Drugmaker Pfizer Inc. intends to develop an over-the-counter version of its blockbuster cholesterol drug Lipitor. The drug, which generates more than $10 billion in annual sales, loses its patent protection at the end of the month and revenues are expected to drop by half next year when cheaper generics become available.
Moving the statin over-the-counter is meant to broaden the market for the drug and squeeze out profits at the end of a drug’s patent life-cycle.
In addition to Lipitor, dozens of popular brand-name drugs are set to fall off the patent cliff in the next few years, costing Big Pharma billions in revenues. Industry analyst Ryan McGuire, with Cutting Edge Information, said that does not mean a slew of new drugs will be available without a prescription.
“The OTC strategy is one of the rarer ones used to help preserve brand revenues,” McGuire said. “Just because not every brand can be brought over the counter.”
Some of the big sellers set to go off-patent soon are antibiotics and anti-psychotics, drugs not likely to win approval for patients to administer themselves. McGuire said the plan is the latest step Pfizer has taken to protect revenue from its biggest seller, but it would not be a slam-dunk for the company.
“It’s not going to fully stop the bleeding, but it could keep Pfizer’s brand on the shelves in a place where consumers have never seen it before, so there could be other commercial benefits like that,” McGuire said.
Pfizer’s CEO said the company does not know yet if it can prove to the FDA that the drug is safe without a prescription. Temple University pharmacy professor Albert Wertheimer said he is against the idea of an over-the-counter statin.
“The patient has no idea if they’re taking too much unless they do their own liver enzymes or muscle tests. They won’t know if it’s effective, if it’s too much, too little, or if it’s making any progress,” Wertheimer said. “It’s not a good idea.”
The FDA has rejected bids by Merck & Co. to develop an over-the-counter anti-cholesterol drug.
If Pfizer’s plan is approved, it would be at least two years before over-the-counter Lipitor hits the shelves.