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Going generic

Going generic

As brand-name drugs lose patents, everybody saves

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WICHITA, Kan. — Judy Beals doesn't have to take a lot of medications, but when she does need medicine, she tries to get the generic form. She has no qualms about straying from the brand name. "I don't pay nearly as much," the Wichita, Kan., 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 for depression and anxiety, Zocor for cholesterol, Zoloft for depression and anxiety, and oral suspension of Zithromax, an antibiotic for children. (For a full list, go to www.fda.gov/cder/ogd/approvals).

That number compares with 47 new generics for the same period during 2005 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 each other. In addition to first generics, the FDA has approved dozens of applications this year from companies wanting to offer generics already on the market.

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.

Michael Polzin, a spokesman for Walgreens, said about 60 percent of prescriptions filled by the chain are generics.

"That's ticking up a couple percent every year," he said.

Consumer's Pharmacy owner Ed Boyd says 99 percent of his customers prefer generic when available.

He follows suit.

"I take a generic if it's available, and I give it to my parents if it's available," Boyd said.

Use of generics grows

Generic drugs represented 66.4 percent of prescription doses sold in 2004, compared with 61 percent in 2001, Scott Gottlieb, deputy commissioner for medical and scientific affairs for the FDA, said 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 what's called "bioequivalent." It must contain the same active ingredient and be identical in strength and dosage, among other requirements.

About 770 generic applications were pending by the end of fiscal year 2005.

The association says it is concerned about a backlog of applications at the Office of Generic Drugs, which processes applications.

Gary Buehler, director of the office, told a Senate committee in July that the number of applications had increased by 150 percent during the past five years.

Since fiscal year 2001, funding for the FDA's generic drug program had increased by 66 percent, "a clear sign of the important role played by OGD," he said.

Effective and cheaper

Boyd, the owner of Consumer's Pharmacy, said he has a few customers who shy away from generic drugs, "bite the bullet" and pay for the brand name.

Generics are as effective as brand-name drugs, Dennis Grauer, the interim chairman of the pharmacy practice department at the University of Kansas, said last week while discussing a plan by Wal-Mart to offer 30-day supplies of 291 generic drugs to consumers for $4 each.

Boyd said his pharmacy won't automatically fill a prescription with a generic drug unless "we know the patient wants it. We know most of our customers pretty well and can tell by looking at their profile if they like the generic."

People definitely pay the price for demanding brand names, he said.

"Most of the insurance companies are really going to sock it to them on their co-pay," he said.

Everyone saves

Blue Cross and Blue Shield of Kansas, the state's largest insurer, has three co-payment tiers for prescription drugs.

There's a co-payment for generic drugs, a co-payment for brand-name drugs on Blue Cross and Blue Shield's formulary and a co-payment for brand-name drugs not on the formulary.

A formulary is a list of drugs "that we have seen and viewed as the best drugs in those classifications that are reasonably priced and efficient for the disease or condition that they're prescribed for," said corporate communic ations manager Mary Beth Chambers.

The most expensive co-payment is for brand-name drugs not on the formulary.

"As generics come on to the market, we certainly look at ways to encourage people to move to the generic drug," Chambers said.

As an example, Blue Cross and Blue Shield may move a drug from the brand-na me formulary to the non-formulary to encourage customers to use generic.

Many companies do that, she said.

"In the long run, generics save everyone money," Chambers said. "The member is going to pay less for a co-payment. The insurance company is going to pay less for the amount we reimburse to the pharmacy, which helps us hold the line on premium costs."


Upcoming generics

These brand-name drugs are expected to become generic in coming years (name of brand-name drug and when its patent expires):

• Aceon, Feb. 2007

• Actiq, Feb. 2007

• Acular, Nov. 2009

• Advair, Aug. 2008

• Alocril, April 2007

• Avandia, Feb. 2009

• Avelox, Dec. 2009

• Camptosar, Feb. 2008

• Casodex, Oct. 2008

• Clarinex, 2007

• Coreg, Sept. 2007

• Depakote, June 2008

• Dovonex, June 2008

• Effexor XR, June 2008

• Fosamax, Feb. 2008

• Geodon, Sept. 2007

• Glyset, July 2009

• Imitrex, June 2007

• Kytril, June 2008

• Lamictal, Jan. 2009

• Lotrel, Jan. 2007

• Mavik, Dec. 2007

• Meridia, Dec. 2007

• Norvasc, Jan. 2007

• Risperdal, June 2008

• Serevent, Aug. 2008

• Tequin, Dec. 2007

• Topamax, March 2009

• Trusopt, Oct. 2008

• Valtrex, Dec. 2009

• Vexol, Jan. 2009

• Xenical, Dec. 2009

• Zerit, Dec. 2008

• Zofran, Dec. 24, 2006

• Zymar, June 2008

• Zyrtec, Dec. 2007

Source: Generic Pharmaceutical Association, www.gphaonline.org


Now you know

Does your drug have a generic?

Wondering if a drug you take is available in a generic form?

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," which lists drugs, 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.

For example, check out Zoloft, a medication for depression and anxiety.

The Web site shows that the active ingredient is sertraline hydrochloride.

Then looked up that ingredient to find the generics.

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