Huge fight expected when statin patents expire

As the countdown on different statin drugs' licenses continues, so do the plans for generic formulations. A generic formulation for simvastatin (Zocor) has received tentative approval, and others are expected to follow.

However, pharmacists should expect that the major drug companies that manufacture statins-such as Pfizer and Merck-will not "go gentle into that good night" of lost profits. These are the strategies that pharmacists can expect to see: combinations that target more than one aspect of lipid dysregulation and efforts to maintain branding so that patients are reluctant to use generics. However, an effort to get the Food & Drug Administration to approve drugs in the statin class for over-the-counter (OTC) dispensing is unlikely to be met with success, according to several sources.

In separate telephone interviews with Drug Topics, several experts discussed their views on what manufacturers' next steps might be. "Although several generic formulations will become available, companies that manufacture statins will take several innovative steps with their drugs." So said Elio Evangelista, a senior research analyst at Durham, N.C.-based Cutting Edge Information, which has been tracking the statin market for some time. Last year, Drug Topics highlighted Cutting Edge Information's report, "Combating Statins: Pharmaceutical Brand Defense." The report anticipated that the FDA would not look favorably on OTC applications for statins until "the industry can prove that the public can safely self-medicate with statins," but that "with many blockbuster statin products approaching patent expiration ... the industry will have to act fast."

Some protective actions may consist of combination drugs that combine the statin with a lipid-lowering agent that works by another mechanism, with Pfizer highlighting the Lipitor component. One possibility would be a combination of Lipitor with Pfizer's torcetrapid-an agent that raises high-density lipoprotein (HDL) cholesterol and lowers low-density lipoprotein (LDL) cholesterol-so that the two drugs would favorably influence the total cholesterol-HDL ratio.

"When patients take a drug that works for a long time, they're reluctant to switch," Evangelista commented. "Pfizer's banking on patients preferring a Lipitor add-on to a switch. Other drug companies are taking that action as well."

An example would be Vytorin, which combines Merck's statin simvastatin (Zocor) with ezetimibe (Zetia), which is produced by Schering-Plough and inhibits absorption of cholesterol into the liver and intestines. Merck is hoping that Vytorin can fend off the encroachments of generic simvastatin, which is already commercially available.

The availability of generic simvastatin will affect the pricing of the statin class overall, Evangelista said. He noted that Zocor was the second-highest selling drug in 2004, with worldwide sales of $5.2 billion. Therefore, Merck will be affected first and others subsequently as they are forced to lower prices to compete with generic simvastatin.

OTC statins: Not for now The prospect of statins going OTC is not on the near horizon and may not be on the distant one either, according to Evangelista. "The FDA doesn't look too enthusiastically at this strategy," he said. "It still wants to see if it is safe for statins to go OTC. The chief concern is that patients may overuse a statin drug.

"An additional concern centers around drug-drug interaction, including the prospect that some patients would combine an OTC statin with a prescription formulation." For now, pharmacists can expect statins to continue to be available only by prescription in the United States, he said.