Kiddie Viagra Could Earn Patent Extension For Pfizer

Viagra for kids? That sounds… well, wrong. But apparently, low doses of the erectile dysfunction drug can help children stricken by a rare lung disorder. It could also earn Pfizer a six-month extension on the patent for its blue-chip brand.

Pulmonary arterial hypertension strikes around 600 children each year, and some doctors have had success treating young patients with small doses of Viagra (produced under the name Revatio).

An FDA advisory panel will meet Thursday to discuss whether or not to recommend approving Revatio.

If the FDA, who originally requested that Pfizer develop the for-kids version of Viagra, gives the thumbs-up to Revatio, Pfizer will be rewarded with a six-month extension of its exclusive patent on Viagra.

The Viagra patent is set to expire in 2012, after which other drug companies would be free to sell generic versions of the drug’s active ingredient, Seldenafil. Considering that Pfizer made $1.89 billion from Viagra in 2009, an extra six months of exclusive sales would be a huge financial windfall for the company.

It would also mean another six months of commercials featuring middle-aged men jamming out to “Viva Viagra” in their garage… Lord help us all.

Kiddie Viagra may get Pfizer a patent extension [NY Post]

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  1. Short_Circuit_City says:

    If the FDA, who originally requested that Pfizer develop the for-kids version of Viagra, gives the thumbs-up…

    I’m sure it’ll be more than just thumbs that go up.

  2. Loias supports harsher punishments against corporations says:

    I really, REALLY don’t want to know how they discovered this ailment was treatable with viagra.

    • Rectilinear Propagation says:

      Well the drug was originally created to treat enlarged hearts. Doesn’t sound that odd that it would help with hypertension in the lungs.

    • eyesack is the boss of the DEFAMATION ZONE says:

      It’s a vasodilator. You can use it for all sorts of stuff (and it’s used off-label for a variety of things).

      But you can make a lot more money off of drugs that do fun stuff than you can from drugs that treat illnesses. So, fixing soft wangs it is, then.

  3. 47ka says:

    Viagra is a PDE-5 inhibitor, which results in the relaxation of smooth muscle in arterioles. Since arterioles are the primary determinant of blood pressure, relaxing them will cause BP to fall.

    Science – not as pedophilic as you might imagine.

  4. JMILLER says:

    How does the same drug just repurposed warrant an extension of their product? It would be like saying you invented the tire, and suddenly decided it could be used in bicycles as well. They can have the extension for the 600 kids only.

    • sirwired says:

      As an incentive to get companies to actually test their medicines in children (instead of leaving it up to doctors to make a Wild Ass Guess at the correct dose), the company receives a 6-month patent extension if they get the drug specifically approved to treat children.

      • Rectilinear Propagation says:

        It’s a rare condition too so I bet the fact that they’ll only gain about 600 more sales didn’t have them jumping to do this until the FDA offered the incentive either.

      • shepd says:

        And if this wasn’t discovered until 7 months from now, what then? Shut down all the generics factories?

        If they want those 600 sales they can work for them the same way everyone else does. Patents are long enough. For crying out loud, the right to use truetype fonts in an open source operating system just became legal. Patents do nothing but slow progress nowadays, IMHO.

        • Promethean Sky says:

          Well, patents do serve a valuable purpose, allowing companies and people to recoup their investment before everyone else jumps into manufacturing their product. That’s not to say that patent law isn’t horribly flawed and unfair, but the concept is good, in my opinion. And I say this as a free information advocate, not an IP supporter.

      • JMILLER says:

        You mean when the patent ran out, none of the other companies that had the opportunity would test for other uses of this drug? You do realize most R&D at pharma is done through the government. In fact, I know some VERY wealthy people due to viagra. Let’s just say Pfizer was not their employer when certain discoveries were made.

  5. diasdiem says:

    Why don’t you have a seat over there.

  6. chaesar says:

    did the catholic church fund this?

  7. Herbz says:

    Side effect: Erections?

    • sonneillon says:

      Side effects may include.
      Morning wood
      Pitching a tent
      Throbbing gristle
      Hard on
      Standing at attention
      Major Chubbby
      Catholic priests making house calls.

  8. youbastid says:

    Wow, so the obvious-but-not-public reason they’re doing this is so they can wring some extra cash out of their adult customers, and the public reason is that 600 sick kids’ parents should have to pay more for a brand name drug vs. having a cheaper generic alternative. What a country!

    • Pepster says:

      WRONG!

      If the drug is approved for use in children, then it becomes coverable by medical insurance. It’s no longer an off-label “experimental” treatment.

      This is a case of the company doing the right thing. Medical testing in children is expensive (lots of liability to insure, for starters), and the 6-month extension is there to help offset the costs so children can get access to new and better drugs.

      • Rickdude says:

        Dude, c’mon! Pfizer isn’t doing this out of the goodness of their heart. They’re exploiting a market. They’ve got a nice side angle that ensures that they keep a valid patent.

        I suspect they spent quite a bit on the legal department in developing this strategy just like they did in clinical trials.

    • wrjohnston91283 says:

      Or Pfizer doesn’t do the R&D, this side use isn’t discovered and approved, and 600 kids a year die who no longer will.

  9. MajorGroove says:

    It’s not like they just figured this out. Pediatric cardiologists have been using sildenafil for pulmonary hypertension for YEARS. They’re waiting until now to test it in order to extend their patent. It’s kind of like how when the patent runs out on one drug, the companies will start marketing a new, “better” version of the drug. Think Prilosec/Nexium, Claritin/Clarinex, and any form of birth control pill imaginable.

    Watch me predict the next use for which they can extend the patent: treatment of Raynaud’s phenomenon. Rheumatologists are already using it for that purpose, and it works well. Watch for this when their current extension runs out.

    • Truthie says:

      The FDA encourages drug companies to study the effects of drugs in pediatric patients by providing a 6 month extension to the drug’s patent protection. It is a standard practice and has absolutely nothing to do with when the studies are started – the pediatric study could be done right after the drug is approved or much later, and it doesn’t matter.

      Considering Congress and the FDA specifically encourage drug companies to undertake studies in children and use the 6 months of extra patent life as a reward, this hardly seems like a cause for outrage. But yes, headlines about kiddie Viagra are funny. Even if the pediatric studies are only for pulmonary arterial hypertension.

  10. bumpducks says:

    Chris- Pulmonary Arterial Hypertension is more appropriately classified as a cardiovascular disease, not a lung disease.

    You should probably clarify that Revatio (that’s Sildenafil) has been approved by the FDA since 2005 for the treatment of pulmonary arterial hypertension in thousands of adults. They will merely determine if the drug is safe for children under the age of 18 as well.

    And I hate to disappoint you, but Revatio comes as a round, white tablet.

    But you do have to admit- the idea of prescribing this to teenage boys is pretty funny.

    And one more thing- you have all heard of the chewable viagra in your spambox, right? Know the most common side effect? It makes your tounge stick out :-)

  11. Grrrrrrr, now with two buns made of bacon. says:

    Well, it would seem that things are looking up for Pfizer.

  12. catnapped says:

    Better lock up your daughters NOW!

    • Coelacanth says:

      I’m probably betting kids with PAH are so sickly, sexual relationships are probably the least of their concern.

  13. Coelacanth says:

    Now all they have to do is formulate Viagra XR, and they’ll greatly extend the patent exclusivity!

    • GamblesAC2 says:

      Viagra XR ” Now you can safely have a boner that lasts for more than four hours…actually it lats for 14.. so you’ll be ready when that moment comes around’

  14. MrEvil says:

    Correct me if I am wrong, but isn’t Viagra simply a Vasodilator? It’s just that Pfizer found out it helps men with ED “get it up” I’m no pharmacist mind you.

  15. AllanG54 says:

    Was it intentional that Revatio and Fellatio rhyme?

  16. lawgirl502 says:

    here’s a new market for illegal pill sales…Viagra junior…for the starter penis

  17. TheMonkeyKing says:

    Great. Now I have that scene for the Woody Allen movie, “Every Thing You Always Wanted to Know About Sex* (*But Were Afraid to Ask).” You know, the one of the mad scientist who has a room full of horny boy scouts.

  18. faceonmars says:

    Last I heard, a year’s supply of Revatio costs about $10,000.00. I bet Pfizer could give it to 600 children for less than $6,000,000. I wonder how much a six month extension of the patent for Viagra is worth?

  19. phudgee says:

    My son has Pulmonary Hypertension and has been taking Viagra since he was 5. He’s 15 now.

    The drug was originally made for heart and BP issues, but the “side effect” was much more marketable.

    And the new drug branded for Hypertension, SHOULD be cheaper and more accessible. We have to fight with our insurance company every year at renewal because some goon sitting at the desk sees a kid with a viagra prescription and denies it. So we spend Jan and Feb of every year talking to the Pharmacist, Doctors, and Insurance company to get the approval through. With the rebrand, this problem should go away.

    We currently pay the same price everyone else does for Viagra, and for the Hypertension issue, it is WAY overpriced. its over $1500 a month. The rebranded version is supposedly going to be cheaper.