All you need to know about these off-patent pills
By E.J. Mundell
HealthDay Reporter
THURSDAY, Jan. 5 (HealthDay News) -- Many Americans know that generic drugs are cheaper than brand-name versions. Beyond that, many people may have questions -- such as, What exactly are these cut-price pharmaceuticals, anyway?
"They're what we call 'bio-equivalents' -- they have the same active ingredient in the same amount as brand-name versions. They offer the same delivery, too," explained Douglas Hoey, a pharmacist and senior vice president for practice affairs at the National Community Pharmacists Association, representing community drug stores across the United States.
Hoey stressed that all generic medicines made and sold in the United States are FDA-approved. "That means they have the same safety and efficacy profile as the brand-name drug," he said.
All things being equal, then, most consumers who pay for drugs out-of-pocket would probably prefer the cheaper, generic option when filling their prescription. Hoey said that, typically, "the average cost of a brand prescription runs about $85, while the average cost of a generic prescription is about $25 -- so it can be a big difference."
He stressed that although most generics offer this level of savings over brand-name drugs, a minority may not. So consumers shouldn't be surprised if a particular drug is only slightly cheaper in its generic form.
The journey from a drug being discovered in the lab to its later life as a generic on pharmacy shelves can be a long one, since drugmakers typically get exclusive rights to any patented compound for 20 years after that patent is approved, Hoey said.
"But remember, the clock starts ticking the day that patent approval comes through," he said. Since it can take another three, five or even 10 years for a patented drug to wind its way through the FDA approval process, the actual "on-market" life span of patents for many brand-name drugs can be less than a decade, he said.
Some pharmaceutical blockbusters have already lapsed into generic status. The anti-cholesterol drug Mevacor (lovastatin) has long been generic, Hoey said. And a related medication, Pravachol (pravastatin), recently lost its patent, too. On the other hand, Pfizer's cholesterol-lowering Lipitor doesn't lose its patent protection until about 2009, Hoey said.
Then there's the class of popular antidepressants called selective serotonin reuptake inhibitors (SSRIs). Some of these medicines, such as Prozac, have been available in generic versions, while mega-selling Zoloft is set to go off-patent next year, according to Hoey.
In contrast, Celebrex -- the remaining cox-2 inhibitor painkiller on the U.S. market -- "has a lot of time left" on its patent, he said.
Consumers may notice that a particular drug's price doesn't automatically plunge as the first generic version hits the market. That's because one drugmaker usually gains exclusive rights to market a generic version during a six-month window just after the patent expires.
"After that though, it's wide open," Hoey said -- and that's when prices can really start to tumble.
He noted that in many cases, consumers who get their insurance through an employer's health plan may notice they still receive more expensive, brand-name drugs even after generics become available. That's because many plans buy their drugs through "pharmacy benefit manager" companies that, in turn, are offered rebate incentives by pharmaceutical companies to stick with brand-name versions. "It's a very convoluted process," Hoey said.
He did offer up one note of caution for consumers: "If your generic drug looks different [than a previous generic prescription], be sure and ask your pharmacist. Because from one generic manufacturer to another the tablet might be white or blue, for example.
"That's OK, but -- especially if you're getting them from a mail-order service -- it could be a mix-up, too," Hoey said. "So if you get a different-colored medication, don't hesitate to check with a pharmacist before you take it. These drugs aren't Pez candy -- take them seriously, and if you have questions, ask."
SOURCE: Douglas Hoey, R.Ph, senior vice president, practice affairs, National Community Pharmacists Association, Alexandria, Va.
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