Pfizer Gets 6-Month Patent Extensions For Viagra, Revatio
Pfizer Inc.'s (PFE) blockbuster anti-impotence pill Viagra has been granted an further six months of U.S. patent protection--because the organization studied the drug's active ingredient in kids.
Don't worry, Pfizer is not planning to industry Viagra to youngsters.
The extra exclusivity arises for the reason that Viagra shares an active ingredient, sildenafil, with a different Pfizer drug, Revatio, which can be marketed to treat pulmonary arterial hypertension, or high blood pressure within the lung's arteries.
The U.S. Food and Drug Administration previously asked Pfizer to test Revatio in children with pulmonary hypertension. Pfizer conducted the studies and has applied for FDA approval to market Revatio for use in kids; an FDA decision is expected in Could.
Federal law offers for such extensions of exclusivity as an incentive for drug makers to test items that may perhaps be valuable to youngsters. In the course of exclusivity periods, competing generic copies are normally prohibited from entering the market place. The FDA granted the six-month pediatric extension for sildenafil on Feb. 9, in accordance with the FDA internet site.
The patent extension applies to any drug containing sildenafil, even Viagra, which is only approved for use by men with erectile dysfunction and not for use by youngsters.
As a result, the U.S. period of exclusivity for Viagra would extend by six months till April 2020, mentioned Pfizer spokeswoman Victoria Davis. That is definitely depending on a patent thanks to expire in 2019, which covers sildenafil's use to treat ED. This patent was upheld by a federal judge last year, though Teva Pharmaceutical Industries Ltd. (TEVA), which challenged the patent's validity, has appealed that decision.
The fundamental patent for sildenafil was on account of expire in March 2012. The pediatric exclusivity period now extends to September.
The U.S. periods of exclusivity for Revatio will extend to September for its tablet formulation, and to May well 2013 for its intravenous formulation, Davis stated.
Pfizer recorded Viagra sales of $1.98 billion for 2011, and $535 million for Revatio.
Pfizer shares declined 13 cents to $21.20 in recent trading Friday.
Don't worry, Pfizer is not planning to industry Viagra to youngsters.
The extra exclusivity arises for the reason that Viagra shares an active ingredient, sildenafil, with a different Pfizer drug, Revatio, which can be marketed to treat pulmonary arterial hypertension, or high blood pressure within the lung's arteries.
The U.S. Food and Drug Administration previously asked Pfizer to test Revatio in children with pulmonary hypertension. Pfizer conducted the studies and has applied for FDA approval to market Revatio for use in kids; an FDA decision is expected in Could.
Federal law offers for such extensions of exclusivity as an incentive for drug makers to test items that may perhaps be valuable to youngsters. In the course of exclusivity periods, competing generic copies are normally prohibited from entering the market place. The FDA granted the six-month pediatric extension for sildenafil on Feb. 9, in accordance with the FDA internet site.
The patent extension applies to any drug containing sildenafil, even Viagra, which is only approved for use by men with erectile dysfunction and not for use by youngsters.
As a result, the U.S. period of exclusivity for Viagra would extend by six months till April 2020, mentioned Pfizer spokeswoman Victoria Davis. That is definitely depending on a patent thanks to expire in 2019, which covers sildenafil's use to treat ED. This patent was upheld by a federal judge last year, though Teva Pharmaceutical Industries Ltd. (TEVA), which challenged the patent's validity, has appealed that decision.
The fundamental patent for sildenafil was on account of expire in March 2012. The pediatric exclusivity period now extends to September.
The U.S. periods of exclusivity for Revatio will extend to September for its tablet formulation, and to May well 2013 for its intravenous formulation, Davis stated.
Pfizer recorded Viagra sales of $1.98 billion for 2011, and $535 million for Revatio.
Pfizer shares declined 13 cents to $21.20 in recent trading Friday.
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