Report predicts potential OTC status for more than a dozen Rx drugs

NEW YORK There are 14 prescription drugs that exceeded $20 billion in sales in 2006 that may have the potential to reach the over-the-counter market in four years, according to a report from Kalorama Information, released Thursday.

The markets for Rx-to-OTC switch products are forecast to reach $5 billion in 2008 and increase by close to 40 percent by 2010. More than half of the revenues in 2008 will be from allergy medications that have already made the switch, such as Claritin, Benadryl, Sudafed, Nasalcrom, Mucinex and most recently Zyrtec. However, the forecast compound annual growth rate from statin switches between 2008 and 2013 far outpaces that of the allergy category (127.5 percent versus 3 percent).

“Lagging FDA approvals led to a brief absence of Rx-to-OTC switches in the pharmaceutical marketplace, but 2006 and 2007 saw a number of switches,” noted Melissa Elder, the report’s author. “We believe this product management tactic will continue to be aggressively utilized as companies seek ways to extend revenue lifecycles.”

Factors affecting this recent upswing in Rx–to-OTC switches include patent expirations, generic competition, suitability for OTC shelves, drug safety and efficacy, petitions to the FDA and manufacturer trends. Some future potential switches include leading gastrointestinal drugs Prevacid, Protonix and AcipHex; antilipidemic agents Mevacor, Pravachol, Lescol and Zocor; the allergy treatment Allegra; the migraine therapy Imitrex, and a number of oral contraceptives.