The hurdles to gain over-the-counter (OTC) status for Viagra
would be enormous in the United States. Even in Europe, it proved to be a difficult challenge for Pfizer back in 2008 when they sought to gain approval for over-the-counter (OTC) sales of Viagra. Concerns about the potential for misuse, the complicated educational material needed to accompany the medication, and the fact that the underlying medical conditions leading to ED would go untreated, left the company no choice but to withdraw its request.
However, in May 2014, Sanofi, the French pharmaceutical company, acquired the exclusive rights to apply for the rights to market Cialis OTC from drug company Lilly. When off patent, Sanofi has the right to make all applications for OTC approval in the United States, Australia, Canada, and Europe.
At the moment no plans exist for Viagra to go OTC but the Sanofi deal with Lilly remains and, with Cialis beginning to lose its multiple patent protections, it is possible that Sanofi will explore the potential for Cialis to go over-the-counter.
Nevertheless, the concerns have only increased about allowing underlying conditions to remain untreated, and for an opportunity to educate men about the need to utilize the healthcare system to go unmet. There is an appreciation for the need for education and the benefit of coaxing men into their doctor’s office for evaluation.
For the foreseeable future, it is hard to imagine any of the erectile dysfunction drugs becoming available over-the-counter.