Lilly hoping to turn Cialis into over-the-counter drug

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INDIANAPOLIS (May 28, 2014) – A French drug company is working with Eli Lilly to sell its erectile dysfunction drug Cialis as an over-the-counter medicine.

Sanofi announced plans to seek approval to sell Cialis without a prescription in the United States, Europe, Canada and Austrailia. It would market the drug after certain patents expire. Sanofi also holds exclusive rights to market Cialis OTC after all necessary regulatory hurdles are cleared. Terms of the licensing agreement were not disclosed.

According to our newsgathering partners at the Indianapolis Business Journal, Cialis generated $2.16 billion in sales last year. Beginning in 2017, it will face competition from generic drugs.

The deal gives Sanofi the chance to “transform how this important medicine is offered to millions of men throughout the world,” according to Vincent Warnery, senior vice president, Global Consumer Healthcare Division, Sanofi.

“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,” said David Ricks, senior vice president, Lilly, and president, Lilly Bio-Medicines.

Ricks said switching a medicine to over-the-counter is a highly regulated, scientifically rigorous process.

Cialis was first approved by the European Medicines Agency in 2002. A year later, the U.S. Food and Drug Administration granted its approval. The ED drug has been in use in more than 120 countries for ED and symptoms of benign prostatic hyperplasia (BPH). Lilly estimated that more than 45 million men have been treated with Cialis worldwide.

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