coreg market

Dr Reddy’s, Ranbaxy among 7 Indian cos to get US FDA nod

P.T. Jyothi Datta

Mumbai, Sept. 6 Of 14 drug makers that received regulatory approval on Thursday to sell generic copies of GlaxoSmithKline’s blood-pressure drug Carvedilol in the US, seven are from India.

A day after the patent expired on GSK’s carvedilol, sold under the brandname Coreg – the regulatory US Food and Drug Administration (USFDA) approved the sale of generic copies by 14 companies.

Sun Pharma (through it’s Caraco subsidiary), Aurobindo Pharma, Dr Reddy’s Laboratories, Glenmark Pharmaceuticals, Lupin Ltd, Zydus Pharmaceuticals and Ranbaxy Laboratories Pharmaceuticals are the seven Indian drug companies that will seek to get a slice of the $1.7 billion carvedilol market.

The other seven drug companies also in the fray include Actavis, Apotex, Mylan, Watson, Teva, Taro and Sandoz.

Prices may go down

With several companies offering the generic copy of the medicine, a rapid price erosion of as much as 95 per cent is expected, observed an analyst, citing a trend that is almost always seen when a drug goes off patent.

Companies will be looking to launch their respective versions sooner than later in the US, to garner their share. Ranbaxy, for instance, has indicated that it would launch the drug by the fourth quarter of 2007.

Carvedilol is a beta-blocker indicated in patients with high blood-pressure and heart failures. It acts by reducing the workload on the heart, thus reducing blood pressure, a note from GSK said.

Interestingly, GSK introduced the same drug formally in the Indian market only late last month, being virtually the last entrant to tap this market, an analyst said. But with generic copies already selling in India, GSK may be looking to expand the use of its drug in the BP segment as well, as compared to its earlier use in just heart failure and there lies the opportunity, pointed out a Mumbai-based endocrinologist.

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