Nonprescription Version of Lipitor on the Horizon?

With pharmaceutical Giant Pfizer’s expiring patent for the manufacture of their multi-billion dollar drug Lipitor fast approaching, the company hopes to gain approval from the U.S. Food and Drug Administration (FDA) for the introduction of an over-the-counter version.

Lipitor, the world’s best-selling drug, currently generates $11 billion in annual revenue for Pfizer, but the blockbuster medication is scheduled to go off-patent in November of this year. The cholesterol-lowering statin drug has already lost patent protection for sales in Canada, Spain, Brazil and Mexico.

However, the availability of an over-the-counter version of the drug is by no means a done deal. Pfizer must do much to convince the FDA that consumers could safely take the drug without doctor supervision. This is likely no easy feat as pharmaceutical competitor Merck has failed repeatedly (three times) to gain the federal agency’s approval to manufacture a nonprescription version of the statin marketed under the trade name Mevacor, while Bristol-Myers Squibb was also unable to obtain approval for an over-the-counter version of their statin drug known as Pravachol.

Pfizer declined any confirmation or denial of its intentions, as communicated by company spokesman Raymond F. Kerins Jr. in the statement, “We can confirm that we have strategic plans in place for Lipitor’s loss of exclusivity and will comment no further at this time.” However, an anonymous person who is close to the situation pointed out that this is an option under consideration for the company’s pursuit. But, the unnamed source also acknowledged that seeking a nonprescription version of the drug is not the only action being considered, as Pfizer could also pursue a branded generic version, or even both options.