DEB GRUVER / McClatchy Newspapers | Posted: Monday, October 23, 2006 7:00 pm
WICHITA, Kan. — Judy Beals doesn’t have to take a lot of medications, but when she does, she tries to get the generic form. She has no qualms about straying from the brand name for one reason:
“I don’t pay nearly as much,” the Wichita resident said.
Consumers such as Beals have more choices than ever when it comes to generics, which are lower-cost versions of brand-name drugs.
So far this year, the U.S. Food and Drug Administration has approved 67 drugs for first-time use in generic form, including Xanax XR for anxiety, Flonase nasal spray for seasonal allergies, Percocet for pain, Lexapro and Zoloft for depression and anxiety, and Zocor for cholesterol. For a full list, go to www.fda.gov/cder/ogd/approvals.
That number compares with 47 new generics for the same period last year and 46 for the same period in 2001.
And more are on the way.
Brand-name drugs for which patents will expire in the next few years include Wellbutrin XL for depression and smoking cessation (this year), Imitrex for migraines (next year), Advair for asthma (2008), Zyrtec and Clarinex for allergies and Valtrex for herpes (2009), according to the Generic Pharmaceutical Association.
Patents protect the company that introduced a drug. Companies that wish to bring a generic to market can wait until the patent expires or, in some cases, challenge the patent.
According to the FDA, 8,730 of 11,487 drugs have generic counterparts.
That means savings for consumers, especially when multiple companies offer a generic form and compete against one another.
In 2004, the average price of a generic prescription drug was $28.71 compared with $94.54 for the average price of a brand-name prescription, according to the National Association of Chain Drug Stores.
Generic drugs represented 66.4 percent of prescription doses sold in 2004, compared with 61 percent in 2001, said Scott Gottlieb, deputy commissioner for medical and scientific affairs for the FDA, in an April speech.
IMS Health, the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries, says brand-name medication with annual sales of about $64 billion will come off patent in the next five years.
How does the process work?
Andrea Hofelich, director of media relations for the Generic Pharmaceutical Association, said when a company is interested in making a generic form of a brand-name drug, it files an “abbreviated new drug application” with the FDA.
The process is abbreviated because in most cases, clinical trials are not required. The thinking is that the brand-name drug has been on the market long enough — patents typically are for 20 years — and has proved to be effective and safe.
The generic drug must be “bioequivalent”: It must contain the same active ingredient and be identical in strength and dosage, among other requirements.
Generics are as effective as brand-name drugs, said Dennis Grauer, the interim chairman of the pharmacy practice department at the University of Kansas.
Does your drug have a generic?
The easiest way to find out is to ask your doctor or pharmacist, the Generic Pharmaceutical Association says.
You also can use an online resource such as the U.S. Food and Drug Administration’s “electronic orange book” at www.fda.gov/cder/ob.
To use it, first search by brand name to find the active ingredient in the drug. Then search by the active ingredient: The generic drug manufacturers will be listed beside the brand name manufacturer.
Upcoming generics
These brand-name drugs are expected to become generic in coming years (year indicates when brand-name drug’s patent expires):
Coming in 2007: Aceon, Actiq, Alocril, Clarinex, Coreg, Geodon, Imitrex, Lotrel, Mavik, Meridia, Norvasc, Tequin, Zyrtec.
In 2008:Advair, Camptosar, Casodex, Depakote, Dovonex, Effexor XR, Fosamax, Kytril, Risperdal, Serevent, Trusopt, Zerit, Zymar.
In 2009: Acular, Avandia, Avelox, Glyset, Lamictal, Topamax, Valtrex, Vexol, Xenical.
Source: Generic Pharmaceutical Association, www.gphaonline.org