You may not know this, but the rules around prescription drugs and exclusivity and the Food and Drug Administration’s rulings are really complex and occasionally shady. Here’s an example: In order to get six more months of exclusive sales of Viagra without generic competition, Pfizer is planning to distribute a children’s form of Viagra under the guise of treating a lung ailment that affects 600 kids each year.
According to the New York Post:
Viagra, which modifies blood flows, could reduce unusually high blood pressure in a child’s lungs, or pulmonary arterial hypertension. Symptoms include dizziness, chest pain and fatigue.
A panel of FDA advisers will determine on Thursday whether to green light the kid’s version.
If Pfizer’s drug meets FDA requirements for children’s treatment, Pfizer would get an extra six months of exclusive Viagra sales without generic competition. Viagra sales in 2009 were $1.89 billion. Its patents expire in 2012.
The application of Viagra is believed to be effective in the treatment of children’s lung ailments with some doctors using a low-dose version of Viagra (called Revatio) since 2002.
The FDA asked Pfizer to create this child-friendly version of Viagra to help children affected with the rare lung disorder in 2001, which Pfizer declined to do until now. Why the sudden change of heart to want to help kids? Presumably due to their desire to extend the patent since, as it currently stands, competitors would be able to sell a generic version of Viagra in 2012, a move which could cut Pfizer’s Viagra profits by half.
So, good news for people who are big fans of kids having healthy lungs and throbbing erections as well as shady corporate maneuvering. And funny, yet slightly misleading, headlines! Which accounts for pretty much all of us, I assume.
Kiddie Viagra may get Pfizer a patent extension [NY Post]









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