Selling a version of the drug to consumers without a prescription would allow Pfizer to retain some of the $11 billion in annual revenue that Lipitor has been generating.
However, a nonprescription version would not be available immediately after the patent on Lipitor expires because Pfizer would first have to convince the Food and Drug Administration that consumers could take the drug without a doctor’s supervision.
That will probably be difficult. Merck failed three times to win the agency’s approval for over-the-counter versions of Mevacor, which, like Lipitor, is a statin. Bristol-Myers Squibb also failed to obtain approval for an over-the-counter version of Pravachol, another statin.
Pfizer declined to either confirm or deny its intention. “We can confirm that we have strategic plans in place for Lipitor’s loss of exclusivity and will comment no further at this time,” Raymond F. Kerins Jr., a spokesman for the company, said.
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