Liothyronine patent: Why if liothyronine was... - Thyroid UK

Thyroid UK

112,247 members130,569 posts

Liothyronine patent

paradime
paradime

Why if liothyronine was licenced in 1956 did it not go out of patent till 2007, were patents for 50 years back then? I have read that it was re-branded but surely that does not make it new, just a new name?

35 Replies
oldestnewest
RedApple
RedAppleAdministrator

Welcome to the forum paradime. Where are you getting this information about liothyronine licensing and patenting from?

paradime
paradime in reply to RedApple

T'interweb. Why, is it not correct according to your reading? Am I meant to record and quote sources? I read, first licenced 1956 and deregulated 2007. Then total of 60fold price rises since and no competition as Concordia are on a sole supplier contract to NHS. Is this not right?

I believe it was out of patent. Liothyronine was (and still is I think) sold as the branded drug Tertroxin. Branded drugs are subject to price control. Generics are not because it is assumed that competition will keep the price down. The manufacturers 'debranded' Tertroxin so they could escape price regulation and increase the price.

paradime
paradime in reply to jimh111

Yes, thanks I knew all that. Why a 50 yr patent to 2007? Why a sole supplier contract for a generic? Amounts to worst than extending the patent ,as you point out, patent med prices are regulated.

SlowDragon
SlowDragonAdministrator in reply to paradime

Blatant exploitation of loop hole on generic medication

Similar was going on with special prescriptions too ....including named non-U.K. brands of T3

express.co.uk/news/uk/91348...

paradime
paradime in reply to jimh111

Tertroxin is brand of Mayne Pharma US. Cytomel is Pfizer. Believe Concordia are now Advanz Pharma and have move HQ to UK from Canada (and are laughing all the way to the bank - which bank and where I don't know). Can't find the brand name of liothyronine from Advanz, but it does not matter as CCG says my endo may not prescribe it for me as it is too expensive.

SlowDragon
SlowDragonAdministrator in reply to paradime

There are now 3 licensed suppliers of T3 to NHS

Mercury Pharma

Morningside healthcare

Teva

Price has inched slowly downwards from £268 for 28 tablets, at its most expensive ....now down to £160ish

Obviously still way above EU prices.

Private prescription enables access to cheap T3 from Germany- Thybon Henning is 31 euro for 100 x 20mcg

paradime
paradime in reply to SlowDragon

That is very interesting, 3 licensed and prices coming down. I had gathered something about advanz/concordia having a sole supplier contract. Perhaps things are getting better. Have Competition and Monopolies Authority, CMA , put the boot in? Still a swindle for an old med costing pennies to produce. At what price do we think CCGs will allow it to be prescribed?

Having been crippled for 44 yrs I can't really afford private prescriptions or even German prices.

SlowDragon
SlowDragonAdministrator in reply to paradime

There are quite a few of us do get prescribed T3 on NHS

Some CCG areas better than others - Kernow good. Brighton terrible

If your nhs endocrinologist says you have clinical need you should be prescribed. Initial 3-6 months trial via endo hospital pharmacy. Assuming trial is ok, endo writes to your GP to formally request they take over on going care (and cost of prescription) ....sometimes endo needs to do an individual funding request on your behalf. Annual review back with endo

Testing positive for Dio2 gene variation can help persuade NHS to fund.

thyroiduk.org/getting-a-dia...

Confirmed gluten intolerance good reason too

According to the latest Open Prescribing Report, Bath&North East Somerset CCG have NO prescriptions for Liothyronine whereas a couple of months ago they had 11. It seems they have managed to get all patients who were on it, off it. I have recently been told that I do not “qualify” for a prescription on the NHS with a suppressed TSH, an over range, by quite a way, FT4 and an FT3 struggling to meet 50%, however, NHS Endo happy to monitor me provided I buy my own - but he won’t give me a private prescription. This situation is absolutely diabolical

SlowDragon
SlowDragonAdministrator in reply to Gingernut44

Utterly unacceptable

Write to GMC, your MP and CCG

If an NHS endocrinologist says you have clinical need of T3 they should prescribe. As per National guidelines

Not acceptable to be told to buy online from dubious/criminal suppliers

I totally agree. I feel sorry for those who’ve had it taken away. I don’t know if any of them are on this forum but they should be. Perhaps I will open a new post asking that question and maybe we can get together.

SlowDragon
SlowDragonAdministrator in reply to Gingernut44

There’s at least around 7000 patients had T3 prescription stopped .....previously used to be approx 13,000 prescribed, now around 6000.

In reality probably at least 100,000 - 200,000 need it. There’s 2 million people in the UK on levothyroxine

SlowDragon
SlowDragonAdministrator in reply to paradime

NHS England Liothyronine guidelines July 2019 clearly state on page 13 that TSH should be between 0.4-1.5 when treated with just Levothyroxine

Note that it says test should be in morning BEFORE taking Levo thyroxine

Also to test vitamin D, folate, B12 and ferritin

If Ft3 remains low, trial of T3 possible

sps.nhs.uk/wp-content/uploa...

Email Dionne at Thyroid UK for list of recommend thyroid specialist endocrinologists who will prescribe T3

tukadmin@thyroiduk.org

helvella
helvellaAdministrator in reply to paradime

The UK system usually requires companies apply for licences.

If none do, then the one company is effectively a monopoly supplier. That company has no say in whether other companies apply for licences. (Though who knows what arm-twisting might occur?)

Our medicine acquisition system is, simply, not up to the job. A rational system would have allowed the NHS to import another EU. Just on the basis of dual-sourcing to maintain resilience of supply would, in my view, be sufficient argument.

SlowDragon
SlowDragonAdministrator in reply to paradime

Website showing prescription rates of T3 across English CCG areas

openprescribing.net/analyse...

helvella
helvellaAdministrator in reply to paradime

Tertroxin is not a brand of Mayne Pharma.

Cytomel is an oddity. In the USA, the brand has been owned by Pfizer but I think they have been disposing of some products. Would have to check to be sure.

In the Netherlands, Cytomel branding is used by Ace Pharma. It is a different formulation to that of Pfizer Cytomel.

Advanz own Mercury Pharma and their liothyronine product is sold in the UK without branding, just as Mercury Pharma liothyronine, but the same product is sold elsewhere, e.g. Australia, as Tertroxin. I think that Aspen actually supply to the Australian market - quite possibly they handle all exports of Tertroxin.

UK Liothyronine Tablets and Oral Solutions

➖➖➖➖➖➖➖➖➖➖➖➖➖➖

Last updated 15/09/2020.

This is a list of currently marketed liothyronine tablets in the UK.

Please note that re-branding (whether by a manufacturer or as an ‘own label supplier’) – which has happened with several products – does not mean any change to formulation.

—————————————————————

🔹 Advanz (marketing authorisation holder) – branded Mercury Pharma (also branded Tertroxin but not marketed under that brand in the UK)

🏭 Custom Pharmaceuticals Ltd. (manufacturer)

🥛 contains lactose

  20 microgram  PL 10972-0033

🟢 PIL mhraproducts4853.blob.core....

🟣 SPC mhraproducts4853.blob.core....

—————————————————————

🔹 Morningside (marketing authorisation holder) – branded Morningside Liothyronine and Iraksin

🏭 Morningside Pharmaceuticals Ltd. (manufacturer)

🥛 contains lactose

  5 microgram  PL 20117-0323

  10 microgram  PL 20117-0324

  20 microgram  PL 20117-027

🟢 PIL Morningside Liothyronine & Iraksin 5, 10 & 20 microgram mhraproducts4853.blob.core....

🟣 SPC Morningside Liothyronine & Iraksin 5 microgram mhraproducts4853.blob.core....

🟣 SPC Morningside Liothyronine & Iraksin 10 microgram mhraproducts4853.blob.core....

🟣 SPC Morningside Liothyronine & Iraksin 20 microgram mhraproducts4853.blob.core....

—————————————————————

🔹 Teva – (marketing authorisation holder)

🏭 TEVA Gyógyszergyár Zrt. in Hungary (manufacturer)

No lactose ingredient

  20 microgram  PL 00289/2116

🟢 PIL mhraproducts4853.blob.core....

🟣 SPC mhraproducts4853.blob.core....

➖➖➖➖➖➖➖➖➖➖➖➖➖➖

Some non-UK Liothyronine Tablets

—————————————————————

🔹 Abdi Ibrahim (marketing authorisation holders – Turkey) – branded Tiromel

🏭 Abdi Ibrahim, Turkey (manufacturer)

🥛 contains lactose

  25 microgram  

—————————————————————

🔹 Ace (marketing authorisation holder – Netherlands) – branded Cytomel

🏭 Ace (manufacturer)

  5 microgram  

  12.5 microgram  

  25 microgram  

—————————————————————

🔹 Greenstone (marketing authorisation holder – USA) – branded Greenstone

🏭 Peptido GmbH in Germany (manufacturer)

No lactose ingredient

  5 microgram  NDC 59762-1206-1

  25 microgram  NDC 59762-1207-1

  50 microgram  NDC 59762-1208-1

🟢🟣 dailymed.nlm.nih.gov/dailym...

—————————————————————

🔹 Grossman Cynomel (marketing authorisation holder – Mexico)

🏭 Grossman subsidiary of Bausch (formerly Valeant) in Mexico (manufacturer)

  25 microgram  

—————————————————————

🔹 IBSA oral solution (marketing authorisation holder – Italy) – branded Liotir

🏭 IBSA Farmaceutici Italia S.r.l in Italy (manufacturer)

No lactose ingredient

  5 microgrammi/ml

  10 microgrammi/ml

  15 microgrammi/ml

  20 microgrammi/ml

🟢 PIL – farmaci.agenziafarmaco.gov....

—————————————————————

🔹 Mayne Pharma (marketing authorisation holder – USA) – branded Mayne Pharma (formerly Libertas, Perrigo and Paddock)

🏭 manufactured in Germany (manufacturer)

No lactose ingredient

  5 microgram   NDC 51862-320-01

  25 microgram  NDC 51862-321-01

  50 microgram  NDC 51862-322-01

🟢🟣 dailymed.nlm.nih.gov/dailym...

—————————————————————

🔹 Pfizer (marketing authorisation holder – USA) – branded Cytomel

🏭 Peptido GmbH manufactured in Austria and/or Germany

No lactose ingredient

  5 microgram  NDC 60793-115-01

  25 microgram  NDC 60793-116-01

  50 microgram  NDC 60793-117-01

🟢🟣 dailymed.nlm.nih.gov/dailym...

—————————————————————

🔹 Sanofi (marketing authorisation holder – France) – branded Cynomel

🏭 PATHEON FRANCE in France (manufacturer)

No lactose ingredient

  25 microgram  ANSM 34009 302 775 5 3

🟢 PIL (French) base-donnees-publique.medic...

🟣 SPC base-donnees-publique.medic...

—————————————————————

🔹 Sanofi Deutschland (marketing authorisation holder – Germany) – branded Henning Thybon

🏭 Sanofi-Aventb, Barcelona, Spain (manufacturer)

No lactose ingredient

  20 microgram   ZN 6085344.00.00

  100 microgram   ZN 6085344.01.00

🟢 PIL 20 (German) mein.sanofi.de/produkte/Thy...

🟢 PIL 20 (English translation – out of date) dropbox.com/s/ccfr0tnmr7nom...

🟢 PIL 100 (German) mein.sanofi.de/produkte/Thy...

🟣 SPC 20 & 100 (German) mein.sanofi.de/produkte/Thy...

—————————————————————

🔹 SigmaPharm (marketing authorisation holder – USA)

🏭 Sigmapharm Laboratories, LLC in USA (manufacturer)

No lactose ingredient

  5 microgram  NDC 42794-018-12

  25 microgram  NDC 42794-019-12

  50 microgram  NDC 42794-020-12

🟢🟣 dailymed.nlm.nih.gov/dailym...

—————————————————————

🔹 Sun Pharmaceutical Industries (marketing authorisation holder – USA)

🏭 Sun Pharmaceutical Industries Limited in USA (manufacturer)

No lactose ingredient

  5 microgram  NDC:62756-589-83, NDC:62756-589-88, NDC:62756-589-08, NDC:62756-589-18

  25 microgram  NDC:62756-590-83, NDC:62756-590-88, NDC:62756-590-08, NDC:62756-590-18

  50 microgram  NDC:62756-591-83, NDC:62756-591-88, NDC:62756-591-08, NDC:62756-591-18

🟢🟣 dailymed.nlm.nih.gov/dailym...

—————————————————————

🔹 Uni-Pharma (marketing authorisation holder – Greece)

🏭 Uni-Pharma in Greece (manufacturer)

  25 microgram  

🟢🟣

➖➖➖➖➖➖➖➖➖➖➖➖➖➖

🔹 – identifies marketing authorisation holder (or equivalent in other countries)

🔸 – identifies ‘own label supplier’ products

🏭 – identifies manufacturers (where known)

🥛 – contains lactose

🟢 PIL – Patient Information Leaflet

🟣 SPC – Summary of Product Characteristics document

🟢🟣 – Single document combining typical PIL and SPC information

—————————————————————

Numbers refer to tablet dosages in micrograms.

Only products which definitely contain lactose are identified (🥛 contains lactose). Please always check other products. Where products are ‘own label supplier’, check the marketing authorisation holder for the specific product.

If there is anything inaccurate in this information, please let me know by Private Message, or on the forum:

healthunlocked.com/user/hel...

➖➖➖➖➖➖➖➖➖➖➖➖➖➖

This document is updated whenever I am aware of any changes or enhancements are needed. Please check the Last updated date. The current version is available as a PDF here:

dropbox.com/s/xlibro9l9jbfb...

The PDF version of this document has a QR code above this sentence. If your device has a camera and can interpret QR codes, this QR code should take you to the same place as the link and make it easier to download on devices, such as phones and tablets.

jimh111
jimh111 in reply to jimh111

Tertroxin was the brand name in the UK and still is in countries such as Australia. I don't know when the patent expired but it was a long time ago. Licence holders can decide whether to continue using the brand name or go generic. Usually they keep brand names so they can sell at a premium but by debranding Tertroxin they were able to escape price regulation and use their monopoly position to extort high prices.

Once a high price has been achieved other companies will come along with their generic versions but will be reluctant to rock the boat and get into a price war. Better they each take a share of a 20,000% profit margin that fight for an increased share with a 20% margin.

paradime
paradime in reply to jimh111

Thanks. I thought the patent must have lapsed a long time ago. I don't understand how the price got hiked from 2007 (or before) if there were multiple licence holders then. Are we suggesting a de-facto cartel. Perhaps I am naive but I thought competition was supposed too prevent profiteering and generic meds were supposed to be cheap.

jimh111
jimh111 in reply to paradime

At that time and for many years there was only one UK licence holder - Goldshield. They debranded Tertroxin and increased the price. The licence was then sold on a number of times with each holder increasing the price.

When there are massive margins it's not in a companies interest to try and undercut its competitors. If they start a price war their margins will be small (i.e. reasonable). If they charge close to the existing price they can make a lot of money, they have a small piece of a gigantic pie rather than a big piece of a small pie. No need for cartels, just do nothing to rock the gravy train.

paradime
paradime in reply to jimh111

I think that's what I meant by a de-facto cartel. They may not be communicating directly with each other but by refraining from severe price competition....riding the gravy train, whilst not rocking the gravy boat.

However, if most CCGs will not stand for even the new prices it is indeed a small pie.

How do EU rules, affect this? Free markets and all that guff, he asked, expecting the answer, not at all!

SlowDragon
SlowDragonAdministrator in reply to paradime

There was conscious decision by certain companies to buy “out of patent” single license medications.

It seems any medication out of patent, could be reclassified as a generic and therefore no price control mechanism in place

This loophole blocked in 2016,

pharmaphorum.com/views-and-...

but no easy routine way to force the prices down. Government does have power to enforce price reduction but not ever been used

paradime
paradime in reply to SlowDragon

Great link, many thanks. It was April 2017 in the pre-election wash-up. So, not so long ago. How long do such Acts take to roll out? In parliamentary/civil service terms, is this still seriously early days, or have lobbyists "brown-enveloped" this into oblivion already?

I am a very optimistic cynic, and a very cynical optimist.

helvella
helvellaAdministrator

I do not believe that liothyronine was ever patented in the UK or the USA.

I'd be very interested if anyone could show that it was patented. Anywhere. Ever. Not just the UK and USA.

The UK liothyronine product was not re-branded but de-branded.

jimh111

jimh111
jimh111 in reply to helvella

I don't know anything about any patent, just know Goldshield debranded Tertroxin to avoid price regulation.

Thanks, possibly a false assumption on my part that it would have had a patent when first developed, licenced. I think my real Q was why the price hiking from about 2007 if as I now understand it is licenced to several producers. Now I am told prices have fallen back but are still extortionate. Should I expect better or plan a trip to Greece?

helvella
helvellaAdministrator in reply to paradime

The price was raised because the company saw an opportunity to gouge the NHS (hence, us).

First, de-brand. Then raise the price because generic medicines do not have the same price controls as branded. The assumption is that if a medicine price is too high, another company will launch products to compete.

However, that requires another company to see some profit potential. At a price of something like £12 for 28 tablets, likely no-one else would have bothered. The fairly low level of sales would also not be that appealing.

Advanz Pharma seemed to have some quality control issues, as well. The MHRA were demanding samples of every batch. They claimed that they were charging so much in order to fund a new factory. Completely ignoring the fact that it is manufactured by another company. And we don't usually pay factory investment costs ahead of the product being supplied.

When Advanz raised the price sufficiently, two other companies eventually decided to launch products. Teva and Morningside chose not to compete on price.

paradime
paradime in reply to helvella

Interesting, I was informed that NHS wanted better quality and perhaps more tab sizes, hence a sole-supplier contract for Concordia/Advanz. Seems I might have cart before horse. Now I am seeing Advanz/Mercury only supply 20 mcg. Have I got that much right?

helvella
helvellaAdministrator in reply to paradime

I am unaware of there being - now or ever - a sole-supplier contract for liothyronine.

The MHRA was, clearly, unhappy with the quality control. Advanz blamed the factory.

That was why every batch had to be passed by the MHRA.

I have already listed every UK liothyronine tablet, including the Product Licence numbers, in this thread.

But so far as I am aware, and not being in the medical industry I have to base things on what I can find, any other pharmaceutical company could have put in a licence application. The forms to apply can be downloaded from the MHRA part of the government website.

SlowDragon
SlowDragonAdministrator in reply to paradime

As one of the leading UK endocrinologists wryly suggested......it was perhaps the scale of profits being made that enticed two new license applications.

ft.com/content/5ba9dafe-12f...

RedApple
RedAppleAdministrator

paradime, 'Should I expect better or plan a trip to Greece?'

This issue has been going on for years, so probably best not to hold your breath for a significant price drop any time soon. A trip to Greece may not be productive either, because liothyronine is not nearly as readily available off prescription there as it once was.

paradime
paradime in reply to RedApple

Yes, I know it has been years, and the Lords debated it in 2018, and the Competition and Monopolies Authority are supposed to have been involved and NHS are supposed to have been claiming back "overpayments". Meanwhile my CCG won't cough up (perhaps I should mail them an emetic).

Still dazed and confused and trying to see the wood for the trees, and fake news from fact.

This site is very useful if only for busting some myths. I take the point about Greece and will have to consider a private prescription.

paradime
paradime in reply to paradime

Sorry , Competition and Markets Authority and that was 2017. Senior moment, or was it simply lack of L-T3?

magsyh
magsyh in reply to RedApple

It is still easily found in Turkey for less than £3 for 100.

Gingernut44
Gingernut44 in reply to magsyh

Perhaps we should charter a plane and go en masse to Turkey and stock up 😊

You may also like...