Pfizer (PFE) May Get Several More Months of Lipitor Exclusivity
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Generic drugs - unbranded copies of originals - are big business, amounting to 80 percent of the $307.4 billion spent in the U.S. alone for 2010. Making a generic product takes time, resources, and lots of money.
Oh, and a compliant manufacturing environment.
According to reports Friday, Pfizer (NYSE: PFE) executives may have the most-stressed executives in the world right now. The company's Lipitor cholesterol drug, which brings $11 billion in revenue annually, is under fire from a potential generic. However, India-based Ranbaxy, the company aiming to create "Gener-itor," may not get approval from the U.S. Food and Drug Administration due to regulatory breaches tied to one if it's manufacturing plants.
Ranbaxy has had since 2009 to fix the violations in order to gain approval from the FDA. One analyst said he doesn't remember the last time the first generic on a big drug was dependent on cleaning up a mess in the manufacturing situation, according to Bloomberg.
Pending approval, Ranbaxy will have a 180-day exclusivity to market the generic drug on the U.S. Following that, offerings from several other companies like Dr. Reddy's Labs (NYSE: RDY), Teva Pharmaceuticals (Nasdaq: TEVA), and Mylan (NYSE: MYL) will be able to enter the market.
Lipitor is the best selling drug in the U.S., with annual revs of $7 billion and about 3.5 million Americans prescribed. The delay to generic Lipitor will also cost patients; generic drugs generally sell for about half of what branded counterparts get.
It wasn't made clear how long the delay will be for, but Ranbaxy has said it plans to sell generic Lipitor in the U.S. starting in November - pending FDA approval.
Oh, and a compliant manufacturing environment.
According to reports Friday, Pfizer (NYSE: PFE) executives may have the most-stressed executives in the world right now. The company's Lipitor cholesterol drug, which brings $11 billion in revenue annually, is under fire from a potential generic. However, India-based Ranbaxy, the company aiming to create "Gener-itor," may not get approval from the U.S. Food and Drug Administration due to regulatory breaches tied to one if it's manufacturing plants.
Ranbaxy has had since 2009 to fix the violations in order to gain approval from the FDA. One analyst said he doesn't remember the last time the first generic on a big drug was dependent on cleaning up a mess in the manufacturing situation, according to Bloomberg.
Pending approval, Ranbaxy will have a 180-day exclusivity to market the generic drug on the U.S. Following that, offerings from several other companies like Dr. Reddy's Labs (NYSE: RDY), Teva Pharmaceuticals (Nasdaq: TEVA), and Mylan (NYSE: MYL) will be able to enter the market.
Lipitor is the best selling drug in the U.S., with annual revs of $7 billion and about 3.5 million Americans prescribed. The delay to generic Lipitor will also cost patients; generic drugs generally sell for about half of what branded counterparts get.
It wasn't made clear how long the delay will be for, but Ranbaxy has said it plans to sell generic Lipitor in the U.S. starting in November - pending FDA approval.
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