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Can You Buy Cialis Over The Counter In The Usa

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A Plan to Sell Cialis, an Erectile Drug, Over the Counter

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. 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.D.,” or erectile dysfunction, said David A. Ricks, president of Lilly Bio-Medicines, the unit of Lilly that oversees Cialis. “We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from E.D. 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.

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A 2009 Cialis ad. The maker of Cialis, Eli Lilly, and the French firm Sanofi are in a deal to sell the drug without a prescription.

A spokeswoman for the F.D.A. 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.

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. In 2003, AstraZeneca 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.

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Sales of erectile dysfunction drugs have soared since Viagra was approved in 1998, but the companies that sell them have also struggled against the social stigma of male impotence. Many men, unwilling to visit a doctor for a prescription — or seeking lower prices — have turned to online marketplaces, many of which sell the drugs illegally. Last year, in an effort to recoup some of those lost sales, Pfizer began selling Viagra to consumers through its own website.

The move to make Cialis available without a prescription could be seen in a similar vein, as removing one of the hurdles — a visit to the doctor — to getting treatment.

But one urologist, Dr. Kevin L. Billups of the Johns Hopkins School of Medicine, expressed concern about moving Cialis to an over-the-counter product because, he said, erectile dysfunction can be an early warning sign for more serious conditions like diabetes and heart disease.

“Maybe you’re missing an opportunity to pick up something else,” said Dr. Billups, who is director of the school’s Men’s Health and Vitality Program.

Cialis, which was approved in the United States in 2003, brought in $2.2 billion in worldwide sales last year. Viagra, which recently lost its patent protection in several countries, brought in $1.9 billion.

A version of this article appears in print on May 29, 2014, on page B5 of the New York edition with the headline: Plan to Sell an Erectile Drug Over the Counter. Order Reprints | Today’s Paper | Subscribe

Cialis: Fast-Acting Treatment of Erectile Dysfunction

Men who have ever had a problem of erectile dysfunction are familiar with medications that stimulate erection. Nearly every one knows that drugs of this group mechanically cause sustained erection. Indeed, stimulants are composed of complex chemical substances which create a relaxing effect on the smooth muscles of the cavernous bodies of the penis, thus stimulating active blood supply.

Viagra is the first and one of the most popular erection stimulating drug on the market. Its main chemically synthesized active component is 1-[4-ethoxy-3-(6,7-dihydro-1-methyl-
7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)phenylsulfonyl]-4-methylpiperazine. Initially this chemical compound was developed by scientists to improve blood flow to the myocardium (heart muscle) in order to help decrease blood pressure. However, clinical trails haven’t shown the expected results but it was found that men taking this drug experienced substantial blood flow to the genitals. Several years later this medication entered the market under the brand name Viagra. It was positioned as the drug aimed to fix problems with poor erection. As far as it was the only medication for ED at that time, it got the reputation of the fastest-selling drug generating nearly $2 billion from sales worldwide.

But now there is a number of analogical medications on offer and Cialis is one of them. It contains the same active ingredient (sildenafil), which creates absolutely identical effect as Viagra. Cialis should be taken about an hour before having sex and not more than once a day. Remember that Cialis as well as other erection stimulating drugs do not increase libido, so proper sexual stimulation is required to get the maximum pleasure. But there is one distinctive feature of Cialis that makes it stand out among other ED pills – it can be taken on a daily basis in smaller doses. Unlike Viagra or any other drugs Cialis can be prescribed for a daily use for ED treatment depending on the severity of the disease. So there is a choice for a man: either to use Cialis once right before intercourse or to take it daily.

Since Cialis is being sold for many years already, there are lots of reviews of men whose sexual health has been restored due to these pills. One can easily find them online on men’s forums where they share their experience of taking Cialis. You can also order the medication via online pharmacies without a need to leave your house. The best thing of buying Cialis online is that you can do it without prescription, though it’s always recommended to visit your doctor before starting to take any medication.

FAQ

Drug maker wants to sell Cialis over the counter

INDIANAPOLIS — The maker of erectile dysfunction drug Cialis wants its pill sold to men without a prescription.

Under a licensing deal between Eli Lilly and Co. (LLY) and French drugmaker Sanofi (SAN), Cialis could become the first prescription drug for male impotence to be sold over the counter. The plan still needs approval from regulators, who would weigh the risks of allowing the drug to be sold without a doctor’s visit.

The two companies hope for a 2018 launch of what they’re calling Cialis OTC. That’s the same year patents for Cialis are expected to expire in the United States and Europe, allowing cheaper generics to take over and effectively dry up Lilly’s considerable profits from the drug.

Cialis generated $2.16 billion in sales last year and was Lilly’s fourth best-selling drug.

A plan to sell Cialis over the counter would allow the Indianapolis drugmaker to continue to profit from the drug as an impotence treatment.

Lilly didn’t reveal financial details of the deal with Sanofi. Under the deal, Sanofi will be responsible for commercializing nonprescription Cialis wherever it receives approval while Lilly will manufacture Cialis for Sanofi. The drug, sold in tablet form, is made by Lilly in Puerto Rico.

“Men don't want to go through the hassle and sometimes discussions with doctors. There is a need to self-diagnose.”

-&nbspDave Ricks, Eli Lilly and Co.

Cialis has been prescribed to more than 45 million men since its launch in Europe in 2002 and in the United States a year later. The drug has been widely used and proven to be safe and effective, so it’s a good candidate to sell over the counter, said Dave Ricks, a senior vice president at Lilly.

In addition, over-the-counter sales would be a safer option for men than buying illicit forms of Cialis online without a prescription, Ricks said. He said many of the Cialis tablets advertised online are fake or adulterated.

A large unmet demand exists for over-the-counter Cialis because many men suffering from impotence don’t feel comfortable talking to a doctor about the problem, Ricks said.

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«Half of (American) men over 40 suffer ED,» Ricks said. «But the current market (for prescription ED drugs) only represents a fraction (of potential patients). Men don’t want to go through the hassle and sometimes discussions with doctors. There is a need to self-diagnose. We think that (over-the-counter) availability is key to helping guys» with impotence.

The first prescription erectile dysfunction drug to market was Pfizer’s Viagra, introduced in the late 1990s. Pfizer applied in Europe several years ago to sell Viagra over the counter but later withdrew its request.

Eli Lilly’s Cialis orange tablet was the second erectile dysfunction the FDA approved.

Eli Lilly’s Cialis orange tablet was the second erectile dysfunction the FDA approved.

Eli Lilly and Co.

Lilly said Sanofi will take the lead in pursuing regulatory approval to sell Cialis over the counter. One concern for regulators will be that Cialis isn’t supposed to be taken with medicines called nitrates often prescribed for chest pain. The combination can cause a dangerous drop in blood pressure.

Regulators also might be concerned that impotence is sometimes a sign of other medical problems, which won’t be discovered if men are allowed to buy Cialis without a checkup.

Potentially, regulators could approve over-the-counter sales of Cialis only at certain doses and for some indications, Ricks said.

Lilly said it struck a deal with Sanofi to take the lead in Cialis OTC because Sanofi has experience in conducting consumer studies and gaining approval for over-the-counter formulations of other brand drugs, including allergy medications Nasacort and Allegra.

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