Viagra reclassified as an over-the-counter medicine.
For Pfizer and some men in the UK, the second time is the charm. The drug company has received approval from the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK to reclassify its 50-mg dose of the erectile dysfunction drug Viagra as an over-the-counter medicine. The company originally filed to reclassify Viagra as a pharmacy medicine in 2008 with the European Medicines Agency (EMA), but withdrew the application because the agency had concerns.
Viagra Connect will be available for sale in the UK in the spring of 2018. Anyone wishing to purchase the drug over the counter will be required to receive approval from a pharmacist after discussing their health conditions. Branded versions at different doses will continue to be sold as prescription drugs. Viagra lost its patent protection in the UK in 2013.
However, an over-the-counter version won’t be available in the US anytime soon. Viagra has patent protection through 2020. It will have some competition from Teva Pharmaceuticals, however, who won a recent settlement and will begin selling a generic version in the US by the end of 2017. In the US, Viagra is sold through Pfizer’s wholly owned subsidiary Greenstone.
With respect to plans to develop an OTC version of Viagra for the US, the company said in a statement that: “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.”