Mumbai, March 21: Ranbaxy Laboratories plans to launch the generic version of the worlds largest selling drug — Lipitor — have hit a roadblock.
Mylan Inc has sued the US Food and Drug Administrator in a US court in an effort to stymie the approval process for the grant of a six-month marketing exclusivity to Gurgaon-based Ranbaxy starting this November for a generic version of the cholesterol-lowering drug.
Lipitor is a blockbuster drug owned by Pfizer. Last year, Pfizer racked up $10.7 billion from worldwide sales of Lipitor. In the US alone, it earned $6 billion from the drug.
Ranbaxy had reached an agreement with Pfizer to launch a generic version of Lipitor. It is still waiting for formal approval from the FDA for its generic version.
Mylan Inc, which is also looking to market its version of the drug later, has filed a complaint in a Washington court.
Mylan argued that Ranbaxy was not eligible for marketing exclusivity for the cholesterol-lowering drug as it had buttressed its claim using false and unreliable data from its manufacturing site in Paonta Sahib.
It may be recalled that in 2009, the US drug regulator had halted the review of all pending and new generic drug applications from this facility located in Himachal Pradesh.
The Ranbaxy shares tumbled almost 7 per cent, or Rs 32.60, to Rs 435.95 — an indication of the upside that has built into the stock from anticipated sales from the generic version of Lipitor.
Analysts had estimated atorvastatin — the generic name for Lipitor — to contribute between $500 million and $600 million to Ranbaxys sales and add Rs 26-36 in earnings per share from the US alone.
Pharmaceutical analysts, however, felt that the sharp fall in the scrip was a knee-jerk reaction to the news and it was too early to say whether Ranbaxy would be denied marketing exclusivity.
They acknowledged that it would be a huge negative for the Daiichi Sankyo subsidiary if it failed to win the FDA approval.
Surajit Pal, pharmaceutical analyst at Elara Capital, said that while one could not predict what the courts would decide, the assumption of Mylan that the drug would be produced in Paonta Sahib might not be correct. Pal was optimistic that Ranbaxy would be able to launch the drug as scheduled.
Sushant Dalmia of PINC Research said Ranbaxy was likely to manufacture the drug from some other facility.