PARIS Sanofi and Eli Lilly and Co have agreed to pursue regulatory approval for over-the-counter sales of erectile dysfunction treatment Cialis, the French and U.S. drugmakers said in a statement on Wednesday.
Cialis is currently available by prescription only, and was first approved by the European Medicines Agency in 2002 and then by the U.S. Food and Drug Administration in 2003. It generated $2.16 billion in worldwide sales in 2013 and has recorded total sales of more than $14 billion since launch.
Under the terms of the agreement, Sanofi is buying the exclusive rights to apply for approval of Cialis tablets over the counter in the United States, Europe, Canada and Australia. Terms of the licensing agreement were not disclosed.
(Reporting by James Regan; Editing by Mark Potter)