Ranbaxy gets US FDA nod for Diovan generic

Ranbaxy Laboratories' New Jersey based wholly owned subsidiary Ohm Laboratories Inc has received a go ahead from the US drug regulator to launch generic version of Novartis' Diovan (valsartan), a blockbuster medicine used in treatment of high blood-pressure.

The company has also secured exclusive marketing rights of the generic drug for 180 days, Ohm Labs said in a statement.

"Ohm is pleased to announce this first-to-file FDA approval for valsartan tablets, which will be introduced to all classes of trade, with 180-days marketing exclusivity, as soon as sufficient supplies are manufactured to meet the needs of the market. Valsartan will be manufactured at the Ohm facilities located in New Brunswick, New Jersey," Bill Winter, Vice President, Sales and Distribution, North America said in the statement.

The approval is for valsartan or generic version of Diovan tablets in the strengths of 40 mg, 80 mg, 160 mg, and 320 mg, it added.

The development is significant for Ranbaxy as it has been facing troubles in the American market for past many years with several of its manufacturing facilities in India being barred from supplying products to the US market following deviations from manufacturing standards. Many of Ranbaxy's key product applications including potential first-to-files seeking approvals are also stuck with the US Food and Drug Administration (US FDA).

The launch of the Diovan generic was also pending since September 2012, when Novartis lost patent protection for the original product.

The launch of Diovan generic in the US market with exclusive marketing rights is now expected to boost Ranbaxy's revenue, which were under pressure for a long time.

Shares of Ranbaxy Laboratories rose more than 5.38% on Friday to close at Rs 497.15 on the Bombay Stock Exchange. It touched a high of Rs 510.45 during the day.

Total annual sales for Diovan were pegged at $2.19 billion. Market analysts say Ranbaxy is likely to clock about $200 million during the six-month exclusivity period, even if it launches the drug at a discount of 40-50%.

Ranbaxy was recently acquired by Sun Pharma from Japan's Daiichi Sankyo in a $4-billion transaction.