Where is Ranbaxy's copycat version of Diovan?

It looks as if Novartis ($NVS) has a temporary and partial reprieve from Diovan competition in the U.S. The Swiss drugmaker's top-selling hypertension remedy went off patent on Friday, but a generic version hasn't hit the market. Ranbaxy Laboratories, which owns exclusive rights to generic Diovan for its first 180 days of marketing, hasn't won FDA approval for its copy.

Copycat versions of Diovan HCT--a combo pill that comprises Diovan's active ingredient, valsartan, along with hydrochlorothiazide--have already shipped, however. Novartis' generic unit Sandoz launched its version of Diovan HCT, as has Mylan.

The Diovan franchise has been Novartis' biggest seller in recent years. Diovan and Diovan HCT together brought in $5.67 billion last year. On its own, Diovan HCT brought in about $1.6 billion for the 12 months ending June 30, Zacks Investment Research points out. Looking just at U.S. sales, the two products accounted for $2.3 billion in sales last year.

So, until Ranbaxy wins FDA's approval--or releases a generic version in partnership with another company--the larger share of the Diovan franchise apparently won't face generic competition in the U.S. Novartis is planning to sell an authorized generic through Sandoz, but the company wouldn't talk about those plans, the India Times reports. And why would it launch its own copy until it needed to answer a third-party challenge?

One big question is whether Ranbaxy's ongoing consent decree with the FDA has interfered with its version of Diovan. The company has said the Diovan generic isn't one of the drugs it had to withdraw from FDA consideration as part of that deal, however. And Ranbaxy CEO Arun Sawhney said early last month that he expected to make the launch. "We remain confident we will be holding the exclusivity ourselves," Sawhney told analysts (as quoted by the India Times).

- read the Times article
- see the report from Zacks
- read the Drug Store News piece