Pfizer mulls possible OTC Lipitor switch

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Pfizer is reportedly weighing an attempt at an over-the-counter switch for Lipitor — a move that could help the company recoup some of its losses when the $11 billion drug loses nationwide exclusivity in November. But the reception from analysts has been muted so far.

The New York Times reported that Pfizer is exploring the possibility of a branded generic, as well as an OTC switch.

Both options would put the company's marketing prowess to use, but to win FDA approval for an OTC version, Pfizer would have to succeed where Merck and Bristol-Myers Squibb have failed.

Deutsche Bank analyst Barbara Ryan splashed cold water on Pfizer's prospects.

“I do not think that an OTC Lipitor is likely over the next few years,” Ryan said. “Merck tried with Mevacor for better than five years, and finally gave up. The issue is the asymptomatic nature of the disease. That has not changed.”
Mary Tinetti, M.D., chair of the FDA's non-prescription drugs advisory committee, wrote in a 2008 journal article that the reasons advisory committees rejected a Mevacor OTC switch for a third time in 2007 included “insufficient data on benefits and risks in the target population.”