Maker of erectile dysfunction drug Cialis pushes for over-the-counter sales approval

Planning ahead for its patent expiration, Indiana-based Eli Lilly and Co. and French drugmaker Sanofi are partnering to seek approval for non-prescription sales of Cialis for treating erectile dysfunction.

by John Tyburski

Copyright © Daily Digest News, KPR Media, LLC. All rights reserved.

First published at Daily Digest News on May 28, 2014

Men who do not want to speak with their doctor about erectile dysfunction (ED) may eventually have access to Cialis without needing a prescription. On Wednesday, Eli Lilly and Co. announced a plan to partner with Sanofi, a French pharmaceutical company, in order to pursue regulatory approval for over-the-counter Cialis sales. Under the agreement and pending approval, Lilly will make the drug, and Sanofi will commercialize it in the U.S., Europe, Canada, and Australia in 2018, the year that the patents giving Lilly exclusive rights to Cialis sales will expire.

There are currently no over-the-counter medications approved by the U.S. Food and Drug Administration (FDA) for the treatment of ED. Pfizer pursued approval to sell Viagra, the first ED drug introduced in the late 1990s, without a prescription in 2008 in Europe but withdrew the application before it was approved.

Cialis was first approved in 2002 in Europe and then gained approval in the U.S. the following year. In 2018, the opportunity for anyone to make generic Cialis opens and is expected to cut deep into Lilly’s revenue. Cialis was Lilly’s fourth best-selling drug in 2013 and generated $2.16 billion in sales worldwide. The financial details of the deal struck with Sanofi were not revealed.

It is not clear whether the FDA has any inclination to consider the approval request. Even though Cialis seems to be relatively safe and has been prescribed to over 45 million men, over-the-counter use presents some hazards. One concern is that Cialis must not be taken with nitrates prescribed for chest pain, as a sudden drop in blood pressure may result. Another concern is that ED at times can be a symptom or consequence of another health issue that may go undetected in men buying Cialis without prescription and consultation with a doctor.

Otherwise, Cialis has a good track record and may reach anticipated vast numbers of ED sufferers who will not discuss the issue with their doctors.