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Last updated on Thursday, May 29, 2014
(UNDATED) - Eli Lilly and Company and France-based Sanofi have announced they will purse regulatory approval to sell Cialis over the counter.
Cialis is currently available only by prescription for treatment of men with erectile dysfunction. Sanofi acquires exclusive rights to market Cialis OTC if regulatory approval is received.
Indianapolis Business Journal Healthcare reporter J.K. Wall says there is precedent for a company to ask for regulatory approval of a similar drug, Pfizer sought the approval for Viagra a few years ago, but withdrew its application before approval was granted or denied.
Wall feels Lilly and Sanofi are facing an uphill battle to convince regulators from patients misusing the drug. Wall says makers of Claritin and other allergy drugs faced the same hurdles to get their drugs approved for over the counter sale, but they also were representing more commonly-used drugs.
Lilly is set to lose their patent on Cialis in 2017, so Wall says they would need to get OTC approval beforehand to maximize the brand name recognition.
Cialis posted $2.2 billion in sales for Lilly last year alone.
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