Novartis may finally face generic competition for Diovan Sources say Ranbaxy has plan to make copy in U.S. January 16, 2014 | By Eric Palmer 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.
Wouldn't the active ingredient supplier be Teva, who already supplies generic valsartan to much of the rest of the world?
Nor hiding that fact that the company relies on overpaid reps to flog over priced branded drugs to the US Health Care market where is costs twice as much to produce the same or lesser healthcare outcomes. This is but one of a future set of nails in the coffin of the screw-job of Pharma as we now know it in the US.
lets wait and see what happens with the diclofenac market. perhaps just a test for more to come.. my guess is that suffern will be culled just for political reasons
Ranbury in India has had its plants closed to the U.S. marketplace last week because of quality control issues. None of its products can be imported until it receives approval from the FDA presumably after another inspection.
I had to change from Diovan from Novartis to Valsartan from OHM two months ago due to insurance requirements and my blood pressure was all over the place. Up and down for no reason. My doctor wanted me to take an additional BP med in the morning and the Valsartan at night even when I explained that I firmly believed the generic med was the problem. I tried her plan and all I had was high BP and and continuous headache. I insisted on going back to the brand Diovan and my BP is now back to normal. Different is not always better. Perhaps the generic Valsartan needs a closer look.