Healthcare Tips

Pfizer Seeks To Develop OTC Lipitor Product As Patent Runs Out

June 28, 2017

As pharmaceutical giants begin to lose patients on their blockbuster money making drugs that have funded their empire for years, these manufacturers are now turning to ways to continue the profit streams by developing over the counter (OTC) versions of their products. Pfizer is no different as it hopes to introduce an OTC version of Lipitor, the world's best-selling drug, after it loses patent protection in November. The Wall Street Journal first caught wind of this days ago. (see link to full article below)

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.

The FDA stands guard however, and 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.

Prescription-to-OTC switches have been rare in recent years, but some have been commercially successful, including Johnson & Johnson's (JNJ) launch of an over-the-counter version of allergy drug Zyrtec after Pfizer's prescription version lost patent protection, as well as Merck's allergy pill Claritin, which it inherited through its acquisition of Schering-Plough.

Merck's Claritin OTC generated $401 million in sales for 2010. In comparison, annual sales of the prescription version of Claritin once exceeded $3 billion before the drug lost U.S. patent protection nearly a decade ago.

Pfizer spokesperson Raymond F. Kerins Jr. stated:

"We can confirm that we have strategic plans in place for Lipitor's loss of exclusivity and will comment no further at this time."

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.

By the end of next year, 7 of the 20 top selling medications will lose their patent protection, making way for much cheaper generic or OTC versions. This is a godsend for patients, and a serious concern for the pharmaceutical industry which depends so much on high incomes for research and development.

Health experts in the United States say that a significant number of people who cannot currently afford to pay for their medications, will soon be able to do so. The USA is one of the most expensive countries in the world for prescription medications.

In America today, many people even with private health insurance or Medicare cover are not getting their prescriptions because they simply do not have the money.

Studies have shown that generic drugs are just as good as the brand name ones, says the FDA. As long as the active ingredient is the same, the medication is just as effective. Some argue that generic versions have uneven safety records. However, studies have shown that brand named drugs have the same risk of contamination due to some bad manufacturing practice, or another reason.

Steven Francesco of Francesco International, a consulting firm that specializes in converting brand name drugs to over-the-counter products adds:

"There's any number of ways to insure that the consumer can use the drug. Lipitor will be one of the first of many drugs that will attempt to switch between now and 2016."

Sy Kraft

View drug information on Claritin RediTabs; Mevacor; Pravachol.