Pfizer is interested in selling a non-prescription version of its Lipitor cholesterol drug but would likely face a battle with regulators because of safety concerns, the Wall Street Journal reported Wednesday.
The pharmaceutical giant is seeking options to extend the life of the blockbuster drug, which bringsin $11 billion in sales but will lose its patent protection in November, opening the door to cheaper generic versions.
One option would be to produce a cheaper, non-prescription version of the drug, although an FDA spokeswoman told the newspaper that previous research has shown that consumers are unlikely to make correct decisions about using anti-cholesterol drugs like Lipitor, known as statins.
Even if the move were approved it would be unlikely to happen in time for the November expiration of patent protection, according to the Journal, which cited "people familiar with the matter."
The FDA has rejected previous efforts by Merck to sell a nonprescription version of the statin Mevacor. One reason was studies that showed many people who thought they should be taking the drug were outside the target population, meaning the risks would likely outweigh any benefits, the Journal said.
Pfizer spokesman Ray Kerins declined to comment on the report, telling Reuters only that Pfizer has "strategic plans in place for Lipitor's loss of exclusivity."