The FDA has granted Pfizer a six-month patent extension for any drug containing sildenafil - because the drug giant has been testing the ingredient for pediatric use. The drug in question is Revatio - the medication for pulmonary hypertension - not Viagra, of course, but because they share the same active ingredient, the patent extension applies to both.As a result, the patent for Viagra, which would have expired in 2019, will be extended to April 2020; the patent for Revatio will extend to September for its tablet form, and to May 2013 for its intravenous form. The basic patent for sildenafil itself, which was set to expire in March, will now expire in September.
Federal law grants patent extensions for pediatric testing to give drug companies incentive to test drugs that could be beneficial to children. The exclusivity period prevents competing formulations from entering the marketplace.
Is a patent extension of 6 months really consequential? In the long run, probably not, but it's six months more that competitors have to wait to profit from Viagra knock-offs.
