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FDA Approves First Generic Version of EpiPen (go.com)
An anonymous reader quotes a report from ABC News: The U.S. Food and Drug Administration has approved the first generic version of the EpiPen and EpiPen Jr auto injector for the emergency treatment of allergic reactions. The approval is part of the FDA's "longstanding commitment" to providing access to low-cost generic alternatives, FDA Commissioner Scott Gottlieb said in a statement. It is unclear how much the generic product -- manufactured by Teva Pharmaceuticals -- will cost. In August 2016, Mylan Pharmaceuticals was criticized for raising the price of a two-pack of EpiPens to $600. The price of two EpiPens was about $100 in 2009. The brand name version is by far the most popular epinephrine auto-injector on the market. "This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," said FDA Commissioner Scott Gottlieb in a statement.
Generic of course.
I'm just curious, why are Epi Pens not already generic?
Then observe the value of competition... The market works, if you let it.
"File to fit, pound to insert, paint to match" - Aircraft Maintenance 101
Genuine brand named EpiPen's in New Zealand are $NZ120 each. They never skyrocketed like they did in USA.
The government usually replaces used epipens too, as everyone here is covered medically for accidents and anaphylaxis is usually caused by an accident.
Can you even buy Anapen's in USA? They're an alternative available in most countries. They've been around since 2010.
Natural monopoly by the incumbent.
Generic: "Hey, we could make generic Epipens for about $100 each. The brand name costs $600. Let's sell them for $200 and undercut"
Incumbent: (Cuts price to $100. Eats small loss per unit)
Generic: (Goes bankrupt)
Incumbent: (Raises price back to $600, recoups losses)
In part because the FDA requires each producer to re-test the proven design so much to prove it really is exactly like the already approved one that it's almost as expensive as introducing something new, but with a lot less potential for profit.
Then you get overly specific legislation like when schools are required to have $600 epi-pens on hand rather than $10 pre-filled with epinephrine syringes.
This is just another example of the absurdity of prescription drugs. Obviously there's no reason for Epi Pens to be that expensive, since they weren't that expensive long ago. The real reason for the expense was because a lot of places were required to buy them. Kids are allergic to everything these days (seriously), and so schools need to have epi pens. Would you send your toddler to a preschool without an epi pen? Think of the children! So that cost could be hidden in the budget of "safety" for schools. If you were a consumer, you could avoid them. I had allergy shots and my provider gave me an epi pen prescription. I didn't really need it, but it was in the 1 in a 1000 chance I had a reaction when I wasn't around. But she also gave me a coupon to make it go down to a reasonable cost. But now there's an outcry about this absurdity, and so we get another option. This fixes the tiny problem, allows the drug companies to still make handfuls of money, and no one talks about what is really needed in the US: the government as the only buyer of drugs. If drugs are such that there is only one supplier, with patent protections that give a monopoly on production, there should be a single buyer, that would negotiate an acceptable price, and then this buyer sells to all pharmacies at cost, which leads to an equitable distribution.
I'm not so sure it'd be appropriate to call a medical product 'popular' when the only reason it makes its sales is because up until now they were the only ones legally allowed to produce this life saving device in the US.
It's not like Mylan raised the price of their epipens to 600 bucks because they're the Apple of EpiPens here. People either had to cough up the cash or die. Consider that an EpiPen costs $30 to manufacture. (yeah yeah sure, there's shipping costs and the like. But I'm pretty sure they weren't using SpaceX to ship their EpiPens from Pensylvannia, to the rest of the US)
EpiPens are not already generic because every time you change the delivery mechanism, you restart the patent timer. Yeah, they made a minor change to the mechanism to keep it patentable. How that prevents competitors from using the old mechanism is beyond me.
I've abandoned my search for truth; now I'm just looking for some useful delusions.
I think you're forgetting the part where the government forbids the sale of the generic completely. As has been the case up until now.
Also, if this were a common and accurate portrayal of events, why am I able to buy generic versions of many other types of drugs and medications? Shouldn't this have happened in ever other instance as well?
Read the article. These new ones are not really actually generic either. It's still Mylan screwing over customers. They are simply changing the branding and the branding only and charging less, not a lot less though. It's still going to be about $300 for 2 pens...
They are doing this in a really shitty attempt to save face. It's not going to work.
Your question is a valid one, why is there not a generic? Also, why is another company not creating a generic. This is no different than Chevy vs GMC. The same fucking truck, same features, same materials, built on the same assembly lines, but with different logos and different costs. Mylan has now 2 brands to sell and make even more money off of.
Generic: "Hey, we could make generic Epipens for about $100 each. The brand name costs $600. Let's sell them for $200 and undercut"
Incumbent: (Cuts price to $100. Eats small loss per unit)
Generic: (Goes bankrupt)
Incumbent: (Raises price back to $600, recoups losses)
Except your price estimates are a bit off. Experts say the actual cost of manufacture to Mylan is likely only $20 to $30 per pen.
http://time.com/money/4481786/how-much-epipen-costs-to-make/
Jeebus, I can understand not knowing how the process works, but really you can't make it past the damn headline without incorporating the relevant information ?
FDA Approves First Generic Version of EpiPen
That is why there was no generic on the market, none were improved. Now if you want to go poking fingers about how horrible the system is, the CEO of Meylan (Heather Bresch) is Joe Manchin's daughter and oddly enough the FDA has been curiously well disposed towards his little girl's company
http://fortune.com/2016/09/07/...
Oh and he's a Democrat by the way, something to remember the next time they promise free healthcare.
part because the FDA requires each producer to re-test the proven design so much to prove it really is exactly like the already approved one that it's almost as expensive as introducing something new, but with a lot less potential for profit.
As someone who has done this repeatedly, I can tell you that proving equivalency is an order of magnitude cheaper than proving a new design.
Teva is an Israeli company. As far as I can tell, it has no links to Mylan. If you know differently, care to share?
> Actually, there is less than $1 of epinephrine in each Epipen.
That remark would be relevant if you were only getting the drug. Since you aren't just getting the drug but also the delivery system, that remark is utter nonsense.
This is precisely the kind of inane bullshit that completely pollutes discussion of this issue.
A Pirate and a Puritan look the same on a balance sheet.
> What makes your think Orange Julius Caesar had anything to do with this?
This didn't happen during the administration of your lord and savior.
A Pirate and a Puritan look the same on a balance sheet.
Apparently Insulin has shot up in recent years. It seems crazy it should cost much at all, it's been made forever...
"There is more worth loving than we have strength to love." - Brian Jay Stanley
The FDA doesn't just approve generics that do not exist yet. Someone has to decide to make a generic, and then seek FDA approval.
With Mylan's anticompetitive history, anyone wading into this space knows that Mylan will slash their price to drive the generic out of the market. So no one decided to lose a giant pile of money developing a generic.
This particular company is betting that Mylan has attracted enough scrutiny that they won't be able to do it without antitrust regulators going after Mylan. We'll see if they pull it off.
Mylan has patent protection that lasts through 2025. So why is a generic version coming to market now?
Mylan to launch generic version of EpiPen, at half the cost
why am I able to buy generic versions of many other types of drugs and medications?
Pills are relatively cheap and easy to develop. Mix drug with already-approved filler and you're basically done.
Autoinjectors are more complicated and require more FDA approvals, since it's both a drug and a medical device. That means longer R&D time and R&D cost, which makes it easier for Mylan to harm the competitor much more than Mylan.
Plus, Mylan has been significantly more aggressive on pricing than other companies, so the assumption has been they would be aggressive here too.
Because they existed before 2009, but Mylan changed the design slightly around then and reapplied for a patent on the "new improved" design.
This generic can be exactly the same as a pre-2009 model and still work just fine.