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    Men with erectile dysfunction may be able to avoid the awkwardness of a doctor’s visit by buying the drug Cialis without a prescription, under a proposal announced Wednesday by the drug’s maker, Eli Lilly, and the French pharmaceutical company Sanofi. Under the plan, Sanofi is buying the rights to seek approval to sell Cialis over the counter in the United States, Europe, Canada and Australia after certain patents expire. Cialis is to lose its patent protection in the United States and Europe in 2017, after which sales are expected to drop sharply as cheaper generic alternatives arrive on the market. If approved for over-the-counter use, Cialis could gain an advantage over prescription competitors like Viagra, sold by Pfizer. said the agency would need to review what types of studies would be needed for an erectile dysfunction drug like Cialis to be sold without a prescription. But it is not clear whether the Food and Drug Administration or other regulatory bodies overseas would approve such a move: In 2008, Pfizer abandoned an effort to make Viagra available without a prescription after the European Medicines Agency raised concerns.“Millions of men worldwide trust Cialis to treat E. Ricks, president of Lilly Bio-Medicines, the unit of Lilly that oversees Cialis. Drug companies frequently seek approval to move popular drugs to over-the-counter sales in an effort to hang onto sales when a best-selling product loses its patent protection. “We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from E. to obtain convenient access to a safe and reliable product without a prescription.”Although more than 45 million men have taken Cialis, according to Lilly, the drug is not without risks: Like similar treatments, it should not be taken with some heart medications because it could cause an unsafe drop in blood pressure. In 2003, Astra Zeneca got approval to sell its blockbuster heartburn drug Prilosec without a prescription, and in 2012, it sold over-the-counter rights to a similar drug, Nexium, to Pfizer. The nonprescription product, Nexium 24HR, went on sale this week. Tadalafil, sold under the brand name Cialis among others, is a medication used to treat erectile dysfunction (ED), benign prostatic hyperplasia (BPH), and pulmonary arterial hypertension. For ED it is recommended as an 'as needed' medication. Tadalfil was approved for medical use in the United States in 2003. It initially was developed by the biotechnology company ICOS, and then again developed and marketed worldwide by Lilly ICOS, LLC, the joint venture of ICOS Corporation and Eli Lilly and Company. Tadalafil was approved in 2009 in the United States for the treatment of pulmonary arterial hypertension and is under regulatory review in other regions for this condition. In late November 2008, Eli Lilly sold the exclusive rights to commercialize tadalafil for pulmonary arterial hypertension in the United States to United Therapeutics for an upfront payment of $150 million. In 2016 it was the 280th most prescribed medication in the United States with more than a million prescriptions. Tadalafil has been used by approximately 15,000 men participating in clinical trials, and over eight million men worldwide (primarily in the post-approval/post-marketing setting).

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