Pfizer has won a first approval for OTC Viagra. Viagra Connect, the Pfizer OTC name for its blockbuster erectile dysfunction drug, has been approved for sale in the U.K.
The Medicine and Healthcare products Regulatory Agency (MHRA) announced Tuesday that it will reclassify the 50 mg dose from prescription only to a pharmacy medicine in the U.K. Viagra Connect is expected to be available for sale in the spring of 2018. Anyone seeking to buy the drug will be required to have a discussion with a pharmacist, who will determine whether the drug is appropriate for their use.
Pfizer filed to reclassify Viagra as a pharmacy medicine in the U.K. in March, but had previously filed for the same status almost a decade earlier. Pfizer withdrew its 2008 application after the European Medicines Agency noted concerns. It will continue to sell branded versions of other doses of the drug in the U.K.
Pfizer’s U.K. patent on Viagra expired in 2013, but it will not see its U.S. patent expire until 2020. However, under a settlement with Teva Pharmaceutical, Teva will be allowed to see a generic version of Viagra in the U.S. by the end of this year. Pfizer will continue to sell branded Viagra in the U.S. under its wholly owned subsidiary Greenstone.
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In regard to its U.S. OTC ambitions, Pfizer said, in a statement to FiercePharma, “While we do not have information to share on specific Rx to OTC switch programs in the United States, generally we consider prescription drugs—both within the Pfizer portfolio and outside it—for potential switch to non-prescription status. Our objective is to provide consumers with significantly greater access to medicines with well-established efficacy and safety profiles without a prescription.”
Viagra was approved in 1998 and reached peak sales of more than $2 billion in 2012. Global sales last year topped $1.5 billion, although that was down from $1.7 billion in 2015.
The little blue pill created marketing waves—and controversy—when it was pioneered promoting the ED drug on TV commercials, first hiring former Sen. Bob Dole as a spokesman in 1998. Competitors Cialis, from Eli Lilly, and Levitra, from Bayer and GlaxoSmithKline, soon followed Pfizer’s lead and rushed the airwaves with their own ads. While that led to a rash of consumer complaints about having to explain erectile dysfunction to children who saw the commercials, the ads also helped drive awareness and sales.
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Pfizer continued to push the marketing envelope, and in 2014 introduced what would become its final TV campaign theme. The ads used a never-tried-before bold tactic in which an attractive woman, almost always in a blue dress, would speak directly to the camera to male viewers, saying things like, “You know what? Plenty of guys have this issue—not just getting an erection, but keeping it.”
With the end of exclusivity nearing, Pfizer stopped TV ads for Viagra, with its last airing in May. Competitor Cialis also dropped out of the TV game in anticipation of its own patent loss; it did not buy any upfront NFL ad time, a traditionally strong media placement for both drugs. Lilly has also explored the possibility of an OTC version of Cialis, striking a deal with Sanofi in 2014 to begin work on OTC Cialis to be marketed by Sanofi in the U.S., Europe, Canada and Australia.