Claritin OTC sales sought
Schering-Plough seeks FDA approval of non-prescription sales for allergy drug.
March 8, 2002: 1:00 p.m. ET
By Staff Writer Chris Isidore
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NEW YORK (CNN/Money) - Schering-Plough Corp. said Friday that it had filed for permission to sell its key drug, allergy remedy Claritin, as an over-the-counter medication.
Shares of Kenilworth, N.J.-based Schering-Plough (SGP: down $1.86 to $34.10, Research, Estimates) fell about 5.5 percent after it filed for non-prescription status.
The drugmaker said it hoped to have permission from the U.S. Food and Drug Administration to switch from prescription-only sales of the drug by Nov. 28.
Claritin had sales of $3.2 billion in 2001, representing 38 percent of Schering-Plough's total revenue for the year. The company had relatively modest over-the-counter drug sales of $196 million last year, far behind not only its prescription drug sales but also nearly the $1 billion in sales of its sun protection and foot care products under the Coppertone and Dr. Scholl's brands.
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A newer version of Claritin, Clarinex, went on sale earlier this year, but initial reports are that it still has only a fraction of Claritin's sales. Schering-Plough said it would expect Clarinex to take Claritin's place as the prescription treatment of allergies.
"With the market introduction of Clarinex...moving Claritin to over-the-counter status would give Schering-Plough an opportunity to establish brand leadership in both the prescription and OTC categories," said a statement from Schering-Plough President Richard Zahn.
The issue of Claritin's status is set to be considered at a meeting in late April of the FDA's Nonprescription Drugs Advisory Committee, according to Schering-Plough's statement. The company said that committee, together with the FDA's Pulmonary-Allergy Drugs Advisory Committee, made a non-binding recommendation in May 2001 that the drug has a safety profile acceptable for OTC marketing.
Schering-Plough faces loss of some its patent protections on Claritin as soon as later this year, although the company said that some of the patents involving the drug extend through 2012.
"Schering-Plough believes its patents for Claritin are valid and enforceable, and it intends to continue with a vigorous prosecution of challenges to its Claritin-related patents," said the company's statement.
The company Friday also reiterated its previous earnings guidance. It said a switch of Claritin to over-the-counter status would not materially affect this year's results since it likely would not take place until late in the year. 
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