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Last updated October 10, 2019. 2 minute read

Will Cialis be available over the counter?

In May 2014, Sanofi, the French pharmaceutical company, acquired the exclusive rights to apply for the right to market Cialis (tadalafil) over-the-counter (OTC) from drug company Eli Lilly.

Written by Health Guide
Reviewed by Dr. Jefferson Chen, MD

Cialis (tadalafil) is one of the most popular prescription medications for the treatment of erectile dysfunction (ED). In May 2014, Sanofi, the French pharmaceutical company, acquired the exclusive rights to apply for the right to market Cialis (tadalafil) over-the-counter (OTC) from drug company Eli Lilly. When off-patent, Sanofi has the right to make all applications for over-the-counter (OTC) approval in the United States, Australia, Canada, and Europe. This sparked a lot of interest in whether or not Cialis would soon be available without a prescription.

  • Cialis (tadalafil) is one of the most popular prescription medications for the treatment of erectile dysfunction (ED).
  • In May 2014, Sanofi, the French pharmaceutical company, acquired the exclusive rights to apply for the right to market Cialis (tadalafil) over-the-counter (OTC) from drug company Eli Lilly.
  • It is possible that Sanofi will explore the potential for Cialis to go over-the-counter.

Vitals

To be blunt, the hurdles to make Cialis available over-the-counter would be enormous in the United States. In Europe, a similar case proved to be a difficult challenge for Pfizer back in 2008 when they sought to gain approval for 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 erectile dysfunction would go untreated, left the company no choice but to withdraw its request. In 2017, however, Pfizer won approval in the UK to sell Viagra OTC, with the caveat that men would need to speak with a pharmacist first.

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At the moment, no plans exist for Viagra or Cialis to go OTC in the US, but the Sanofi deal with Eli 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 slip away. There is an appreciation for the need for education and the benefit of coaxing men into their healthcare provider’s office for evaluation.