Lipitor won't be sold over-the-counter, but Pfizer keeping OTC business

NEW YORK - Statins will remain in prescription-only status following Pfizer's announcement Tuesday that the company is pulling the plug on its Rx-to-OTC switch application for Lipitor. 

 

Since losing patent protection in 2011, Lipitor’s sales have fallen from more than $10 billion a year to $2.06 billion last year.

 

It has been actual use studies that have historically scuttled switch applications for OTC lipid-lowering medicines in the past, and such is the case here. According to a Bloomberg report, a trial of 1,300 patients failed to check their cholesterol levels and seek follow-up doctor care when appropriate. 

 

Pfizer had completed its actual use trial for Lipitor (atorvastatin calcium) 10 mg in December 2014. However, "the study did not meet its primary objectives of demonstrating patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, take appropriate action based on their test results," Pfizer stated. "Based on dialogue with the FDA about the program and analysis of this data, the program was terminated."

 

"That said, we continue to evaluate other products for potential Rx-to-OTC switches," commented Ian Read, chairman and CEO Pfizer, before analysts during the company's quarterly conference call Tuesday. And the overall OTC book of business is still valuable to Pfizer, he added, deflecting speculation that without a Lipitor switch, Pfizer may look to divest its non-prescription business. 

 

"Look, the consumer business is a tremendous business, a tremendous store of value," he said, pointing to the recent success of the Nexium 24HR switch. "At this moment, I think the consumer business is a very valuable and growing asset for Pfizer."