Fat returns from Lipitor

Lipitor, the blockbuster anti-cholesterol drug from Pfizer, is the world's largest-selling drug in terms of value and it went off patent last Wednesday (November 30, 2011). As is to be expected, the shift raises questions on the implications for the global pharma major Pfizer, generic pharma companies globally and especially companies based in India, who could now launch copied versions of the drug in the US.
 
In 2010, revenues from Lipitor were approximately $10.7 billion, a pot that generics companies might now be able to share.
 
Among Indian companies, Ranbaxy Laboratories, (part of Japanese pharma major Daiichi Sankyo) will be a major beneficiary as it was the first to file with the U.S. Food and Drug Administration for the launch of a generic version. Because of this move, Ranbaxy will get a 180-day market exclusivity period in the US.  Other companies can launch their generics only after the market exclusivity period for Ranbaxy ends, except of course Watson Pharmaceuticals, which has a partnership with Pfizer to sell the authorised generic of Lipitor.
 
A day after the patent expired for Lipitor, Ranbaxy announced that its wholly-owned subsidiary, Ranbaxy Pharmaceuticals Inc, had received final approval from the FDA to manufacture and market a generic version of Lipitor known as Atorvastatin and has launched the product in the US market.  Atorvastatin generated total annual sales of $7.89 billion in the United States through September 2011, according to the company.
 
The company's official release also suggests what seems to be a profit sharing agreement with Teva Pharmaceuticals, USA, for the 180-day market exclusivity period, although the company refused to disclose the terms of the agreement.
 
Ranbaxy has not commented on expectations from the exclusivity period, but analysts have said that it could see an addition of anything between $100 million and $600 million to the company's topline during the period.
 
Pfizer ready with plans
 
But then, it may not be easy for Ranbaxy and other players, because Pfizer also has a strategy ready for after the patent expiry. A Pfizer spokesperson told BT:  "To create the most options for patients and lower costs during the 180-day exclusivity period, we are offering Lipitor at or below the cost of a generic. This ensures access to this medication in a time of rapid change in an unpredictable marketplace."

"Our strategy during the 180-day period is to help patients who want to stay on Lipitor have access to the brand after loss of exclusivity on November 30. Our programs, which are designed to offer Lipitor at or below generic cost during the 180-day period, will not increase costs for the significant number of payers participating in our programs,''  the spokesperson added.
 
The spokesman also said that the company had offered contracts that would make Lipitor available at or below generic cost beginning November 30.  Watson also planned to launch its authorised Lipitor generic on the same day.