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Can Generic Viagra Beat the Real Thing?

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Generic Viagra
Canada, the EU, and Asian countries have long had access to generic Viagra.
Generic versions of Viagra have been available outside the United States for several years.

Patent law is different in different countries, and Pfizer’s patent for Viagra won’t officially expire in the US until the year 2020. But in other countries, Pfizer’s Viagra patent expired long ago, and in some countries (like India) it was never applicable to begin with. So the world has extensive experience with sildenafil citrate, the active ingredient in Viagra.

American men have waited patiently for generic options to arrive here, and at one time it looked as if that wait could last until 2020. However, December 2017 should bring not one, but two generic competitors to Viagra to the US.

Why Pfizer Is Allowing Generic Competition Before Patent Expiration

Why would Pfizer, creator of Viagra, allow generic competition in the US before its patent for the brand name drug runs out? There are a couple of possible reasons. Pfizer is making efforts to solidify Viagra’s household name status by selling the drug directly online, offering men convenience and some discounts over buying at their local pharmacies.

But more importantly, by allowing generics to launch in the US more than two years before Viagra’s US patent runs out, Pfizer is able to dictate many of the terms generic manufacturers must adhere to in order to compete with name brand Viagra. These early generic competitors will have to pay royalties to Pfizer, at least at first. The result will probably be a more gradual decrease in Viagra prices in the US, compared to the nosedive that Viagra prices took in the EU a few years ago when Pfizer’s patents ran out in several countries there.

Teva, Mylan Getting Ready for a US Launch

Teva entered into an agreement with Pfizer a couple of years ago that allows them to start selling generic Viagra in December 2017. Under the terms of the agreement, Teva has to pay royalties to Pfizer (the specifics of which haven’t been disclosed) until the Pfizer patent expires. What that means for consumers is the introduction of a generic competitor may soften prices enough to be noticeable, but perhaps not enough to mirror the plummet prices took in the UK and EU countries a few years ago.

Pharmaceutical company Mylan also reached a patent litigation settlement with Pfizer in relation to Viagra, which will allow Mylan to launch their own generic sildenafil citrate in December 2017 (or possibly sooner, depending on certain unspecified conditions). Mylan isn’t talking about what was in the terms of the settlement and license agreement, but the company already does brisk business in Europe, where its generics are sold in 11 countries.

2012: Canada Allows Generic Competitors for Viagra

In November 2012, the Supreme Court of Canada opened up the Canadian market to generic competitors to Viagra, with the court invalidating Pfizer’s patent in Canada. It was a unanimous ruling stating that Pfizer was trying to “game” the Canadian pharmaceutical system by stringing out its patent beyond what was reasonable.

On the other side of that court battle was Teva Canada, which was ready with generics as soon as it won its appeal to Canada’s Supreme Court. Almost immediately after the court ruling, Teva Canada’s website introduced Novo-Sildenafil, its generic alternative to Viagra. Teva alleged that Pfizer did not meet disclosure terms concerning pharmaceuticals under Canadian law, and the high court agreed. Teva’s legal victory was seen as a win for Canadian consumers, who otherwise would have had to wait until 2014 for patent relief and generic competition to Viagra.

Other Countries’ Experiences with Generic Viagra

In June 2013, patents on Viagra expired in a number of European countries, and at that time generic makers were ready to go to market, many of them having received preapproval so they could start selling as soon as the patent expired. Mylan and Teva, the companies that will be first to release generic Viagra in the US, were among the first to sell generics in the EU, along with a third company, Actavis.

In many countries, more than one generic became available basically overnight, and the result was a precipitous drop in prices. In the UK, for example, where three new generics went on the market as soon as Pfizer’s patent expired there, prices dropped by 90% and Pfizer was forced to cut its price for the name brand drug in an attempt to hold onto market share. Interestingly, one of Pfizer’s generic competitors in the EU has been … Pfizer. One of its facilities in Amboise, France, started making a generic version of Viagra, but since Pfizer and Allergan merged last December, the new pharmaceutical giant is considering selling off its generics programs altogether.

Differences Between Generic and Name Brand Drugs

According to the Food and Drug Administration (FDA), generic drug products must meet rigorous standards concerning identity, strength, purity, potency, and quality before gaining approval. The FDA acknowledges that variability occurs during manufacturing, though this holds true both for generics and for name brand drugs.

Generics are required to contain the same active ingredient, strength, dosage form, and means of administration as the name brand product, and they must prove bioequivalence to the name brand product. What that means is, when someone takes a generic and later has the drug levels measured in his or her blood, the same levels should be evident as would be measured with the name brand product.

Furthermore, generic packaging, manufacturing, and testing have to pass all the quality standards as non-generic manufacturers do. In some cases, the generic drugs are made in the exact same manufacturing plants as the name brand drugs.

Generic Viagra
The FDA holds generics to standards equal to those of brand name drugs.
How Does Pfizer Cope with Generic Competition?

Pfizer is doing fine despite the patent on blockbuster drug Lipitor expiring a few years ago and the patent on Viagra in several countries having expired. The company exceeded Wall Street expectations in the fourth quarter of 2015, partly due to rising sales of its newer drugs, and partly due to medicines made by companies Pfizer has acquired. While holding onto patent protection for another year and a half in the US will help keep Pfizer’s earnings up, the company is counting on new, innovative drugs, including cancer medications and vaccines to help them meet or exceed financial expectations and soften the blow of Viagra’s patent expiration.

Trying to Obtain Generic Viagra in the US Is Currently Risky

The bottom line for men in the US is that trying to obtain generic alternatives to Viagra is still risky. Imports of prescription medications are only allowed under strict conditions (which aren’t met by generic Viagra), and orders from foreign “pharmacies” can be held by US Customs and Border Patrol if they’re discovered. The huge problem of fake pharmaceuticals is another reason American men are best off waiting until the end of 2017 to buy generics, when they can know that what they’re buying is FDA approved.

At eDrugstore.com, we have served over half a million satisfied customers since 1998, working with US-licensed pharmacists to dispense name brand Viagra, Cialis, Levitra, and other lifestyle drugs. With fast, discreet shipping and competitive prices, our goal is to provide the best customer experience with every order. We invite you to browse our extensive information on erectile dysfunction and its treatment.

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