March 8, 2021

Pfizer Is Said to Pursue Nonprescription Lipitor

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.

The person close to the situation, who would speak only anonymously because the discussions were private, said a nonprescription version of the drug was not the only option pursued by Pfizer. Another would be a so-called branded generic version. The company might pursue both options.

Pfizer announced last month that it was looking to sell or spin off animal health and baby formula businesses to streamline the company and help prepare for the loss of Lipitor sales to generic competitors.

But the company decided to keep two businesses that Wall Street had speculated might be sold: the generic drug business and the consumer business, which now sells products like Advil and Robitussin. That has led to speculation that the company was planning to sell generic and over-the-counter versions of Lipitor and other drugs that face a loss of patent protection.

Pfizer’s plans for the nonprescription Lipitor were first reported by The Wall Street Journal.

An over-the-counter version of Lipitor would no doubt be welcomed by insurers because it would cost less.

In the past, the F.D.A. advisers have been concerned that over-the counter versions of statins could not be used safely, that some patients who did not need the drugs would take them.

Others at significant risk of cardiovascular problems might take the over-the-counter drug and forgo seeing a doctor or getting other necessary care.

Since high cholesterol is a symptomless condition, consumers would not know whether the drug was working without having their cholesterol checked periodically.

But Steven Francesco of Francesco International, a consulting firm that specializes in converting brand name drugs to over-the-counter products, said technology such as prescription cards used at the drug store would better allow patients to be monitored without physician supervision.

“There’s any number of ways to insure that the consumer can use the drug,” said Mr. Francesco. “Lipitor will be one of the first of many drugs that will attempt to switch between now and 2016.”

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