Pfizer is looking to introduce an over-the-counter (OTC) version of its blockbuster cholesterol pill Lipitor (atorvastatin) that could be purchased without a doctor’s prescription, according to a report released today by the Wall Street Journal. The move could help the company retain revenues for the drug, after Lipitor’s patent is set to expire this November. Last year, the blockbuster's sales soared to $11 billion.
Previously, the FDA has scrapped the idea of allowing over-the-counter versions of cholesterol drugs in the same drug class as Lipitor, such as Merk’s lovastatin (Mevacor), due to concerns that patients would not be able to make informed decisions about take the drug properly. The proposal was rejected by the FDA’s Nonprescription Drugs Advisory Committee and its Endocrinology and Metabolic Drugs Advisory Committee and its Endocrinology and Metabolic Drugs Advisory Committee.
Pfizer, however, is hopeful that the FDA may consider the idea as the healthcare agencies look for ways to curb the rising healthcare costs, according to the WSJ. Selling a low-cost version of the drug could be the answer. According to the WSJ, Lipitor currently sells for about $4 to $5 per pill; however, an OTC version of the pill would sell for less.
Similarly, a nonprescription version of simvastatin (Zocor, Merck Pharmaceuticals) is currently being sold behind the counter at U.K. pharmacies.
However, even if the FDA approves an over-the-counter version of Lipitor, the drug will not be available in November when the patent is set to expire, according to the WSJ. Most likely, Pfizer will need to conduct additional research to convince the FDA that consumers will be able to make informed decisions about taking the drug and follow the drug label for taking an OTC version of Lipitor.
In response for a comment, MacKay Jimeson, representative from Pfizer confirmed that "we have strategic plans in place for Lipitor’s loss of exclusivity and will comment no further at this time."