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Generic Viagra: When Will it Be Available?

Generic Viagra should become available in the US in December 2017.

Generic Viagra should become available in the US in December 2017.

In December 2013, Pfizer settled a dispute with Teva Pharmaceuticals to allow the launch of a generic version of Viagra in the United States in 2017.

Although Pfizer claims to have patent protection for Viagra until April 2020, it has agreed that Teva may launch its generic version in December 2017. There’s a chance the drug could be released earlier due to unspecified “certain circumstances.” Pfizer’s basic patent on Viagra expired in 2012, but the company has been able to successfully defend itself against US challenges because it also has a “method of use” patent on Viagra, which specifically covers the drug’s ability to treat erectile dysfunction (ED).

While Pfizer is one of the biggest pharmaceutical companies in the world, so is Teva, so the case isn’t exactly David vs. Goliath. Teva is the largest generic manufacturer in the US, and is headquartered near Philadelphia. Teva Pharmaceuticals USA is a wholly-owned subsidiary of Teva Pharmaceutical Industries Ltd., which is based in Israel and is the global leader in generic drugs and one of the top 10 pharmaceutical companies in the world. Pfizer’s history with Teva goes back several years.

Pfizer and Teva’s History

In 2010, Teva sued Pfizer in US District Court in Norfolk, Virginia, claiming that Pfizer’s method of use patent wasn’t valid and could not be enforced. Teva’s goal was to be able to sell generic Viagra in the US as soon as Pfizer’s original patent expired in 2012. However, US District Judge Rebecca Beach Smith ruled in favor of Pfizer in August 2011, upholding the validity of the method of use patent.

The two companies clashed in Canada in 2013 in the case Teva Canada Ltd. v. Pfizer Canada Inc. At that time, the Supreme Court of Canada ruled that Teva established its allegation that Pfizer’s patent was not valid due to patent disclosure requirements in Canada. The court declared Pfizer’s “notice of prohibition” against Teva’s generic sildenafil dismissed. On June 4, 2013, the day of the ruling, Teva Canada launched its generic version of Viagra, Novo-Sildenafil, there.

Pfizer and Loss of Patent Protection in Europe in 2013

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Last year was also an important year for Pfizer in Europe, because the patent for Viagra in many European countries ended June 21, 2013. Soon thereafter, many generics entered the European market. Because of the influx of generics, prices in the UK alone fell from around £10 (US$16.60) per tablet to around £1 (US$1.66) per tablet.

But Pfizer isn’t just sitting back and watching its market share of the ED drug sector disappear. Viagra is still a big seller, bringing in more than $2 billion in revenue worldwide in 2013. Viagra is the company’s sixth best-selling drug. The company recently launched its own Viagra sales website featuring discount coupons in an attempt to give consumers a discreet method for purchasing the drug and to combat counterfeiters, who often target ED drugs, particularly Viagra. Third quarter sales in European markets in 2013 did, however, drop by more than 40% due to the generic options.

What Does the Teva Agreement Mean for US Consumers?

The settlement with Teva allowing it to start selling generic Viagra in 2017 means that US consumers will see a generic alternative a couple of years sooner than it would otherwise. Part of the terms of the agreement indicate that Teva will pay royalties to Pfizer for some period of time, so US consumers shouldn’t expect the bargain basement prices that Europeans have on generic Viagra. However, once Pfizer’s patent ends for good in 2020, the US market could see an influx similar to that seen in Europe in 2013.

European Viagra revenues fell in 2013, but Pfizer has new potential blockbuster drugs in the pipeline.

European Viagra revenues fell in 2013, but Pfizer has new potential blockbuster drugs in the pipeline.

What Does Teva Agreement Mean for Pfizer?

Pfizer is not suffering too extensively from the loss of patent protection in Europe, and its deal with Teva ensures a softer landing once patent protection ends in the US. Pfizer has numerous blockbuster drugs already on the market, and other promising ones in the pipeline. By the time Pfizer loses Viagra patent protection in the US, it is generally expected that the company will more than make up for the revenue losses with revenues from new drugs. Pfizer stock prices have hovered around $30 to $31 for the past six months, with only a brief dip to around $27.50 around the time generics came on the market in Europe.

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About Mary Hiers

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Mary Hiers is a full-time writer with a background in engineering and print journalism as well as writing about a wide variety of health care topics. She lives in Tennessee and is the author of two works of fiction. Mary earned her bachelor's and master's degrees from the University of Tennessee and the University of Tennessee Space Institute. Mary Hiers on Google+

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