Levothyroxine - generic or 'named' or T3 - Thyroid UK

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Levothyroxine - generic or 'named' or T3

shaws
shawsAdministrator

Were you aware that generic levothyroxine is not the same as Eltroxin or other 'named' levothyroxines? I know Eltroxin used to be prescribed in the UK - I think it has been withdrawn in favour of generic levothyroxines.

restartmed.com/synthroid-vs...

This is from TUK which many might find informative.

thyroiduk.org.uk/tuk/treatm...

18 Replies
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The generics are introduced when a drug runs out of patent. The manufacturers have to demonstrate that they are 'equivalent', this involves showing they deliver the same amount of the drug as the original. The branded and generic versions will differ to some extent in fillers etc and some patients will notice a difference. In most cases it will simply be a matter of absorbing a little more or a little less. I have never noticed any difference in levothyroxine tablets except once when I switched from 100 mcg to 50 mcg, I now prefer to split 100 mcg tablets to get my 50 mcg dose.

A few patients notice a big difference between different brands of levothyroxine, it makes sense that they stick to the same brand. There's no reason why the original branded version should be better than a generic, the original branded drug is simply the first generic!

Eltroxin is still available but the manufacturers are making it difficult to obtain. I suspect they want to ditch it as it is small volume now. It is price controlled and although more expensive than generics it does set a cap on future price increases. Eltroxin is marketed by Concordia / AMCo who market UK liothyronine. In 2014 AMCo announced that their generic levothyroxine is identical to Eltroxin concordiarxinternational.co... .

I have tried Concordia Eltroxin and it is nothing like Goldshield Eltroxin the original Eltroxin in UK. There have been many posts in the past about this.

I thought it had to have the same formulation but perhaps they are allowed to make some changes. I certainly get the impression that Tertroxin (liothyronine) dropped in quality after Goldshield sold it on. I believe (i.e. I'm not sure) that quality control is left entirely up to the manufacturer and so there is scope for cost cutting and reduced standards.

helvella
helvellaAdministrator in reply to jimh111

I believe (i.e. I'm not sure) that quality control is left entirely up to the manufacturer and so there is scope for cost cutting and reduced standards.

We have seen the claim/suggestion that Mercury Pharma liothyronine is tested on a batch by batch basis by the MHRA and we have to assume that is because of a history of inadequate quality control by the company.

jimh111
jimh111 in reply to helvella

Last year I sent a freedom of information request to the MHRA about AMCo liothyronine and received a response in September 2017 which revealed that over the previous five years there were 17 ‘pharmaceutical batch specific variations type II’. Type II variations are classed as serious. This indicates that the liothyronine failed to meet the requirements of a generic medicine (equivalent to the reference drug ‘Tertroxin’) and had to be approved on a batch by batch basis. There were also two type IB pharmaceutical variations.

On 29/04/2014 there was a type IB variation reducing the shelf life of liothyronine from 36 to 24 months and another variation on 31/03/2016 reducing it from 24 to 12 months. I assume this is because they found the drug deteriorates after 12 months. AMCo did not recall the tablets that were incorrectly sold with 36 or 24-month shelf lives.

Subsequent to me putting this on a forum one patient who wrote to AMCo was told the reason their liothyronine is so expensive is that it needs to be tested on a batch by batch basis! What a cheek, their liothyronine has to cost so much because it is crap!

I submitted another FOI request to the MHRA asking if Morningside and Teva liothyronine is also subject to batch variations. I received the reply ‘We are exempting your request under Section 41 of the FOI Act (Information provided in confidence), as the release of this would likely result in legal action against the agency’. It looks like these companies are leaning on the MHRA and stopping them revealing information. I would be grateful if some other patients could request a list of batch variations for liothyronine over the previous year. Perhaps if the MHRA gets a lot of requests they might feel able to reveal the information (information we pay for as tax payers).

I’m fairly sure the MHRA doesn’t do any testing, they tell the manufacturer to do it. This seems a bit silly as they are left at the mercy of the manufacturer, there should be independent verification. (I’m not sure of my facts on this).

Something certainly went wrong with Amco Levo in 2010. My thoughts are that they either did not heat treat the Acacia Powder or used the wrong one,Acacia Rigidula. However, I have taken this to the top with the Health Ombudsman and have got nowhere. When something goes wrong with a medication it is not, evidently, in their remit! I wonder what is!

shaws
shawsAdministrator in reply to nightingale-56

All we know is that we're unwell and initially don't know if it us or the pill we take. They seem to have the knack of avoiding taking the blame.

helvella
helvellaAdministrator in reply to jimh111

The generics are introduced when a drug runs out of patent.

I do not believe that either levothyroxine or liothyronine ever were patented in the UK or the USA. (I have never looked further afield so cannot comment on anywhere else.)

jimh111
jimh111 in reply to helvella

This document gives some information on generics britishgenerics.co.uk/about... . It's from a highly biased source, so read with care. They refer to the 'originator product', i.e. the original branded medicine. I guess I'm assuming a branded product would have a patent, otherwise someone else could use the brand name. So I would expect that Eltroxin was patented. The generic has to be 'bioequivalent' which is a rather vague term but means essentially it delivers the same amount of active ingredient.

A further complication is that companies are now introducing 'branded generics'! Generics they give a trade name to in the hope that it can be priced higher than other generics.

helvella
helvellaAdministrator in reply to jimh111

Ownership of a brand name does not imply ownership, or even existence, of a patent!

For example, Tertroxin is a registered trade mark:

trademarks.ipo.gov.uk/ipo-t...

As is Eltroxin:

trademarks.ipo.gov.uk/ipo-t...

But neither is in patent in the UK.

jimh111
jimh111 in reply to helvella

Yes you're right Tertroxin is a trade mark rather than a patent. I don't know how it works but I believe other companies could not make generics until the 'patent' expired. This document nhs.uk/conditions/medicines... seems to imply all new drugs have patents but I've no idea of how to check whether there was ever a UK patent on Tertroxin.

helvella
helvellaAdministrator in reply to jimh111

The European Patent Office seems like a good starting place!

worldwide.espacenet.com/sea...

I have checked several times and have never found a patent for either liothyronine or levothyroxine themselves in the UK or the USA - though derivative products such as gel for eyes could, of course, have been patented. Indeed, I have seen it expressly stated that they were not patented.

If I invented a new medicine, I could choose to disclose it rather than patent it. This technique is often used by companies to ensure that no other company can patent what they have identified/invented.

Also of interest, Salk and polio vaccine:

en.wikipedia.org/wiki/Jonas...

helvella
helvellaAdministrator in reply to jimh111

If it weren't so very serious, I'd have laughed my head off at this from the link you posted:

The UK has a competitive, multi-source generic market which keeps medicine prices at the some of the lowest in Europe. Generic competition - which occurs when a branded product loses its patent protection – reduces prices by as much as 90%.

Just how does that square with the costs of liothyronine which is now in what I consider amounts to an oligopoly?

jimh111
jimh111 in reply to helvella

I did say it was highly biased! Just extract the morsels of useful information and ignore (or laugh at) the rest.

shaws
shawsAdministrator in reply to helvella

What is the phrase:-

"Lies and more lies" ?

It is more than ridiculous that companies can pull a figure out of a hat and it doesn't matter who pays the price i.e. the NHS or, more importantly, patients when it is withdrawn due to cost and not because it is inferior in some way. Considering there was hope amongst patients that, at last, we'd have reasonably priced T3 but found there was/is absolutely no alternative/competion between the three companies charging an arm and leg for one packet of T3.

It is about time there was a thorough invesigation into who is totally responsible for the fiasco which has arisen.

How did all three companies arrive at similar costings?

When my son and I were changed to Amco Levo, our blood test results were about the same as usual, but our skin suffered terribly an I had an awful glue-like taste in my mouth, after 3/4 months. Eventually I could taste shampoo in my mouth and also bleach when I had my hair coloured. I am a very nice shade of salt and pepper now, but frightened to colour it again, as can still taste glue in my mouth, and have lumps on my skin.

shaws
shawsAdministrator in reply to nightingale-56

That sounds absolutely horrible and we don't realise how much we rely on our 'taste buds' to avoid swallowing something we shouldn't. If skin is aggravated too - very, very unpleasant.

I think it's very misleading to say something like that without explaining why.

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