Mumbai, June 27: Ranbaxy Laboratories, which has been facing regulatory hurdles in the US, has been allowed to sell Valsartan tablets in the American market.
Valsartan is the generic version of Novartis’s Diovan, a highly successful drug with global sales of over $3 billion, and is used for treating high blood pressure and heart failure.
Ohm Laboratories Inc, a wholly owned subsidiary of Ranbaxy, has received approval from the US Food and Drug Administration to manufacture the drug with 180 days of marketing exclusivity, Ranbaxy Laboratories said in a statement.
The exclusivity period is expected to have a positive impact on Ranbaxy’s balance sheet as analysts expect it to yield $200 million for Ranbaxy in sales.
The patent for Diovan had expired in 2012 and the launch of the generic version has been pending since.
The Gurgaon-based company, which is set to be acquired by Sun Pharmaceutical, could not manufacture the drug because of problems at its plants.
Under the FDA norms, the first applicant for a generic drug that submits a paragraph IV application and successfully defends a patent infringement suit is entitled to a 180-day exclusivity.
A Para IV filing is made when the applicant of the generic drug feels that the product does not infringe on the innovator’s patents.
“Ohm is pleased to announce this first-to-file FDA approval for Valsartan tablets, which will be introduced to all classes of trade as soon as sufficient supplies are manufactured to meet the needs of the market. Valsartan will be manufactured at Ohm’s facilities in New Brunswick, New Jersey,” Bill Winter, vice-president, sales and distribution, North America, said.
“For the US healthcare system, Valsartan adds to the growing portfolio of generic medications, which have played such an integral role in helping to alleviate the burdens of rising costs of treatment,” Winter said.
However, a few experts feel that Ranbaxy will not be able to reap the full benefits of the drug since it will have to source active pharmaceutical ingredients (APIs) from another source. Ranbaxy’s API unit in Toansa, Punjab, has been barred by the FDA from exporting to the US.
According to Sarabjit Kour Nangra (VP, research-pharma, Angel Broking), Ranbaxy may clock close to $200 million during its six-month exclusivity period if it launches the drug at a 40-50 per cent discount to the innovator’s branded version and manages to corner half of the market share in the US.
She said Ranbaxy may garner around $30 million in profits during the period.
The stock markets gave a thumbs-up to the development. On the BSE, the Ranbaxy scrip gained 5.38 per cent, or Rs 25.40, to end at Rs 497.15, while Sun Pharma rose 4 per cent to Rs 660.65.
Market circles feel that with Ranbaxy securing the approval for Valsartan, doors may open for a couple of other generic drugs that have good sales potential.