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NEW YORK–The blockbuster Claritin allergy remedy finally reached OTC store shelves earlier this month courtesy of Schering-Plough, promising to shake things up a bit in the cough-cold aisles.
And already the competition is gearing up to join the loratadine race. If all goes as planned, Wyeth will begin shipping its own OTC loratadine formulation, Alavert, within a day or two of the expiration of Schering-Plough’s patent Dec. 19. Wyeth is awaiting final Food and Drug Administration approval, which cannot be granted until the patent expires. McNeil Consumer Healthcare also has a pending new drug application for marketing loratadine OTC, but declined to comment on when the company would actually bring such a product to market. And Perrigo was showing retailers a version to which chains could attach their own brands last month, at the Private Label Manufacturers Association conference in Chicago (for more see story, page 4).

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Schering-Plough, however, got out of the gates first with five Claritin SKUs, all at original prescription strength, making Claritin the only OTC antihistamine to offer non-drowsy allergy relief-that is, for at least a week. The five SKUs include Claritin tablets, a once-daily formulation; Claritin RediTabs tablets, a once-daily dissolving. tablet; Claritin-D 24-Hour Extended Release tablets, with the decongestant pseudoephedrine sulfate; Claritin-D 12-Hour Extended Release tablets; and Claritin Syrup for children.
Although no specific details have been divulged related to marketing plans for any of the new OTC loratadine brands, both Schering-Plough and Wyeth indicated their support would be significant. And Pfizer, which markets current OTC allergy champ Benadryl, maintained its plans to strongly support its brand post-switch.
Even with all the hoopla surrounding the switch of loratadine, Pfizer figures its market dominance won’t change anytime soon. Citing a study the company commissioned, conducted by ACNielsen BASES, Benadryl senior product manager Enrique Alonso noted, “We know Benadryl allergy users will continue to be loyal to the brand; the product is proven to be more effective than Claritin at relieving. [the] worst allergy symptoms.” According to the research, the largest percentage of Claritin’s OTC volume is projected to come from former prescription Claritin users, with minimal impact to the Benadryl brand.
While Claritin is expected to grow total retail dollar sales in the OTC cold-allergy-sinus category 7 percent, the study theorizes that Benadryl would still maintain its leadership position in the OTC marketplace.
Of course, that is not the way OTC loratadine marketers size up the situation. While the launch of OTC loratadine definitely figures to grow the overall size of the category, it also stands to erode at least somewhat the share of the OTC allergy product that dominated the category prior to the switch, including Benadryl, Wyeth Consumer Healthcare spokesman Fran Sullivan explained. “We believe that once [loratadine] goes over the counter, the market is going to expand,” Sullivan said. But, “people who are currently using first-generation antihistamines are going to move over to a loratadine product because it’s non-sedating.”
Retailers’ preparations
No matter, retailers have been preparing for the biggest switch to hit the OTC aisles since H-2 blockers and smoking cessation products switched in the mid-1990s. Walgreens e-mailed all interested customers a discount offer to pre-order Claritin the week before it hit shelves, offering 20 tablets for $20.
Rite Aid, through its partnership with drugstore.com, also offered pre-order opportunities, selling packets of five tablets for $5.99. In addition, Rite Aid promoted the allergy launch with a coupon in its circulars the week Claritin was released and via e-mail for customers who signed up for the chain’s single-check rebate program. In addition, Rite Aid distributed Claritin bagstuffers ealier this month.
CVS began carving out four 3-foot shelving units at eye level in its allergy section as early as September, holding that space with a smattering of facial tissue offerings alongside a “coming soon” sign, heralding, “non-drowsy allergy relief.”
And Eckerd promoted the OTC Claritin launch with a “coming soon” teaser in its Nov. 24 and Dec. 7 circulars.
There is still an outside chance that Wyeth, McNeil and several generic drug manufacturers will not be allowed to compete with Claritin OTC in the near future. Earlier this year, Schering-Plough sued a number of companies that had a loratadine application pending with the FDA, arguing that its patent protection actually extended through 2004.
However, the U.S. District Court of New Jersey in August ruled against Schering-Plough. The company appealed the decision, and that appeal is pending still. But that won’t stop at least Wyeth from joining the race. Wyeth now holds an approval letter from the FDA. “When we get final approval, we’re out the door with 24-packs, Sullivan said.
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