Do you know how much it costs to produce the device and meet all the likely regulations? I would have thought this is to only break even. It's more a marketing move to be the good side in the story and get more business from ethical followers.
Given the $600 of the original, I'd say $109 is cheap.
EpiPens are medical devices, not drugs, so the regulatory approval process is significantly different. Whereas drugs usually take around 15 years and about a billion dollars to develop and approve, medical devices can take as little as 3 years and $25 million. For example, the entire approval process for the Revo MRI-conditional pacemaker was less than two years [1] (although companies enter an active dialog with regulators long before submitting the application).
The prescription you get for adrenaline is actually for the autoinjector mechanism, which is significantly cheaper to develop and test than a pacemaker, so I'd bet the numbers are at most 5 years/$50 million.
That's not quite accurate. It's a device/drug combination. The manufacturer still has to produce the drug under GMP conditions and get an aNDA approved for the drug portion.
One could argue it's more expensive than just a medical device.
I was oversimplifying, but yes the manufacturer still has to prove that their drug is equivalent to the gold standard for therapeutic uses and that they have sufficient quality control. How much it costs depends on the complexity of the drug and who does it. An experienced generic drug manufacturer will have everything in place for patient selection, investigators on their payroll, and expertise in designing protocols for the marketing application. Since we're talking about adrenaline, not some complex drug cocktail, I think the device portion would make up the majority of the cost (life and death emeregency device + has to work in the field without a medical professional tends to be pricey).
Even if they buy the epinephrine they use, they still need to validate the purity, do a sterile fill of the device, track stability in the device, etc.
It's not like they could buy a 100 kg of epinephrine, dissolve it up and just fill syringes with it.
Given the $600 of the original, I'd say $109 is cheap.