Going by the usual schedule of name brand drugs going off-patent, there would have been generics in 2012. However, Pfizer actually holds two patents for Viagra: the first for the composition of the drug (which expired in 2012), and a second “method-of-treatment” patent, which won’t expire until April 2020.
The method-of-treatment patent covers the specific indication of Viagra for treatment of erectile dysfunction (ED). It’s slightly unusual that Pfizer won the court case upholding its method-of-treatment patent, but the company was able to do so because of the way the drug was developed. Sildenafil, the active ingredient in Viagra, was first studied as a treatment for blood pressure problems, and the drug’s effects on ED were only discovered by accident. This happy discovery allowed Pfizer to gain a second patent a few years later, which will remain in effect until April 2020.
What Teva Pharmaceuticals USA Agreed To
So if Pfizer’s method-of-treatment patent doesn’t expire until 2020, why will Teva Pharmaceuticals USA get to sell a generic version of Viagra in the US in 2017? Teva entered into an agreement with Pfizer that it will be able to enter the market on December 11, 2017 and will pay patent royalties to Pfizer through April 2020. There were apparently other settlement terms, but they have not been disclosed.
Teva and Pfizer have been in court before. Back in 2010, Pfizer sued Teva over their plans to bring a generic version of Viagra to the US in 2012. This was when Pfizer prevailed due to its method-of-treatment patent, the one that doesn’t expire until 2020. Pharmaceutical developers like Pfizer, naturally, want to keep generics out of the picture for as long as possible, because the introduction of less expensive generic competitors causes sales of name brand versions to plunge.
What It Means for the US Consumer
Unless other drug companies make their own deals with Pfizer, you shouldn’t hold your breath about other generic versions of Viagra appearing on the scene until 2020, when the method-of-use patent finally expires. However, the patent for Cialis also expires in 2017, and when this happens, you may see generic competitors that use tadalafil, the active ingredient in Cialis.
The 1984 Drug Price Competition and Patent Term Restoration Act, also called the “Hatch-Waxman” Act after its sponsors, was designed to encourage the manufacture of generic drugs. This law has been interpreted as giving 180 days of generic exclusivity to the first generic company to file for FDA approval. This facilitates patent-holders paying the first generic manufacturer to delay entry into the market by offering a period where the generic will be the only generic on the market. Other generics can’t enter the market until the 180-day period either expires or is forfeited. So if Teva holds onto exclusivity starting in April 2020, when Pfizer’s patent expires, you may not see other generics in the US till later that year.
Generics in Europe
In June 2013, Pfizer’s patent expired in several European countries, allowing manufacturers to sell generic versions of Viagra there. Three manufacturers, Actavis, Teva, and Mylan, started selling generics, and in some European countries, generics from all three brands are now available. Prices in the UK alone fell from around US$15 per tablet to around US$1.50 per tablet almost immediately.
The agreement between Pfizer and Teva for the US market has not had much of an effect on either company, though share prices for Pfizer dropped a bit after the announcement, and share prices for Teva rose modestly on the news. Viagra is still very profitable for Pfizer, despite the introduction of generics in other countries. The drug still brings Pfizer over $1 billion a year in the US alone.
Viagra was a game-changer for the pharmaceutical industry, for men, and some would say for society overall. It’s still the most widely counterfeited drug in the world and is more of a household name than other ED treatments. Genuine Viagra manufactured by Pfizer is available from eDrugstore.com, with speedy, discreet shipping, providing the ultimate in convenience. eDrugstore.com is HIPAA-compliant and adheres to the most stringent practices in ensuring online ordering security and customer privacy and satisfaction.
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