Claritin about to join over-the-counter mix

NEW YORK — The wildly popular allergy medicine Claritin will be available over the counter by mid-December, a boon to insurers, a blow to the manufacturer and a convenience to consumers.

The switch, approved yesterday by the Food and Drug Administration, will save the government, employers and health insurers at least $1 billion a year because nonprescription drugs aren't covered by insurance.

But while Claritin will be more affordable for millions of people without insurance coverage, a few may actually pay more. A month's supply now costs between $80 and $95 by prescription, and although manufacturer Schering-Plough Corp. wouldn't comment on price yesterday, it is expected to drop to $17 to $20, about the same or slightly more than the typical drug copayment.

The move, requested by Schering-Plough after the company initially opposed it, is unique in the pharmaceutical industry because it was precipitated by health insurer WellPoint Health Network, which has spent $40 million on Claritin this year. Acting on a petition by the Thousand Oaks, Calif.-based insurer, an FDA panel said last year that Claritin, Pfizer's Zyrtec and Aventis' Allegra were safe enough to be sold over the counter.

Besides that ruling, Schering-Plough also faced moves by generic firms and other pharmaceutical companies to introduce their versions of Claritin after the medicine's major patent expires Dec. 19.

"This is Schering-Plough making the best of a bad situation," said Lehman Brothers analyst Trevor Polischuk.

Claritin accounts for about $2.7 billion of the $4 billion U.S. market for prescription non-sedating antihistamines.

Worldwide sales last year generated $3.2 billion — almost a third of Schering-Plough's total revenues. Experts estimate that revenues from over-the-counter sales will drop to about $400 million.

In 2001, Schering-Plough introduced Clarinex, a successor to Claritin, in a bid to extend the franchise. The two drugs are similar, and even though Clarinex is less expensive than its predecessor, it hasn't created the same loyalty or sales.

Now Schering-Plough faces a huge marketing challenge: creating a demand for its over-the-counter product while still expanding the prescription market for Clarinex.

Consumers will have to weigh price vs. convenience.

Theresa La Padula, 25, of Hoboken, N.J., is thrilled she won't have to go to the doctor anytime she needs a refill, but she said she would get a prescription for Allegra if over-the-counter Claritin cost significantly more than her $10 copay.

Competitive pressures also are involved.

Wyeth, Johnson & Johnson and various generic companies have filed applications with the FDA to sell generic Claritin, and Wyeth said it plans to launch its version, Alavert, on Dec. 20. The company wouldn't discuss pricing.

In August, a federal judge ruled that Wyeth and four other companies didn't infringe on a separate Claritin patent that expires in 2004. Schering-Plough is appealing, but Wyeth is introducing its product anyway.

Analysts said prescription sales of Clarinex, Allegra and Zyrtec are likely to suffer as patients self-medicate, insurers drop coverage and doctors offer over-the-counter medicines before writing prescriptions.