Ranbaxy Pharmaceuticals received FDA approval for a generic version of Pfizer’s Lipitor and has launched the product, Atorvastatin, in the U.S. Cholesterol-reducing medication Lipitor, the top-selling drug in the world, made $7.89 billion in global sales through the first nine months of 2011.
Being the first to file a marketing application with the FDA, Ranbaxy will have a 180-day period of exclusivity. Pursuant to an agreement with Teva Pharmaceuticals USA, Ranbaxy will pay a portion of the profits from sales of Atorvastatin during this time.
Ranbaxy’s approval covers 10 mg, 20 mg, 40 mg, and 80 mg strengths. The drug will be manufactured by Ohm Laboratories. By next summer, Ranbaxy’s Lipitor copy will be joined by an authorized generic to be sold by Watson Pharmaceuticals. Watson has an exclusive supply agreement with Pfizer, which has agreed to manufacture and sell generic tablets to Watson for five years.
Pfizer maintains rights to Lipitor’s crystalline and amorphous patents, which expire respectively in 2016 and 2017. Pfizer had worked to extend basic patent rights for Lipitor by getting extensions on its patent protection. It also took rivals to court. Most recently, in August, Pfizer filed suit against Merck & Co. to stop it from marketing a pill combining a generic version of Lipitor with Zetia.
Merck’s Zetia blocks absorption of cholesterol within the digestive tract, as opposed to statins like Lipitor that work within the liver. The Merck drug cannot be approved by FDA for about 30 months. Pfizer previously settled a lawsuit with Ranbaxy, following which it also resolved lawsuits with several other generic drug companies like Mylan, Teva, and Dr. Reddy’s Laboratories. Under its agreement with Teva, the companies agreed that Teva would keep generic Lipitor off the U.K. market until Pfizer’s patent in that country expires in May 2012.
Lipitor saw sales peak in 2006 when it brought in $12.9 billion. In 2009, sales were down to $11.4 billion. Last year it made $10.7 billion in worldwide sales with about half coming from the U.S.
In guidance for 2012, Pfizer has warned investors to expect a revenue range of between $62.2 billion and $64.7 billion, down nearly 5% year-over-year at the low end of the range and 3% less at the high end. R&D would fall to between $6.5 and $7 billion, down around 20% at each end of the guidance. Pfizer expects its EPS, however, to bounce back to between $2.25 and $2.35, up 4% at both ends of the guidance.