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Ad blitz on for Claritin alternative

As the patent for the popular allergy drug nears expiration, its makers begin a hard push for Clarinex. Some question whether the new drug will offer benefits to justify its higher cost.

By WES ALLISON, Times Staff Writer
© St. Petersburg Times
published April 17, 2002

In the past 10 years, Schering-Plough Corp. has spent hundreds of millions of dollars making Claritin one of the nation's most advertised and bestselling drugs, pitching it as an effective allergy solution with minimal side effects.

Never mind all that. Now Schering needs you to know about Clarinex.

With Claritin scheduled to lose its patent protection this year, opening the door to cheap generic versions, Schering has begun bombarding the airwaves with ads and free trial offers for its newest incarnation, Clarinex.

Clarinex is a derivative of Claritin and works the same way. Although no studies have been done to show whether it's superior, Schering hopes to persuade patients and doctors to switch to Clarinex during the next eight months, before Claritin's patent expires and the price drops as much as two-thirds.

Meanwhile, the company has asked the U.S. Food and Drug Administration for permission to sell Claritin without a prescription. That would prevent Clarinex from having to compete with cheaper generic Claritin and would allow Schering to keep trading on the popular brand name.

Pharmaceutical analysts say it's a clever two-pronged strategy, though it may prove difficult to execute. Critics complain it's an example of how drug companies contribute to the rising cost of prescription drugs by manipulating the market, and they warn consumers to beware paying more for a drug that may not deliver more.

"This is not about improved medical care. This is about money," said Larry Levitt, vice president of the Kaiser Family Foundation, a nonprofit health care research organization.

"The problem is the average consumer sees the ads on TV and finds it very difficult to make sense of what's going on here," he said. "It's a new drug -- must be better, right?"

For Schering, the stakes are enormous: Claritin boasted U.S. sales last year of $2.7-billion, accounting for a whopping 28 percent of the company's revenues. Global sales amounted to $3.1-billion.

Typically, sales of a brand-name drug fall 50 to 75 percent in the year after a generic version becomes available, thanks to lower prices and health plans that generally require pharmacists to dispense generics.

Amy Arnott, a pharmaceutical analyst and managing editor at Morningstar Inc., said Schering needs something to plug that hole.

"They're facing a huge loss of revenue," she said. "The strategy is to come out with a new and improved version of the product and convert people to that before the Claritin goes off-patent.

"It's a good strategy if you do have a drug that is actually meaningfully better. The advantages, if any, of Clarinex are very incremental. It's definitely not a major improvement."

Schering has told investors it plans to make Claritin the premier over-the-counter allergy medication while making Clarinex the leading prescription brand. The company launched its "Clarinex DTC (direct-to-consumer) Education Program" last month with broadcast and magazine ads, and TV ads recently began running in the Tampa Bay area. None of the ads even mention Claritin, but Arnott said it's no coincidence the names are so similar.

Physicians are being invited to Clarinex informational seminars, and Schering sales representatives have begun replacing free samples of Claritin with free samples of Clarinex.

Clarinex also is priced about 18 percent lower than Claritin, and patients can get a coupon for a free week's supply from the product's Web site,

Another promotion offers a 10-day supply to patients who complete a survey about how well the drug works. Schering sends those survey results to the patient's doctor, as a way to show the drug works.

"I'm finding that it's working probably just as well as Claritin," said Dr. Steven G. Weiss, an allergist-immunologist in Clearwater. "We're always somewhat excited (with new options) because it's another tool we have in our bag, so to speak, for treating allergic patients."

Weiss typically gives patients samples of the leading allergy drugs, including Allegra, Zyrtec and, now, Clarinex. Then they can determine which works best for them, he said. "If a patient tries Clarinex and it gives them that much of an edge over Claritin, so be it."

Making it last

Drug companies often try creative approaches to eke new sales life out of popular old drugs, known in the industry as "brand evergreening." They frequently challenge the patent expiration dates, and sometimes gain months or years simply by tying the matter up in court.

Claritin hit the market in April 1993, although it was patented back in 1986, when the patent life for drugs was 17 years. Six generic drug manufacturers have won tentative FDA approval to make Claritin, known generically as loratadine, when the patent expires in December.

Even as it pushes Clarinex, Schering has filed a federal lawsuit in New Jersey seeking to extend its patents. The company maintains Claritin and Clarinex are two distinct products, but it also argues Claritin should be protected under patents for Clarinex.

Schering spokesman William O'Donnell declined to explain the dichotomy.

"I can't get into patent strategy. That's just our position," he said. "There have been companies who filed (FDA papers) that seek to market generic forms of loratadine. We have challenged them."

Rebranding is common as well. When Eli Lilly & Co. failed to keep Prozac, the antidepressant, protected by patent last year, Lilly repackaged the drug as Serafem and began marketing it to women for a condition called premenstrual dysphoric disorder, a severe form of premenstrual syndrome.

WellButrin, an antidepressant by GlaxoSmithkline, got new patent protection as Zyban, a smoking cessation aid.

Doctors could prescribe the cheaper generic versions of both, but patients often ask for brand names that are advertised to treat a specific condition, recent reports by Harvard University and the Kaiser Family Foundation found.

In the meantime, the FDA is expected to rule in November on Schering's application to sell Claritin without a prescription.

Claritin now costs about $200 for a 90-day supply. If it sells over-the-counter, Schering would have to cut the price drastically to compete with other nonprescription allergy pills, Arnott said.

But the move would allow Schering to build on Claritin's impressive brand name in the over-the-counter market and may attract new customers who don't want to bother with seeing a doctor or who need allergy medicine only occasionally.

Schering is not alone in offering a slightly different drug just as the patent for the old version expires. AstraZeneca is pitching Nexium, an anti-ulcerative billed as "the purple pill," as a replacement for Prilosec, the company's $4.6-billion bestseller.

To win FDA approval for Clarinex, Schering did not have to show it's better than Claritin, only that it's safe and effective for the treatment of allergic rhinitis. But ads do point to differences: Clarinex is indicated for indoor and outdoor allergies, and one pill is said to last 24 hours. Claritin is indicated only for outdoor allergies -- though many doctors say they do not differentiate -- and only Claritin D-24 offers 24-hour protection.

Dr. Dennis Ledford, an allergist-immunologist at the University of South Florida and James A. Haley Veteran's Hospital in Tampa, participated in Clarinex clinical trials and says it does offer some chemical advantages: Clarinex has a half-life of 26 hours, compared with nine hours for Claritin, meaning it stays in the body longer. It also blocks histamines more effectively.

That means it's more potent. However, it's not clear whether that translates into a substantially better treatment, he and Weiss said. No studies have compared Clarinex to Claritin, and Schering is not likely to sponsor any, analysts say.

"Claritin clearly works. It's an effective medication that is nonsedating," Ledford said. "If Clarinex is a little better, but it costs a lot more, is it worth it? That's a value judgment."

Insurance companies are considering that now. Increasingly, managed care plans are reluctant to cover expensive new medications that offer few benefits to older, less expensive versions, especially if generics are available.

Last year, the average brand-name drug cost $65 for a 30-day supply; the average generic cost just $19.

Even if health plans cover Clarinex -- Schering and some analysts think they will -- they're likely to put it in a special category, or tier, that requires a larger co-payment.

In realm of drug marketing, Claritin holds a special place. It was among the first drugs actively promoted when the FDA relaxed advertising regulations in 1997, and it quickly hit the top of the sales chart.

Although advertising for Claritin dropped last year, the company spent more than $110-million in 1999 and again in 2000 to promote it to consumers.

Tens of millions of Americans sneeze at cats and oak pollen, or sniff in the presence of dust mites or mold, and Schering has proven quite adept at getting their attention. Which is why Mike Krensavage, a pharmaceutical analyst at Raymond James & Associates who follows Schering-Plough, said he thinks Clarinex ultimately will enjoy "some decent staying power."

"The questions I'm getting . . . are very logical questions: How can the drug really grab market share when it apparently doesn't offer significant advantages to Claritin?" Krensavage said. "The answer is marketing."

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