UPDATED: Reported Form 483 may explain Ranbaxy not getting Diovan to market

Ranbaxy Laboratories had the 6-month exclusive right to produce a generic of Novartis' ($NVS) blockbuster hypertension fighter Diovan. But the patent loss came and went months ago, and Ranbaxy's generic remains missing in action. Now reports suggest the launch was delayed because of FDA manufacturing concerns at Ranbaxy's Mohali plant that was to produce it.

India's Business Standard, citing sources, says that Ranbaxy received a Form 483 from the FDA several months ago following an inspection of supplies of valsartan, the generic of Diovan. The patent for Diovan fell off in September, and the publication says the Indian generics maker was forecast to generate $187 million during the 6-month exclusivity. Mylan ($MYL) tried a couple of times to get the FDA to cancel the exclusivity since Ranbaxy's drug had yet to be approved, but it was turned back in those efforts. Ranjit Kapadia, an analyst with Centrum Broking, said it remains unclear when the drug will be launched. Given competition from other drugs, he thinks Ranbaxy's sales of valsartan will be cut in half.

A Ranbaxy spokesman declined to comment to FiercePharma about whether a Form 483 had been issued for the plant but did say in an email, "We continue to make regulatory submissions from Mohali and will commercialize products from Mohali when we get approvals.  As well, and with respect to Valsartan, we continue to work with the FDA to gain approval for this molecule."

While the news undercut Ranbaxy's shares in trading in India, it has worked to the advantage of Novartis, which continues to sell Diovan. Mylan has had a copycat of Diovan HCT--a combo pill that comprises valsartan and hydrochlorothiazide-- on the market for months, as has Novartis' generic unit Sandoz. Last year, the Diovan franchise produced $5.67 billion for the Swiss drugmaker. But Novartis is seeing dropoff even without the Ranbaxy drug showing up. Diovan generated just $918 million last quarter, down from $1.19 billion in the same quarter a year ago. Novartis expects that to change beginning next quarter, however, as Ranbaxy's 6-month exclusivity expires and the generic floodgates open.

- read the Business Standard story

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