Currently, Cialis is available worldwide by ‘prescription only’ for the treatment of men with erectile dysfunction (ED).
As part of the deal, Sanofi is acquiring the exclusive rights to seek approval of Cialis OTC in the US, Europe, Canada and Australia.
The French firm also holds exclusive rights to market Cialis OTC following its receipt of all necessary regulatory approvals.
Sanofi intends to market the erectile dysfunction drug after expiration of certain patents.
Sanofi senior vice president of Global Consumer Healthcare Division Vincent Warnery said the agreement provides the company 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," Warnery said.
Lilly senior vice president and Lilly Bio-Medicines president David Ricks said millions of men worldwide trust Cialis to treat ED.
"We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from ED to obtain convenient access to a safe and reliable product without a prescription," Ricks said.
"Switching a medicine to over-the-counter is a highly regulated process that is data-driven and scientifically rigorous.
"Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use over-the-counter Cialis appropriately."
In 2002, Cialis was first approved by the European Medicines Agency, followed by the US Food and Drug Administration in 2003, for the treatment of ED.
Image: Eli Lilly and Company’s global headquarters, in Indianapolis, Indiana, US. Photo: courtesy of Guanaco152003