4 ms·

What I don’t understand in this story, who and how limited the competition? The product costs a few bucks to produce, retails for $600, and not covered by pate

What I don’t understand in this story, who and how limited the competition? The product costs a few bucks to produce, retails for $600, and not covered by patents: epinephrine discovered in 1901, the autoinjector is derived from military model likely in public domain. How comes no one in the whole US wants to earn billions manufacturing a similar product and selling it for $50?

autokad 10y ago
they may have a patent. dont forget apple patented a shape of a button
- kwhitefoot 10y ago
  The Apple thing is a design patent, what in the UK is called a registered design. Nothing to do with patents as normally meant.
  - autokad 10y ago
    that has much to do with nothing. point being the existence of injectors and the material in them existing before the pen has nothing to do with blocking mylan from having a patent. in which, they indeed do have.
deleted 10y ago
[deleted]
victorhooi 10y ago
There was competitor (Sanofi) but they had a product recall, because it wasn't delivering the right dosage. What people don't seem to understand is - healthcare products are no laughing matter (literally). This isn't like software, where you can release early, release often, and where alpha quality is tolerated (to a degree). For whatever reason, Mylan have done the FDA testing, and perfected a product that works reliably. That is expensive. (I suspect profit factored into it somewhere). There's nothing stopping somebody for designing a different device (like Sanofi) did that does the same job - the devil is in the detail, and making sure you don't f_ck up. Because believe me - the moment you screw up, and deliver the wrong dosage to some kid in anaphylatic shock, and he/she dies...your company is history (or facing a very costly recall and/or potential lawsuit). My daughter recently had a health-scare. That moment, when I looked at her, and honestly thought she wasn't going to make it, was heart-wrenching. So I can tell you, as a parent, if my daughter was allergic to something, and the Epipen was $600, and I needed one around - sure, I'd be bummed about the money, but no, I wouldn't not pay it. And if you told me, these are the only guys so far who have made sure it's reliable, or you can get these cheap 3D printed copy that might work 85% of the time, or she might die but it's only $100 and realy, what's 15%?? What do you think I'm going to go for? If this was like, say, something else that wasn't literally life-saving, then sure, people's risk appetites would probably change dramatically.
- FireBeyond 10y ago
  As a paramedic: So the issue isn't the epi itself (which is just adrenaline). In fact EMS agencies around the country are moving away from the EpiPen (in my state, all ambulance and fire units are required to carry the pen itself) to drawing up from ampoules. In my relatively small county, Medic One throws away $100,000/yr of EpiPens, because they have a short shelf life. "Wrong dosage", though? Dosing epi isn't a particularly exact science - the adult pen is 0.3mL, the junior 0.15mL. Quite often we will have to use multiple pens on the one patient. Underdose is entirely common - especially in civilian-administered situations. Overdose is typically restricted to acute hypertension and associated symptoms which can largely be managed by EMS (who should be enroute anyway for any admin of epi, for reasons not least of which include that 'need for additional dose').
  - victorhooi 10y ago
    Aha, fair enough - I just interpreted what I saw on Sanofi's homepage for the recall: https://www.auvi-q.com/ https://www.auvi-q.com/ > Sanofi US Issues Voluntary Nationwide Recall of All Auvi‑Q® Due to Potential Inaccurate Dosage Delivery > ... > If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. Or is it something that somebody like an EMS would probably not get wrong, but say, a non-medically trained panicked parent could? I've heard the shelf-life complaints about Epipens. For me, I figured it was pretty idiot proof, even for an untrained person in panick mode - take it out, stab it in leg, and that's it, as opposed to trying to drain an ampoule into a syringe. Fortunately, I've never had to face that bad situation....
    - lostlogin 10y ago
      Watching someone with decades of experience in a low stress environment draw up from a glass ampule can be exciting.
    - FireBeyond 10y ago
refurb 10y ago
How comes no one in the whole US wants to earn billions manufacturing a similar product and selling it for $50? One of the biggest reasons is that it's not patent protected. Once a few generic versions hit the market, every manufacturer tries to grab market share by dropping the price. The price of a branded drug usually drops by 80-90% once the generic becomes available. It looks like an attractive market right now, but once a few generics get launched, it won't be as attractive. Mylan is only making hand over fist because others failed to launch their copies.
- ghshephard 10y ago
  To be clear - the patents on epinephrine expired decades ago. (Epininephrine itself was synthesized over 100 years ago). What are still relevant are the patents on the auto-injector. http://webcache.googleusercontent.com/search?q=cache:QZ6wy6bCs3UJ:www.cnbc.com/2016/08/23/epipen-prices-are-out-of-control-heres-how-we-fix-the-problem-commentary.html+&cd=3&hl=en&ct=clnk&gl=sg&client=safari http://webcache.googleusercontent.com/search?q=cache:QZ6wy6b... Designing and testing a new injector is expensive and time consuming. There are certainly new devices coming to market, so the window for Mylan to make money is pretty minimal. In the meantime, there are substitutes that are much cheaper. You can purchase an Adrenaclick from Walmart for $140. http://www.consumerreports.org/drugs/how-to-get-cheaper-epipen-alternative/ http://www.consumerreports.org/drugs/how-to-get-cheaper-epip...
silencio 10y ago
Actually, funny you bring up a $50 price point. The only other autoinjector still on the US market is Adrenaclick, which is ~$140 for a 2 pack. I genuinely have no idea why people consider there to be no viable alternative to the EpiPen - the only guesses I might have are that the third autoinjector (Auvi-Q) being pulled off the market being more "newsworthy", that insurances don't cover it (but $140 is a pre-insurance cash price!), and third but probably most important: people aren't getting prescriptions for something they're not used to using. I have never gotten a prescription for anything but "EpiPen" specifically.
- maxerickson 10y ago
  It's the generic Adrenaclick that is $140. If I have it right, there's 2 companies making the generic.
BurningFrog 10y ago
Several companies are trying, but the FDA keeps rejecting their applications. http://www.nytimes.com/2016/08/24/upshot/the-epipen-a-case-study-in-health-care-system-dysfunction.html?_r=0 http://www.nytimes.com/2016/08/24/upshot/the-epipen-a-case-s...

autokad 10y ago

they may have a patent. dont forget apple patented a shape of a button

kwhitefoot 10y ago
The Apple thing is a design patent, what in the UK is called a registered design. Nothing to do with patents as normally meant.
- autokad 10y ago
  that has much to do with nothing. point being the existence of injectors and the material in them existing before the pen has nothing to do with blocking mylan from having a patent. in which, they indeed do have.

deleted 10y ago

[deleted]

victorhooi 10y ago

There was competitor (Sanofi) but they had a product recall, because it wasn't delivering the right dosage. What people don't seem to understand is - healthcare products are no laughing matter (literally). This isn't like software, where you can release early, release often, and where alpha quality is tolerated (to a degree). For whatever reason, Mylan have done the FDA testing, and perfected a product that works reliably. That is expensive. (I suspect profit factored into it somewhere). There's nothing stopping somebody for designing a different device (like Sanofi) did that does the same job - the devil is in the detail, and making sure you don't f_ck up. Because believe me - the moment you screw up, and deliver the wrong dosage to some kid in anaphylatic shock, and he/she dies...your company is history (or facing a very costly recall and/or potential lawsuit). My daughter recently had a health-scare. That moment, when I looked at her, and honestly thought she wasn't going to make it, was heart-wrenching. So I can tell you, as a parent, if my daughter was allergic to something, and the Epipen was $600, and I needed one around - sure, I'd be bummed about the money, but no, I wouldn't not pay it. And if you told me, these are the only guys so far who have made sure it's reliable, or you can get these cheap 3D printed copy that might work 85% of the time, or she might die but it's only $100 and realy, what's 15%?? What do you think I'm going to go for? If this was like, say, something else that wasn't literally life-saving, then sure, people's risk appetites would probably change dramatically.

FireBeyond 10y ago
As a paramedic: So the issue isn't the epi itself (which is just adrenaline). In fact EMS agencies around the country are moving away from the EpiPen (in my state, all ambulance and fire units are required to carry the pen itself) to drawing up from ampoules. In my relatively small county, Medic One throws away $100,000/yr of EpiPens, because they have a short shelf life. "Wrong dosage", though? Dosing epi isn't a particularly exact science - the adult pen is 0.3mL, the junior 0.15mL. Quite often we will have to use multiple pens on the one patient. Underdose is entirely common - especially in civilian-administered situations. Overdose is typically restricted to acute hypertension and associated symptoms which can largely be managed by EMS (who should be enroute anyway for any admin of epi, for reasons not least of which include that 'need for additional dose').
- victorhooi 10y ago
  Aha, fair enough - I just interpreted what I saw on Sanofi's homepage for the recall: https://www.auvi-q.com/ https://www.auvi-q.com/ > Sanofi US Issues Voluntary Nationwide Recall of All Auvi‑Q® Due to Potential Inaccurate Dosage Delivery > ... > If a patient experiencing a serious allergic reaction (i.e., anaphylaxis) did not receive the intended dose, there could be significant health consequences, including death because anaphylaxis is a potentially life‑threatening condition. As of October 26, 2015, Sanofi has received 26 reports of suspected device malfunctions in the US and Canada. Or is it something that somebody like an EMS would probably not get wrong, but say, a non-medically trained panicked parent could? I've heard the shelf-life complaints about Epipens. For me, I figured it was pretty idiot proof, even for an untrained person in panick mode - take it out, stab it in leg, and that's it, as opposed to trying to drain an ampoule into a syringe. Fortunately, I've never had to face that bad situation....
  - lostlogin 10y ago
    Watching someone with decades of experience in a low stress environment draw up from a glass ampule can be exciting.
  - FireBeyond 10y ago

refurb 10y ago

How comes no one in the whole US wants to earn billions manufacturing a similar product and selling it for $50? One of the biggest reasons is that it's not patent protected. Once a few generic versions hit the market, every manufacturer tries to grab market share by dropping the price. The price of a branded drug usually drops by 80-90% once the generic becomes available. It looks like an attractive market right now, but once a few generics get launched, it won't be as attractive. Mylan is only making hand over fist because others failed to launch their copies.

ghshephard 10y ago
To be clear - the patents on epinephrine expired decades ago. (Epininephrine itself was synthesized over 100 years ago). What are still relevant are the patents on the auto-injector. http://webcache.googleusercontent.com/search?q=cache:QZ6wy6bCs3UJ:www.cnbc.com/2016/08/23/epipen-prices-are-out-of-control-heres-how-we-fix-the-problem-commentary.html+&cd=3&hl=en&ct=clnk&gl=sg&client=safari http://webcache.googleusercontent.com/search?q=cache:QZ6wy6b... Designing and testing a new injector is expensive and time consuming. There are certainly new devices coming to market, so the window for Mylan to make money is pretty minimal. In the meantime, there are substitutes that are much cheaper. You can purchase an Adrenaclick from Walmart for $140. http://www.consumerreports.org/drugs/how-to-get-cheaper-epipen-alternative/ http://www.consumerreports.org/drugs/how-to-get-cheaper-epip...

silencio 10y ago

Actually, funny you bring up a $50 price point. The only other autoinjector still on the US market is Adrenaclick, which is ~$140 for a 2 pack. I genuinely have no idea why people consider there to be no viable alternative to the EpiPen - the only guesses I might have are that the third autoinjector (Auvi-Q) being pulled off the market being more "newsworthy", that insurances don't cover it (but $140 is a pre-insurance cash price!), and third but probably most important: people aren't getting prescriptions for something they're not used to using. I have never gotten a prescription for anything but "EpiPen" specifically.

maxerickson 10y ago
It's the generic Adrenaclick that is $140. If I have it right, there's 2 companies making the generic.

BurningFrog 10y ago

Several companies are trying, but the FDA keeps rejecting their applications. http://www.nytimes.com/2016/08/24/upshot/the-epipen-a-case-study-in-health-care-system-dysfunction.html?_r=0 http://www.nytimes.com/2016/08/24/upshot/the-epipen-a-case-s...