Abler

popsdosh said:
YCBM you may find this interesting aswell.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm422545.htm
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Very interesting thank you. That's actually made me much more likely to trust their products! They have all been tested by the FDA and only one product is out of spec, and that is only just outside the range allowed for an NTI drug (narrow therapeutic index - easy to overdose and underdose) And omeprazole is not an NTI drug I horse, I don't think. Also, I note that the company is Australian, not Indian, so although the drugs are being made in India, they are being overseen by a company based in a stronger regulatory environment.

The US are trying to shut them down but it was two years ago, so presumably they have no jurisdiction. It would be interesting to know if the Australians are trying to shut them down, but since they need to have a much more relaxed approach to veterinary medicine (because of the vast distances vets need to cover), I doubt it. The drug is out of patent, freely available on the internet on various versions, human and horse, so there seems little incentive for anyone except those selling licenced product to persue this.

The problem, as far as I can see, is being caused by pure greed on the part of the two companies who hold a licence. Few would go for an illegal source if they were not trying to take an unreasonable profit off what is now a very common or garden product.

Pfizer have just been given a huge fine for doing the same thing to the NHS. There doesn't seem any interest on the part of the authorities to protect private horse owners in the same way.
 
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ycbm said:
Very interesting thank you. That's actually made me much more likely to trust their products! They have all been tested by the FDA and only one product is out of spec, and that is only just outside the range allowed for an NTI drug (narrow therapeutic index - easy to overdose and underdose) And omeprazole is not an NTI drug I horse, I don't think. Also, I note that the company is Australian, not Indian, so although the drugs are being made in India, they are being overseen by a company based in a stronger regulatory environment.

The US are trying to shut them down but it was two years ago, so presumably they have no jurisdiction. It would be interesting to know if the Australians are trying to shut them down, but since they need to have a much more relaxed approach to veterinary medicine (because of the vast distances vets need to cover), I doubt it. The drug is out of patent, freely available on the internet on various versions, human and horse, so there seems little incentive for anyone except those selling licenced product to persue this.

The problem, as far as I can see, is being caused by pure greed on the part of the two companies who hold a licence. Few would go for an illegal source if they were not trying to take an unreasonable profit off what is now a very common or garden product.

Pfizer have just been given a huge fine for doing the same thing to the NHS. There doesn't seem any interest on the part of the authorities to protect private horse owners in the same way.
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Yes interesting that Registered office is in Australia however again not licenced there or legal to use. What do you call a reasonable profit when you consider what it costs to licence it for a small market. I am sure more would be selling it and gone through the regulatory hurdles if there was such money to be made. Your attitude baffles me regularly Abler are arguably making a bigger profit out of you and breaking the law at the same time.
 
Was GG previously available more cheaply previously? AFAIK GG has always been sold for the same price, by the same company since it was licenced for use in horses?

That was the recent pfizer issue they essentially sold the distribution to a third party who ramped the price up by 2600% ovenight, I don't think the same has happened with GG?

I know everyone loves to hate pharma but we'd be a damn site sicker without them :p.
 
How much does it cost to licence a drug that has already passed all its testing requirements Popsdosh? I don't know. What I do know is that the huge costs for a new drug are to pay for the enormous costs of development and testing, which is why it is given protection for a considerable time. Omeprazole for horse ulcer use is out of patent. Development and testing costs have been recouped. I cannot believe licencing costs alone justify Gastrogard still being sold at the same kind of price it has always been, or its one competitor product to only just undercut them. I think it's price fixing between the two of them, pure and simple.
 
So if it is so profitable why aren't more than the two manufacturing it as a generic?
The companies manufacturing generics do still have to do a fair amount of testing, they have to prove it works the same as the original and is safe etc and gain approval. It isn't a case of just starting manufacture.
 
This was an interesting listen a while back,
I am trying to skip to the bit of how much to produce a generic but pants internet atm!
 
OK, I have looked up licence frees and they are under five thousand pounds. I think that's to hold any number of drugs, but for ease let's assume it's only one. There is also a one-off licence for each import but the cost of that is minimal. If they supply it to one hundred people a year, it adds £50 to the cost of each order. The two companies supplying licenced omeprazole are charging several hundreds more per course, not £50. And I'll eat my hat of they aren't to a lot, lot more people than 100, so the licencing cost is almost immaterial.
 
ycbm said:
How much does it cost to licence a drug that has already passed all its testing requirements Popsdosh? I don't know. What I do know is that the huge costs for a new drug are to pay for the enormous costs of development and testing, which is why it is given protection for a considerable time. Omeprazole for horse ulcer use is out of patent. Development and testing costs have been recouped. I cannot believe licencing costs alone justify Gastrogard still being sold at the same kind of price it has always been, or its one competitor product to only just undercut them. I think it's price fixing between the two of them, pure and simple.
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So why has no other companies jumped on the huge profits bandwagon,surely theres nothing stopping them apart from producing their own product with protective carrier ,licence it and sell and watch their profits go through the roof. Sometimes you just dont want to see the obvious.
 
popsdosh said:
So why has no other companies jumped on the huge profits bandwagon,surely theres nothing stopping them apart from producing their own product with protective carrier ,licence it and sell and watch their profits go through the roof. Sometimes you just dont want to see the obvious.
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Because there are bigger markets elsewhere to make even more profits out of, like the NHS. Pfizer hasn't just been fined £84.2 million for a minor oversight!
 
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ycbm said:
OK, I have looked up licence frees and they are under five thousand pounds. I think that's to hold any number of drugs, but for ease let's assume it's only one. There is also a one-off licence for each import but the cost of that is minimal. If they supply it to one hundred people a year, it adds £50 to the cost of each order. The two companies supplying licenced omeprazole are charging several hundreds more per course, not £50. And I'll eat my hat of they aren't to a lot, lot more people than 100, so the licencing cost is almost immaterial.
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It cost a hell of a lot more than that to get approval for a veterinary medicine LOL if only your figure was accurate , I think you may have found wholesalers licence fees.
 
But if another manufacturer wants to make it isn't just about paying for a licence so I am not sure where you are getting that from? AFAIK licences only come if the initial manufacturer licences you to supply (make? maybe, under their own regulations) their product, ie not really a generic and are happy to sell a licence to you.
It is then being a manufacturer which to do properly takes 3-5 years, it isnt just a get a licence and off you go, that is what I am saying?

Sometimes the ££ of generics is actually more, it depends how much they are selling once it comes off patent.
If lots of companies have taken it on then the price drops, in the case of omeprazole for equine use this hasn't happened so they must have thought/think it not worth the investment at the price sold.
 
popsdosh said:
It cost a hell of a lot more than that to get approval for a veterinary medicine LOL if only your figure was accurate , I think you may have found wholesalers licence fees.
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I think you are confusing developing a drug or testing an existing one for a new use with buying it from an existing manufacturer and selling it. Omeprazole for horse use is an existing drug. Nobody needs to develop it, several companies manufacture omeprazole already.
 
Right, in which case the existing manufacturer has to agree to sell it to you...
do you think they are going to do that if you intend to undercut them by a significant %?

In order to significantly undercut merial you would need to redevelop as a generic, which is how the industry works and how you get lots of companies selling the same active ingredient.
Otherwise why haven't abler bought a licence from merial if it is so cheap and easy to do so?
 
I thought omeprazole for horse use was now a generic. Meaning that a supplier could buy from any of the manufacturers of the drug (there are several) and use it for horses.
 
Do you mean that there are several human generic manufacturers of omeprazole? A generic human manufacturer can not automatically then sell an animal product containing it just because the active ingredient for equine use is out of patent if that is what you mean? Being out of patent doesn't automatically make it a generic unless the abbreviated process as outlined in the link below has been gone through.

FDA so not here but easier to find, as I said earlier, this is what they would have go through.
http://www.fda.gov/AnimalVeterinary...thLiteracy/ucm219207.htm#Generic_Animal_Drugs
 
ycbm said:
Because there are bigger markets elsewhere to make even more profits out of, like the NHS. Pfizer hasn't just been fined £84.2 million for a minor oversight!
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You I am sure will wish to see all my working out however I have just done the maths and was quite shocked to discover how much your theories get blown out of the water.
To make it very simple for you buying 20mg generic omeprazole pills from the cheapest source I could find put each mg at 3.5pence a 500kg horse would require 100 pills at 70p/each so £70/day

At the same dose as recommended of 2000mg (0.71p?mg) the same horse with peptizole would cost £14.20 /day

God their really ripping off the horse owner arent they!!!!

Ive checked my maths twice and it is correct
 
I am astonished that people are so cavalier about breaking the law! Presumably they believe that the law doesn't apply to them, because they are importing animal meds? If they do get caught I hope their career is not dependent on a clean DBS!
 
popsdosh said:
You I am sure will wish to see all my working out however I have just done the maths and was quite shocked to discover how much your theories get blown out of the water.
To make it very simple for you buying 20mg generic omeprazole pills from the cheapest source I could find put each mg at 3.5pence a 500kg horse would require 100 pills at 70p/each so £70/day

At the same dose as recommended of 2000mg (0.71p?mg) the same horse with peptizole would cost £14.20 /day

God their really ripping off the horse owner arent they!!!!

Ive checked my maths twice and it is correct
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All that proves is that the NHS gets ripped off even more! (They buy from the same wholesalers as the ones you looked at). I think the recent Pfizer case already proved that :) I think it's clear from the price Abler can supply at that very big profits are being made by Merial on gastrogard. They had protection for many years to recoup their development costs, but the price remains sky high. Why is that when the development costs have been recouped?


Ester, I understood that Merial is out of time now for charging a licence to make horse omeprazole. Something expired in 2014 or 2015. Do you know what it was, if it wasn't their right to charge a licence fee for manufacture?

I know Boots 'own' ibuprofen, but they obviously don't charge huge licence fees for people to make it.

I don't know enough about how this stuff works, but for a couple of years before the licence expired, people were forecasting a big fall in the price of gastrogard and it hasn't happened.
 
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popsdosh said:
You I am sure will wish to see all my working out however I have just done the maths and was quite shocked to discover how much your theories get blown out of the water.
To make it very simple for you buying 20mg generic omeprazole pills from the cheapest source I could find put each mg at 3.5pence a 500kg horse would require 100 pills at 70p/each so £70/day

At the same dose as recommended of 2000mg (0.71p?mg) the same horse with peptizole would cost £14.20 /day

God their really ripping off the horse owner arent they!!!!

Ive checked my maths twice and it is correct
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You aren't looking in the right place. I've just found 1000 x 20 mg omeprazole for £30. £3 a day against peptizole at £14 and gastrogard even higher.
 
ycbm said:
All that proves is that the NHS gets ripped off even more! (They buy from the same wholesalers as the ones you looked at). I think the recent Pfizer case already proved that :) I think it's clear from the price Abler can supply at that very big profits are being made by Merial on gastrogard. They had protection for many years to recoup their development costs, but the price remains sky high. Why is that when the development costs have been recouped?


Ester, I understood that Merial is out of time now for charging a licence to make horse omeprazole. Something expired in 2014 or 2015. Do you know what it was, if it wasn't their right to charge a licence fee for manufacture?

I know Boots 'own' ibuprofen, but they obviously don't charge huge licence fees for people to make it.

I don't know enough about how this stuff works, but for a couple of years before the licence expired, people were forecasting a big fall in the price of gastrogard and it hasn't happened.
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I think you need a brain transplant sometimes . We can all make whatever knock off product we want and undercut the legit suppliers. You admit yourself you dont know enough about how things work yet are so unswerving in your condemnation of legitimate sources how bizarre! However what i find almost criminal is that you would happily shove an untested and unregulated product down your horses throat to save a few quid .

The VERY simple reason GG has not dropped in price is because no body else has licenced anything to compete with it which in itself says a lot as nothing is stopping them. Is that so difficult to comprehend!

Please show me the figures that prove Merial are making huge profits out of GG , please stop comparing GG with Abler products its like comparing chalk and cheese. If Abler were to go through the regulatory route then you could legitimately compared but they havent and I guess they never will guess they have something to hide.
 
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I've provided as many links as I can so you can know how it works the last one is definitely worth reading as it spells it out. the only reason abler can supply at the price they do is because they have avoided most of the costs others have to sell it legally. What the situation with human medicine is is irrelevant
 
Popsdosh, if Merial were given a protective licence for x years to produce this drug and sell at a high cost to recoup their development costs, and if that protection has now ended because the development costs have been recouped, how could Merial NOT be making huge profits? Just because other drug suppliers have bigger fish to fry doesn't make the current price of omeprazole from a legal source fair.


I would appreciate it if you would hold back on the personal insults. Surely we can discuss things without? Ester does. thank you Ester.

I think this thread has run its course now, I have nothing more to add.
 
ycbm said:
Popsdosh, if Merial were given a protective licence for x years to produce this drug and sell at a high cost to recoup their development costs, and if that protection has now ended because the development costs have been recouped, how could Merial NOT be making huge profits? Just because other drug suppliers have bigger fish to fry doesn't make the current price of omeprazole from a legal source fair.


I would appreciate it if you would hold back on the personal insults. Surely we can discuss things without? Ester does. thank you Ester.

I think this thread has run its course now, I have nothing more to add.
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You are wrong in your assumptions, the licence runs for X years whether you recoupe your development cost or not. You still havent answered the question if merial are making these huge profits why has no other company started selling as a competitor as most companies however much they are selling are always looking for more profits. Peptizole is nearly 20% cheaper than GG yet they still dont drop GG
 
Protective licence? It's a patent, 20 year lifespan regardless of whether costs are recouped or not, though if it is seriously unlikely that they won't be obviously most will either not get to or be taken through the patenting process. Licensing is different.

I suspect more formulations will come along but they don't seem to be rushing that's for sure. Even this paper from 2015 suggests an expected influx http://onlinelibrary.wiley.com/doi/10.1111/jvim.13578/full

Id be interested to know what is stopping abler going through the proper channels and becoming a proper generic if they can prove it works as well.
 
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