Lupin Ltd has managed to wrest some control over Lipitor, the world’s biggest-selling medicine, from its manufacturer Pfizer.
The FDA (Food and Drug Administration) has granted the Mumbai-based company permission to seek approval for a copy of the cholesterol drug. But unlike Pfizer’s Lipitor, which is in tablet form, Lupin’s would be a capsule.
The FDA nod follows a petition filed by Lupin in 2008, seeking permission to file for a capsule form of Lipitor so that the drug could be available to people having difficulty swallowing a tablet form.
The FDA said Lupin’s version wouldn’t pose safety or efficacy problems since its uses and the oral route of administration are similar to Lipitor’s.
A Lupin spokesperson decline to comment.
However, it would still be some time before Lupin’s version is launched in the US as it would have to go through the generic drug approval process.
Experts said Lupin would take two years to hit the market. By then, some patents on Lipitor would expire. Experts said if Lupin captures even 10% of the Lipitor pie, it would boost its ales significantly. The company posted sales of Rs4,741 crore in 2009-10.
Pfizer’s US patents for Lipitor expire this year and in 2011, 2016 and 2017. The drug had sales of $11.4 billion last year.
Ranbaxy, which had settled its patent litigation with Pfizer over Lipitor, is allowed to start selling its version of the drug from November 30, 2011.
Pfizer has also granted US-based Watson Pharma rights to sell an authorised generic of Lipitor in the US for five years, beginning November 2011.
“So, by the time Lupin’s version comes out, there would already be versions by Ranbaxy and Watson, apart from Pfizer. Nevertheless, Lupin will have the first mover advantage in the capsule form of Lipitor as the others will all have tablet versions,” said Ranjit Kapadia, vice-president, institutional research, HDFC Securities.
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