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.
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.
