Schering-Plough is offering consumers free samples of Claritin through a new Web site that became operational shortly after the drug's OTC approval.

"Free samples of Claritin will be available in early 2003," says the Web site, ¹ www.claritin.com, which invites visitors to "reserve your free sample now." The site also urges consumers to look for a $1-off coupon on Claritin products in newspapers Dec. 15.

In addition to brief product information about all five Claritin formulations, the site contains an "Allergy Library," with ways to distinguish allergies from colds and tips for coping with allergies.

Under the section "Is Claritin Right for Me," the site states: "If you suffer from concomitant conditions such as asthma, chronic sinusitis or otitis media, then you should talk to your physician about treating allergies."

Following FDA's Nov. 27 approval of the Rx-to-OTC switch of the antihistamine franchise, Schering announced plans for "a multi-faceted educational program focusing on allergies, allergy management and potentially associated conditions, such as asthma" (² Also see "Schering OTC Claritin Post-Approval Filings To Include Hypospadia Reports" - Pink Sheet, 2 December, 2002., p. 3).

OTC versions of four Claritin products - 10 mg tablets, RediTabs, syrup and Claritin-D 24-Hour - are expected to begin appearing on store shelves the week of Dec. 8. Nonprescription Claritin-D 12-Hour will not be available until early 2003, Schering said.

Under an agreement announced in June, Impax Labs will manufacture Claritin-D 12-Hour for Schering (³ Also see "Impax, Schering Patent Litigation Continues Despite Claritin-D Agreement" - Pink Sheet, 1 July, 2002., p. 4).

However, Impax' ANDA for the loratadine/pseudoephedrine combination is awaiting final FDA approval, which is expected soon after the Dec. 19 expiration of the loratadine compound patent. The generics maker holds "first-to-file" status for the 12-hour formulation.

Wyeth is preparing to launch Alavert , its equivalent to Claritin RediTabs, "within days" of FDA approval, which is expected on or shortly after Dec. 19. Wyeth initially will roll out the product in 24-counts, later introducing six-, 12- and 48-count sizes.

Alavert, which will feature CIMA Labs DuraSolv technology, will be "heavily promoted and advertised," according to Wyeth, which holds first-to-file status for orally dissolving loratadine and also has a pending 505(b)(2) application for the product.

Other first-to-file ANDA holders include Geneva (10 mg tablets), Teva (syrup) and Andrx (D 24-Hour). Geneva is a Novartis subsidiary, and has a licensing and supply agreement with CIMA for a RediTabs equivalent. McNeil Consumer & Specialty Pharmaceuticals also has a 505(b)(2) application pending for 10 mg loratadine tablets.

The winter months are likely to feature a frenzy of consumer advertising by Schering, retailers and marketers of competing loratadine products.

In The Washington Post Dec. 5, retailer CVS ran a half-page ad featuring OTC Claritin and telling consumers they can "find it first at CVS/pharmacy next week."

Drugstore.com is allowing consumers to pre-order Claritin; a 20-count of 10 mg tablets is priced at $19.99, while 10-counts of RediTabs and D 24 sell for $12.99 each. Walgreens also is offering consumers the opportunity to pre-order and is running radio and TV ads (⁴ Also see "OTC Claritin $1 Per Tablet Pre-order Price Listed On Walgreens Web Site" - Pink Sheet, 2 December, 2002., p. 4).

However, the marketing push also is expected to include advertising by current OTC allergy remedy makers who will be fighting to maintain market share despite Claritin's much-ballyhooed entry.

For instance, Benadryl marketer Pfizer issued a press release Nov. 27, prior to the announcement of Claritin's OTC approval, stating that Benadryl "will continue its market leadership even after Claritin becomes available without a prescription." Pfizer cited research by ACNielsen and BASES, a primary consumer research company.

In the cold/allergy/sinus liquids/tablets category, the Benadryl franchise recorded sales of $166.6 mil. in food, drug and mass outlets (excluding Wal-Mart) for the 52 weeks ended Nov. 3, according to Information Resources, Inc. (Chicago). Dollar sales were flat compared to the year-ago period, while unit sales were down 2.3% to 30.1 mil., the IRI data show.

In a likely preview of Schering's consumer advertising approach, the Claritin Web site features a chart comparing the non-sedating antihistamine with other OTC allergy brands, including Benadryl and Schering's own Drixoral , with regard to dosing, drowsiness warnings and driving restrictions.

Schering OTC Claritin Coupons Appearing In Newspapers Dec. 15

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