3 ms·

Pfizer will use this as a way to extend their patents.

by vaadu 14y ago

mistercow 14y ago
My understanding was that one of the criteria for a method-of-use extension is that the patent must not have previously been extended. Since Viagra has already been extended to 2020, I don't think it is eligible for another extension.
danso 14y ago
Some background. In the U.S., there are several characteristics that makes a drug something that the FDA approves: 1) The actual chemical makeup of the drug 2) The dosage of the drug 3) The method of administration for the drug 4. What the drug is intended to treat Therefore, Pfizer can get separate approvals for Viagra if they release 100 mg and 200mg doses. They get separate approvals if the drug is administered through pill or through injection. And they get separate approvals for Viagra if, in one case, Viagra is used to treat erectile dysfunction, and in the other, used to treat, say, ulcers. So, AFAIK, Pfizer can continue making money off of Viagra for this new intended use, if the FDA approves of it. However, I believe (talking from just layman's interpretation here), that this doesn't preclude someone getting a generic approved for erectile dysfunction, after Pfizer's exclusivity period has run out for that particular intended treatment. edit: This is a different issue than when they trivially modify the formulation of a drug in order to delay the possibility of a generic use. The regulations are a bit convoluted so take everything I wrote here with a grain of salt. But tl;dr: there's more to an "approved" product than just chemical formulation.
- refurb 14y ago
  You are correct. If Pfizer conducted clinical trials and got Viagra approved for a new indication, they could extend their exclusivity two different ways: either through a use patent or through market exclusivity as provide by the FDA. However, if their patent is around the use of the drug, i.e. erectile dysfunction and that patent runs out, another company could make a generic. That company would not be able to promote the drug for the new indication, but doctors would know the two were the same and could prescribe the generic.
- rsheridan6 14y ago
  It really shouldn't matter too much. FDA approved indications matter for getting insurance to pay for a drug. Insurance generally doesn't pay for erectile dysfunction drugs or weight loss drugs. The only indication for Viagra (or Revatio, rather, which is the same drug with a different brand name and different indications) that insurance pays for is pulmonary arterial hypertension. Revatio is already generic in the US. The sensible thing to do would be to just use generic Revatio whenever you want sildenafil (generic name of Viagra and Revatio), regardless of the reason you want it.
w1ntermute 14y ago
I wonder if the researchers at the University of Bonn were funded by Pfizer.

Pfizer will use this as a way to extend their patents.

by vaadu 14y ago

Pfizer will use this as a way to extend their patents.

My understanding was that one of the criteria for a method-of-use extension is that the patent must not have previously been extended. Since Viagra has already been extended to 2020, I don't think it is eligible for another extension.

danso 14y ago

Some background. In the U.S., there are several characteristics that makes a drug something that the FDA approves: 1) The actual chemical makeup of the drug 2) The dosage of the drug 3) The method of administration for the drug 4. What the drug is intended to treat Therefore, Pfizer can get separate approvals for Viagra if they release 100 mg and 200mg doses. They get separate approvals if the drug is administered through pill or through injection. And they get separate approvals for Viagra if, in one case, Viagra is used to treat erectile dysfunction, and in the other, used to treat, say, ulcers. So, AFAIK, Pfizer can continue making money off of Viagra for this new intended use, if the FDA approves of it. However, I believe (talking from just layman's interpretation here), that this doesn't preclude someone getting a generic approved for erectile dysfunction, after Pfizer's exclusivity period has run out for that particular intended treatment. edit: This is a different issue than when they trivially modify the formulation of a drug in order to delay the possibility of a generic use. The regulations are a bit convoluted so take everything I wrote here with a grain of salt. But tl;dr: there's more to an "approved" product than just chemical formulation.

refurb 14y ago
You are correct. If Pfizer conducted clinical trials and got Viagra approved for a new indication, they could extend their exclusivity two different ways: either through a use patent or through market exclusivity as provide by the FDA. However, if their patent is around the use of the drug, i.e. erectile dysfunction and that patent runs out, another company could make a generic. That company would not be able to promote the drug for the new indication, but doctors would know the two were the same and could prescribe the generic.
rsheridan6 14y ago
It really shouldn't matter too much. FDA approved indications matter for getting insurance to pay for a drug. Insurance generally doesn't pay for erectile dysfunction drugs or weight loss drugs. The only indication for Viagra (or Revatio, rather, which is the same drug with a different brand name and different indications) that insurance pays for is pulmonary arterial hypertension. Revatio is already generic in the US. The sensible thing to do would be to just use generic Revatio whenever you want sildenafil (generic name of Viagra and Revatio), regardless of the reason you want it.

w1ntermute 14y ago

I wonder if the researchers at the University of Bonn were funded by Pfizer.