A big slice of the U.S. prescription-drug market will change Wednesday, when Lipitor, the world's best-selling drug, gets generic competition.
Black Friday-like rushes on pharmacies are not expected, but the change, at least in theory, will lower prices for patients trying to lower their cholesterol.
The drug still requires a doctor's prescription. Ian Read, chief executive of Lipitor's maker, Pfizer Inc., said recently that the company hoped to create a nonprescription version. But that is at least several years away and would need approval from the Food and Drug Administration.
Lipitor, on the market since 1997, is among drugs called statins, which are meant to lower cholesterol and reduce the chance of heart attack or stroke. Lipitor's chemical name is atorvastatin calcium, and those words will appear on all generic pill labels.
Generic drugs must be approved by the FDA before they can be legally sold in the United States, but the process is shorter and cheaper than with original brand-name drugs. With patent protections in effect, brand-name manufacturers generally charge enough for the drug to recoup costs and make as much profit as possible. Once a patent expires, the generic manufacturer is essentially copying the formula, although shape, color, and inactive ingredients of the generic pills will differ from the branded version.
Pfizer, based in Manhattan, but with operations in Collegeville, had about $10.7 billion in global Lipitor sales in 2010 to about three million patients.
Several top-selling drugs will reach patent expiration in the coming months, but patents expire at different times in different countries. For example, Teva Pharmaceuticals, based in Israel, but with its Americas headquarters in North Wales, began selling generic Lipitor in Canada in 2010, as did Watson Pharmaceuticals.
Watson, based in Parsippany, N.J., has a deal with Pfizer to sell a Pfizer-manufactured generic Lipitor for the next 180 days, after which there might be five or six manufacturers. For now, the only independent generic seller, pending FDA approval, in the United States will be Ranbaxy Pharmaceuticals Ltd., an India-based company with U.S. headquarters in Princeton.
For patients wanting the brand-name product, regardless of cost, the best way is to have a doctor write the prescription specifically for Lipitor. Pennsylvania and New Jersey laws require that pharmacies use a lower-cost generic version, unless the prescription specifically says that the brand name is to be used.
Those laws assume the generic is lower-priced, but for the next six months, that might not be true.
Pfizer is offering a $4 coupon good for a 30-day supply, but it helps only those patients who don't have drug payments reimbursed by Medicare, Medicaid, other federal health-care programs, and many private insurance plans. Pfizer also contracted with Diplomat Specialty Pharmacy of Flint, Mich., to set up a mail-order business, which would ship pills to patients and then bill insurers.
Neither of those moves is especially good for retail pharmacists, especially independents, who make more money on generic sales. One pharmacists' group also objected to Pfizer's better-than-usual deals with some pharmacy benefit managers (PBMs) so that the brand-name drug would be dispensed. Even if patients get the drug for the same lower price, Dave Marley, a founding member of Pharmacists United for Truth and Transparency, said that, unless employers get some of that Pfizer money passed back to them through the PBM, the employers might be inclined to reduce benefits to patients in the future.
CVS/Caremark is both a pharmacy and a PBM. Either way, stores are getting ready for Wednesday, according to the chain's public-relations director, Mike DeAngelis.
"We plan to have a generic alternative available in our pharmacies as soon as possible after that date," DeAngelis said in an e-mail. "We intend to help our patients with Lipitor prescriptions take advantage of the savings that the introduction of generic atorvastatin will provide."