Novartis' ($NVS) blockbuster Diovan has enjoyed nearly 18 months of sales unscathed by generics since its patent expired in September 2012, but the after-party may be about to end. Regulatory entanglements have kept Ranbaxy Laboratories from producing its copycat version, but the Indian drugmaker has a plan to finally get it to market and claim its 6 months of exclusivity.
Citing unnamed sources, India's Business Standard reported that Ranbaxy has applied to the FDA to make the drug at its Ohm Laboratories plant in New Jersey, using an active pharmaceutical ingredient produced by another company. Ohm is the only Ranbaxy FDA-approved plant that the agency has not banned from selling in the U.S. Its plant in Mohali, India, where it was expected to produce its version of Diovan, as well as two other Indian facilities, have been cut off over poor manufacturing practices. Ranbaxy did not comment on the report.
It is unfortunate news for Novartis. Diovan has provided the proverbial icing on the cake for its financial reports in the 5 quarters since its patent lapsed in the U.S. Sprinkled throughout those reports are references to the fact that its sales have benefited from "delayed entry of generic competition for Diovan monotherapy in the U.S." Revenues from Diovan were down 22% in the first three quarters of 2013 but still reached $2.68 billion for 9 months, an amount that is far healthier than if generics were eating away at them. After its second-quarter report, the Swiss drugmaker raised its guidance for the year because of the missing competitor.
Ranbaxy was initially forecast to generate $187 million during its 6-month exclusivity with Diovan, but the delay may affect that. Mylan ($MYL) tried a couple 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. Other generics won't come to the market until after Ranbaxy exercises its exclusivity.
- here's the Business Standard story
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