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FDA Approves Ranbaxy Subsidiary’s Generic Valsartan

Annual brand-name Diovan sales exceed $2 billion for Novartis

A wholly owned subsidiary of Ranbaxy Laboratories Ltd. has received FDA approval to manufacture and market valsartan — the long-delayed generic version of Diovan, which has annual sales of $2.1 billion.

The FDA determined that Ohm Laboratories’ 40-mg, 80-mg, 160-mg, and 320-mg valsartan tablets were equivalent to Novartis’ Diovan, which is indicated for the treatment of high blood pressure and heart failure.

Diovan went off patent in 2012, but Ranbaxy — which had first-to-file marketing exclusivity for generic valsartan — was unable to start selling the drug because of problems with FDA inspectors over quality issues at its plants. Four of Ranbaxy’s five FDA-approved plants are banned from making products for the U.S. market.

Valsartan will be manufactured at an Ohm facility that has escaped the FDA bans in New Brunswick, New Jersey.

Ranbaxy has 180 days of marketing exclusivity for the drug. "We have been anticipating marketing approval of Valsartan for some time, now, and we are very pleased that this has finally come to fruition.” said Bill Winter, Ranbaxy’s Vice President for Sales and Distribution in North America. Ohm will introduce valsartan “as soon as sufficient supplies are manufactured to meet the needs of the market,” he said.

Although other drug manufacturers have challenged Ranbaxy's exclusivity in court, the FDA contended its hands were tied by law and won its case in 2012. Some experts believe the case exposed a flaw in process.

In April, Sun Pharmaceutical announced it had a $3.2 billion stock deal to buy Ranbaxy from Daiichi Sankyo.

Sources: Ohm Laboratories; June 27, 2014; and Fierce Pharma; June 26, 2014.

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