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Viagra Can Be Purchased Over the Counter in UK. Is Australia Next?

Erectile dysfunction

In recent years, several drugs previously available only by prescription have been approved for over-the-counter sale, both in the United States and other countries as well.

By early 2018, British men with erection problems will be able to purchase Viagra over the counter in pharmacies throughout the United Kingdom. Closing in on its 20th anniversary, the little blue pill that offered a revolutionary new way to treat erectile dysfunction won approval for OTC sales in a decision handed down in late November 2017 by the U.K.’s Medicines and Healthcare Products Regulatory Agency.

The British regulatory agency’s decision will make the popular ED drug more readily available to men who need it, who will no longer have to visit a doctor to get a prescription for the medication. Also, importantly, it will hopefully cut down on the bustling black market business for so-called Viagra, which is more often than not counterfeit and potentially harmful to those who use it.

Viagra Sales Soar in UK

The popularity of Viagra and the other ED medications that have followed in its wake has grown sharply in the United Kingdom, according to data from the country’s Health and Social Care Information Centre, also known as NHS Digital. Based on a report published on TheGuardian.com, prescriptions for sildenafil citrate, the active ingredient in Viagra and its generic alternatives, climbed from 1,042,431 in 2006 to 2,958,199 in 2016.

The sharp upsurge in demand for Viagra and generic substitutes reflects not only a gradual decrease in prices — Pfizer’s U.K. patent on the drug expired in mid-2013 — but also a marked decline in the stigma attached to erectile dysfunction and thus the drugs that treat it.

However, in that same report posted at TheGuardian.com, Britain’s Royal College of General Practitioners warned about the dangers of buying Viagra and other ED drugs online from vendors of questionable repute. All too often the drugs obtained in this fashion are fakes that use toxic ingredients as coloring agents and filler material. Scientific examination of some so-called Viagra, available without prescription online or through other black market sources, have found that such drugs sometimes do contain Viagra’s active ingredient, but at amounts so low as to be ineffective or so high as to be hazardous to one’s health.

Should Reduce Black Market Sales

Both the physician group and regulatory agency have expressed the hope that the easy availability of the real thing will cut down significantly on black market sales of the drug.

In the wake of MHRA approval, Pfizer  hopes to get Viagra Connect, the drug’s OTC version, on pharmacy shelves by the spring of 2018.

Viagra

Sildenafil citrate is the active ingredient in Viagra and all generic substitutes for the little blue pill.

Unless another country moves quickly to approve OTC sales of Viagra or another ED drug, the United Kingdom will soon become the only country where ED medications are available over the counter. Almost a decade ago, Pfizer tried to win approval to sell Viagra over the counter throughout the countries of the European Union. However, it was forced to withdraw that request after the European Medicines Agency expressed concerns about the safety implications of such sales.

OTC Viagra May Spread Elsewhere

While it seems certain that the United Kingdom will be the first country to allow OTC sales of an ED drug, there have been other attempts to win approval for OTC marketing of impotence medications. Eli Lilly and Company, which holds the patent on Cialis, struck a tentative agreement in 2014 with French drugmaker Sanofi under which the latter would be licensed to sell Cialis over the counter in the United States beginning in 2018. The agreement was tentative pending U.S. government approval of such a marketing scheme. However, although the 2014 agreement made headlines at the time, little has been heard about it in the years since. It’s unclear whether the agreement was scrapped or if the U.S. government indicated it would not be receptive to such a proposal.

Only days after Pfizer won U.K. regulatory approval to sell Viagra over the counter, Nial J. Wheate, a pharmaceutical chemist at Australia’s University of Sydney, told Australia’s ABC News that Australia should follow in Britain’s footsteps. He said such a move might help to discourage the trafficking in counterfeit drugs that are being passed off as Viagra or other ED medications.

Dangers of Illegitimate Internet Pharmacies

Wheate pointed specifically to the dangers posed by illegitimate internet pharmacies to which many impotent men turn if they can’t — or don’t want to — get the drugs through normal channels. “Being able to make it [generic Viagra] available in Australia through pharmacies will help to mitigate that risk,” he added. Wheate said a recent study estimated the number of illegitimate online pharmacies at roughly 1,800.

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While Viagra will become available over the counter in the United Kingdom in a matter of a few months, changes of a somewhat different kind are coming to the Viagra market in the United States. Under agreements that Pfizer reached with generic drugmakers Teva Pharmaceuticals and Mylan N.V. in late 2013, those companies won the right to begin selling generic versions of Viagra in late 2017 or early 2018.

Pfizer’s Viagra Patent Valid Till 2020

Under those agreements, Viagra retains its U.S. patent on Viagra until April 2020, meaning that Teva and Mylan will be required to pay Pfizer royalties for the privilege of marketing generic alternatives to the little blue pill. Pfizer itself will market a generic version of the popular ED drug, which will be manufactured by Greenstone LLC, a subsidiary of Pfizer that specializes in manufacturing and marketing generic drugs.

These three generic formulations of Viagra will go head to head with Pfizer’s brand-name Viagra, which Pfizer hopes will retain customers who prefer using brand-name drugs and don’t mind spending a bit more for them. Although this quite obviously will shake up the Viagra market in the United States, it very likely will have repercussions in the American sales of other ED drugs.

Lower Prices Often Trump Brand Loyalty 

Customers who have been hard pressed to pay the relatively hefty prices charged for other brand-name ED drugs will be tempted to try the lower-priced generic alternatives to Viagra, even though that might not have been the original ED drug of their choice. The downward price pressure created by generic competition is also likely to increase the customer base for ED drugs as men who previously could not afford the brand-name drugs are drawn into the market by lower prices.

Under the Food and Drug Administration’s regulations governing generic drugs, these alternatives to brand-name drugs must contain the same active ingredient, have the same strength, same dosage form, and same route of administration. Generics, however, may bear no resemblance to the brand-name for which they are substitutes. Although FDA rules require that generics contain the same active ingredient, the generic’s inactive ingredients — usually used as fillers and coloring agents — need not be the same as those in the brand-name drug.

Viagra Was First of PDE5 Inhibitors

Introduced in 1998, Viagra was the first of the erectile dysfunction drugs known as PDE5 inhibitors, a type of drug designed to treat ED caused by insufficient blood flow to the penis, the number one cause of male impotence. During the clinical trials conducted in support of Pfizer’s New Drug Application for Viagra, the medication was shown to be effective and safe in the vast majority of men among whom it was tested.

However, neither Viagra nor any of the other PDE5 inhibitors — Levitra, Cialis, Staxyn, or Stendra — should be taken by men who are regularly using nitrate-based drugs, such as those prescribed to treat angina and intractable hypertension. All of these drugs tend to lower blood pressure significantly and could cause a life-threatening drop in blood pressure if taken together.

Prescription Still Required in US

Erectile dysfunction

The availability of Viagra over the counter is likely to expand its market base in the United Kingdom.

As you’ve seen, Viagra will soon be sold over the counter in the United Kingdom, making it available to customers without a prescription. However as U.S. regulations now stand, a prescription is required to purchase Viagra or any other PDE5 inhibitors in this country. Your regular doctor or a urologist can supply you with a prescription, which can then be used to buy the drug at a local pharmacy or to order it online from a trustworthy supplier on the Internet. One such supplier, in business since 1998, is AccessRx.com.

If you already have a doctor’s prescription, you can fax it or scan and email it along with your order to AccessRx. Alternatively, you can avail yourself of a complimentary online consultation with one of AccessRx’s team of licensed U.S. physicians. To facilitate such a consultation, you will have to fill out a questionnaire that details your ED symptoms, as well as your medical history, and lists any medications you are taking. If you are deemed an appropriate candidate for Viagra or other PDE5 inhibitor, AccessRx’s doctor will authorize a prescription. To get started, click below to reach the website’s Erectile Dysfunction page.

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About Don Amerman

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Don Amerman has spent more than three decades in the business of writing and editing. During the last 15 years, his focus has been on freelance writing. For almost all of his writing, He has done all of his own research, both online and off, including telephone and face-to-face interviews where possible. Don Amerman on Google+