Sanofi and Eli Lilly and Company have formed an agreement to pursue regulatory approval of nonprescription Cialis (tadalafil). Cialis is currently available by prescription only worldwide for the treatment of men with erectile dysfunction.

Under the agreement, Sanofi acquires the exclusive rights to apply for approval of Cialis OTC in the United States, Europe, Canada, and Australia. Sanofi also holds exclusive rights to market Cialis OTC following Sanofi’s receipt of all necessary regulatory approvals. If approved, Sanofi anticipates providing Cialis OTC after expiration of certain patents. Terms of the licensing agreement were not disclosed.

Cialis was first approved by the European Medicines Agency in 2002, and by FDA in 2003, for the treatment of erectile dysfunction. Ultimately, Cialis has received approval in more than 120 countries for indications that vary by country, including erectile dysfunction and erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia. Cialis had 2013 sale of $2.16 billion. In the US, the compound and use patents for prescription Cialis are in effect until 2017 and the compound patent in major European countries is in effect until 2017, according to Eli Lilly’s 2013 annual financial filing.  

In 2013, Sanofi Consumer Healthcare posted revenues of EUR 3.0 billion ($4.1 billion), representing a 5.2% growth compared to 2012 (constant exchange rates).

See related story, “Novartis, GSK, Bayer and Merck Become Movers in the OTC Market”

Source: Eli Lilly and Sanofi