{"id":17557,"date":"2017-04-21T08:00:06","date_gmt":"2017-04-21T15:00:06","guid":{"rendered":"https:\/\/www.accessrx.com\/blog\/?p=17557"},"modified":"2025-05-26T19:06:50","modified_gmt":"2025-05-26T12:06:50","slug":"over-the-counter-viagra-is-it-coming-soon","status":"publish","type":"post","link":"https:\/\/www.edrugstore.com\/blog\/erectile-dysfunction\/viagra\/over-the-counter-viagra-is-it-coming-soon\/","title":{"rendered":"Over-the-Counter Viagra: Is It Coming Soon?"},"content":{"rendered":"
\"Viagra\"<\/a>
Over-the-counter Viagra could soon become available in the United Kingdom.<\/figcaption><\/figure>\n

British regulatory agencies are considering a proposal to allow over-the-counter sales of Viagra, Pfizer\u2019s little blue pill that forever changed the treatment of erectile dysfunction. Should the proposal get the green light, the approval would extend only to sales within Great Britain. However, such a move almost certainly would create pressure for a similar marketing strategy in the United States.<\/p>\n

First introduced in 1998, Viagra is designed to treat erectile dysfunction caused by insufficient blood flow to the penis, the most common cause of ED. Although ED can occur in men of all ages, it is a significant obstacle to sexual fulfillment among the elderly<\/strong>.<\/p>\n

Tried Earlier in European Union<\/strong><\/h2>\n

This is not Pfizer\u2019s first attempt to win approval for OTC sales of Viagra in Europe. In late 2008, the U.S.-based pharmaceuticals giant withdrew a similar proposal from consideration by the European Medicines Agency<\/a>, which holds the ultimate responsibility for approving and regulating the medications sold within the European Union.<\/p>\n

Under that earlier proposal, filed in mid-2008, Pfizer sought permission to have Viagra reclassified from a \u201cmedicinal product subject to medical prescription\u201d to a \u201cmedicinal product not subject to medical prescription.\u201d Had that proposal won EMA approval, Pfizer would have been allowed to market 50-milligram tablets of Viagra over the counter in most countries of the European Union, including the United Kingdom.<\/p>\n

Pfizer Files Bid with UK Agency<\/strong><\/h2>\n

In view of U.K. voters\u2019 decision to withdraw from the European Union — the so-called Brexit vote — the approval and regulation of medications within the U.K. will now be the province of Britain\u2019s Medicine and Healthcare Products Regulatory Agency, or MHRA. It is to this latter agency that Pfizer Consumer Healthcare brought its latest OTC proposal in early 2017.<\/p>\n

Pfizer\u2019s decision to withdraw its 2008 petition for OTC Viagra approval came after the EMA\u2019s Committee for Medicinal Products for Human Use indicated that it had further concerns about the advisability of selling Viagra over the counter. Because of these concerns and in the absence of further input from Pfizer, the EMA committee had provisionally decided Viagra was a poor fit for OTC sales.<\/p>\n

Concerns about OTC Viagra<\/strong><\/h2>\n

Among the concerns cited by EMA\u2019s Committee for Medicinal Products for Human Use was the fear that the ready availability of Viagra might tempt some men with ED to try the drug without having the underlying health problems responsible for ED diagnosed by their doctors. The committee also expressed its concern that the drug\u2019s accompanying information was too complex and thus might lead some ED patients to use the drug incorrectly. Yet another concern was the possibility that the drug could be used outside its approved indication, such as for recreational purposes.<\/p>\n

\"Viagra\"
Tadalafil is the active ingredient in Cialis, another ED drug that could become available over the counter in the foreseeable future.<\/figcaption><\/figure>\n

In its most recent application seeking OTC approval in the U.K., Pfizer sought to address some of the earlier concerns expressed during its campaign to take Viagra over the counter throughout the European Union. In a press release<\/a> issued at the time of its U.K. petition, Pfizer said that it was \u201ccommitted to patient safety, and to ensuring that non-prescription sildenafil is supplied in a way that supports patient safety and improves patient health. Pharmacists are well placed to provide men with helpful and appropriate guidance to manage their erectile dysfunction, and should refer men to a doctor if they believe further investigation is required.\u201d<\/p>\n

Pills Would Retain Iconic Look<\/strong><\/h2>\n

Under its proposal to market Viagra over the counter in the United Kingdom, Pfizer indicated that the drug would be described in all product materials simply as sildenafil citrate, which is the active ingredient in Viagra. However, the pills themselves would retain the iconic blue diamond shape and carry the Pfizer imprint.<\/p>\n

Interestingly, Pfizer\u2019s push for OTC sales of Viagra on the other side of the Atlantic comes at a time when the American market is preparing for the December 2017 debut of a generic formulation of the little blue pill. That generic medication will be rolled out by Teva Pharmaceuticals under a licensing agreement Teva struck with Pfizer in late 2013. Under that court-supervised agreement, Teva will be required to pay Pfizer a licensing fee until Pfizer\u2019s U.S. patent on Viagra expires in April 2020.<\/p>\n

Bid to Market Cialis OTC<\/strong><\/h2>\n

Also still in the works is a joint proposal from Eli Lilly & Company and Sanofi to market an OTC version of Lilly\u2019s popular ED drug Cialis. Lilly, based in Indianapolis, and Sanofi, a multinational pharmaceuticals company based in Paris, first proposed the Cialis OTC venture in May 2014. The companies expressed the hope that they could win approval to market the ED drug in the United States, as well as Australia, Canada, and Europe.<\/p>\n

As this is written, neither Lilly nor Sanofi could confirm the current status of the Cialis OTC proposal or whether it has been approved in any of the target markets. Even if the Cialis OTC proposal never comes to fruition, Americans can expect a generic version of Cialis within the next year or so as Lilly\u2019s U.S. patent on the drug is soon scheduled to expire.<\/p>\n

As of this writing, none of the popular ED medications is available in the United States in generic form or over the counter, although that will change in the months to come. In the meantime, you\u2019ll need a prescription to purchase any ED drug. If the convenience of online ordering appeals to you, you might want to consider placing your order through eDrugstore.com, a reliable supplier of FDA-approved medications, all of which are sourced from licensed U.S. pharmacies. To get started, visit eDrugstore\u2019s Erectile Dysfunction page<\/a>.<\/p>\n

 <\/p>\n

<\/p>\n

\"\"<\/p>\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

British regulatory agencies are considering a proposal to allow over-the-counter sales of Viagra, Pfizer\u2019s little blue pill that forever changed the treatment of erectile dysfunction. Should the proposal get the green light, the approval would extend only to sales within Great Britain. However, such a move almost certainly would create pressure for a similar marketing […]<\/p>\n","protected":false},"author":1,"featured_media":17558,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_autoblog_aioseo_focus_keyphrase":"","_autoblog_aioseo_title":"","_autoblog_aioseo_description":"","footnotes":""},"categories":[17],"tags":[184],"class_list":["post-17557","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-viagra","tag-viagra"],"acf":[],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t