Ranbaxy faces pitfalls on road to Lipitor copy

Ranbaxy Laboratories may have won a coveted license to market a knockoff version of the megablockbuster cholesterol drug Lipitor. But the Indian generics maker could find that it's tougher to reap the benefits of that license than it had expected.

Ranbaxy has ongoing regulatory problems that could interfere with its generic Lipitor launch. The FDA has yet to approve its generic version of the drug--indeed, the agency has yet to clear dozens of Ranbaxy meds that have been on import alert since 2008. With first-to-file status, Ranbaxy is due 180 days of exclusivity--and if it can't get its act together, that exclusivity will go to waste.

So, Mylan has sued the FDA to block its approval of Ranbaxy's Lipitor copy, maintaining the agency should allow other generics makers to step into the Lipitor market as soon as Pfizer's patent expires. In its suit, Mylan cites Ranbaxy's troubled plant in Paonta Sahib, India, which may be the site of its Lipitor production. FDA typically blocks new drugs from plants that remain under its scrutiny.

But even if Ranbaxy gets to market first and on time, it could run into another snag. In fact, any drugmaker looking to knock off Lipitor faces the same problem--even Watson Laboratories, which is on contract to make an authorized generic. As Bloomberg reports, Pfizer is offering to subsidize co-pays for users of the branded version.

People who pay less than $54 per month in co-pays will be able to get Lipitor for $4. Others will get a $50 discount on costs of up to $150. That would make branded Lipitor competitive with knock-off versions. "As the co-pay on Lipitor would be comparable to that on its generics, the shift to generics may be scuttled," Deustche Bank's Mumbai-based analysts Abhay Shanbhag and Mayank Kankaria said in a report to investors (as quoted by Bloomberg).

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