Claritin 12-Hour Takes Aim At Shorter-Duration Allergy Drugs

Schering-Plough extends the Claritin line into the 12-hour allergy relief niche to go after first-generation antihistamines with shorter durations.

The company announced Sept. 1 the launch of Claritin 12-Hour RediTabs , calling it "the only 12-hour allergy medicine found in the allergy aisle." The launch debuts the firm's 5-mg dose of loratadine, which FDA approved in 2006 but Schering did not market until now.

Other 12-hour oral remedies for allergies, including Claritin-D 12-Hour, contain pseudoephedrine and must be sold behind store counters.

Schering's initial marketing for Claritin 12-Hour goes after allergy drugs that offer smaller windows of relief, including Johnson & Johnson's Benadryl (diphenhydramine) and Tylenol Allergy line, which includes diphenhydramine and chlorpheniramine as active ingredients. While dosing instructions vary by product, most work in a four- to six-hour range.

It is not clear whether 5-mg Claritin will have a distinct advantage in an effort to appeal to consumers who use the shorter acting drugs, with both private-label and branded versions of 24-hour loratadine (10 mg) well-established.

But Kenilworth, N.J.-based Schering touts the convenience of the quick-dissolve RediTab format and the flexibility offered by 12-hour relief.

The firm also appears to view the older end of the pediatric allergy market as a potential niche for the lower-dose offering.

The non-drowsy antihistamine is "convenient for moms looking to give their kids all-day allergy relief, while allowing the flexibility to re-dose at night, if needed," Schering says in its release.

Like 24-Hour RediTabs, the 12-hour version is indicated for use in children 6 years and older.

Rebecca Piltch, an allergist with a private medical practice in San Rafael, Calif., notes that the convenience offered by the lower dose of RediTabs should not be underestimated.

Compared to Children's Claritin syrup, the dissolving tablets are "easier to carry around and may be more convenient," she said in an interview. "And convenience is an important factor in on-the-ground decisions that patients and parents make."

However, another doctor sees little practical benefit in Claritin 12-Hour RediTabs, for children or adults.

Allergist Neil Kao suggests parents split a 10-mg RediTab to give their children a 5-mg dose - an off-label approach.

"It's like trying to cut a marshmallow in half," said Kao, of the Allergic Disease & Asthma Center practice in Greenville, S.C. "There's just nothing to it, you can do it with your fingernail, practically."

For an adult taking a 12-hour RediTab compared to the 24-hour dose, "there would not only be no benefit, but they'd actually potentially not get enough antihistamine to either get relief immediately or they could run out of protection later during the day," he said.

But Schering says there is an unmet consumer need for Claritin 12-Hour, citing a 2007 tracking study the research group Millward Brown conducted for the firm, which found "34 percent of allergy sufferers want something in between" six-hour products and those indicated for 24 hours.

A marketing manager for Millward Brown said the figure came from the survey question "When you take an allergy medication, for how many hours do you want it to last?" Possible answers were "up to" four, eight, 12 or 24 hours. The group declined to share percentages for the other options, or other questions asked in the study.

A TV ad for the product shows a woman climbing a mountain, aided by Claritin 12-Hour, which "works all day so I can make it to the top," she says.

Another woman stalls on her climb after getting only four to six hours of allergy relief that the ad says would be provided by either Benadryl or Tylenol Allergy.

The Crowded Allergy Market

Even though Claritin sales have been dogged by generic equivalents since the product switched to OTC in 2002, the 12-hour line extension does not appear to be geared toward gaining market share back from private labelers or toward winning over price-oriented consumers (¹ (Also see "A Lesson In Exclusivity? Claritin Falters As Generic Loratadine Sales Double" - Pink Sheet, 16 May, 2005.)).

Schering did not provide a suggested retail price, but a 30-pack of Claritin 12-Hour RediTabs sells for $22.99 on drugstore.com. A 60-pack of Rite Aid store-brand loratadine 10-mg tablets is $16.49 on the same site.

The overall Claritin brand has 21.5 percent of the U.S. antihistamine market, according to Euromonitor International. Only J&J's Zyrtec (cetirizine hydrochloride), with 25 percent of the segment, and private-label products, with 24.5 percent, sell more.

Claritin RediTabs, however, comprise a small slice of the cold/allergy/sinus remedy market, representing only 1.5 percent of sales, or $38.3 million, during the 52 weeks ended Aug. 9, according to Information Resources Inc. data for supermarkets, drugstores and mass merchandise outlets, excluding Wal-Mart.

RediTab sales declined 18.2 percent year-over-year during that period, IRI says.

Delayed Introduction

Schering received FDA ² approval for Claritin 12-Hour RediTabs in December 2006, accompanied by a request that the firm revise proposed labeling to more clearly distinguish the 12-hour and 24-hour versions.

While Schering was given 180 days to make the change, it did not submit a supplemental new drug application with the revised label until June 2008. FDA subsequently ³ approved the SNDA in October 2008.

A spokeswoman acknowledged the 2006 approval but declined to discuss why Schering waited years before launching Claritin 12-Hour.

Laura Mahecha, health care industry manager for market researcher Kline & Co., posited that Claritin 12-Hour, short of meeting a clear-cut consumer need, may be a means to filling drugstore shelf space and "a way to maintain trade relations" with retailers anxious for new products and promotions.

The new RediTabs SKU launched around the same time as Claritin Eye (ketotifen fumarate), which also claims 12 hours of relief from allergy-related eye itchiness (⁴ (Also see "Claritin, Zyrtec And Visine Products Flood Eye Drop Market" - Pink Sheet, 31 Aug, 2009.)).

Mahecha additionally suggested that Merck management might have come in and encouraged Schering to push out an approved product that was languishing (see story p. 8).

- Dan Schiff ( ⁵ [email protected] )