Sanofi and Lilly announce licensing agreement for Cialis OTC

French drug major Sanofi (Euronext: SAN) and US drug major Eli Lilly (NYSE: LLY) have agreed to pursue regulatory approval of non-prescription Cialis (tadalafil), currently available by prescription worldwide for the treatment of men with erectile dysfunction (ED).

Under the terms of the agreement, Sanofi acquires the exclusive rights to apply for approval of Cialis OTC in the USA, 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.

Vincent Warnery, senior vice president, Global Consumer Healthcare Division, Sanofi, said: “This agreement provides us with an opportunity to work with Lilly, a leader in men's health, to transform how this important medicine is offered to millions of men throughout the world. The opportunity to forge an industry-leading partnership that adds to Sanofi Consumer Healthcare's leading portfolio and successful track record of over-the-counter switches reinforces consumer health care as a major growth platform for Sanofi.”