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FDA Peers Over the Counter

By early 2002, "after losing a protracted patent litigation," Schering-Plough changed its view, said the Tufts Center for Drug Development. "To expand the brand name's viability," Schering-Plough sought and received FDA approval for OTC Claritin.

OTC Claritin "represents an important new treatment option for the estimated 20 million Americans who currently choose to treat their allergies with a non-prescription medication," Schering-Plough said in November 2002 news release, after the FDA approved the drug. Claritin went over the counter shortly after Schering-Plough introduced a cousin, Clarinex, to the prescription market.

Neither Merck nor Bristol-Myers has said much about turning their cholesterol drugs into OTC products. Mevacor has long since lost patent protection; its U.S. sales are being swamped by generic competitors. Pravachol loses U.S. patent protection in April 2006. It is the third-ranked drug in the statin class of cholesterol drugs. Pfizer's (PFE) Lipitor is the leader, followed by Merck's Zocor, which loses its U.S. patent in mid-2006.

Zocor is the world's first statin to be switched to OTC status, having reached U.K. pharmacies in July. "In general, the switch has been well-received in the U.K.," said Paula Fryans, senior cardiovascular analyst for Datamonitor.

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