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About generics in UK

hello david and other uk memebers. are spyrel and nilotinib is available as generics in uk and much it costs as compared to india.

As far as I know, nilotinib (Tasigna) will be out of patent by mid 2023, for dasatinib (Sprycel) the US patent is expected to expire in October 2025. Neither are available as generic in the UK.

I think there is a generic available in India, following the expiry of the Indian patent in April 2020

Richard is an expert in patent law etc and may well answer this question better than I can.

Hi!

I would just add that to the best of my knowledge, dasatinib will be off patent in the European Union mid 2022. The European Medicines Agencys medicines registry is already filled by dasatinib generics marketing authorisations (Sandoz, Teva, Accord etc).

Timo

Dasatinib is available as a generic in the UK and a number of CML patients have received it in error. It is presently approved for ALL but not CML.

See https://bnf.nice.org.uk/medicinal-forms/dasatinib.html for prices of Zentiva Pharma.

The position is a bit complicated.  There are no less than 5 marketing authorisations for generic dasatinib in the UK, three of which include CML as an indication (Teva, Tiefenbacher and Thornton & Ross (Stada)). The other two, which are ALL only, are Tillomed and Zentiva. 
 

However, dasatinib has had a mixed time patent wise in Europe, with the master patent perhaps controversially invalidated some time ago.  There is however also a patent covering use of dasatinib in CML specifically.  From what I can see, this was recently upheld in the European Patent Office (nothing to do with the EU by the way), so remains in force until March 2024. That would explain why no generics are actually on the market in the UK yet for CML even if there is marketing approval. It is not impossible that one or more may challenge the patent in the UK specifically (it happens and legal decisions here often differ from those in Europe)  but I can’t find any sign of that happening yet.

I’ve not checked the detailed position for nilotinib but you can rest assured that for all the TKIs, as soon as the patent and regulatory position allows (and big generics are very proactive on this sort of thing, challenging patents that block their way when they can), there will be generics for all of them.  

Richard

And that folks is why Richard who understands patents is so valuable to the forum.

Thanks Richard

Alastair

I absolutely agree with you Alastair, my thoughts precisely.

Thank You Richard.

pigeon.

Hello Richard,

Can you please share more details. I live in the UK, use the SPRYCEL the last 3 years and I was offered the TEVA this time.

Thanks in advance.

regards
Lampros

Hi,

Richard will know more about this than me, but you can see here that the PIL (Patient Information Leaflet) is very clear that Teva dasatinib is indicated for CML.

https://www.medicines.org.uk/emc/product/14269/pil

There had been another manufacturer (Zentiva) who only had authorisation to market for PH+ ALL, even though it is exactly the same drug. Even then, I believe that’s been updated to include CML too.

David.

Apologies for somewhat belated response - am prompted to reply by discussions on another forum about whether generic dasatinib should or should not be available in the UK for CML. My understanding is that yes, it is now available and fully licensed (previously some pharmacists had been fulfilling dasatinib prescriptions with generics when they were only formally authorised for Ph+ CLL.

When I looked at this a few years ago, i noted that some dasatinib generics had been authorised for both CML and CLL but those typically reaching patients (Zentiva) were not. I'm guessing but I think Teva may not have made its product available until comparatively recently. However, as David points out that position has changed. This seems to have happened in the last year to 18 months, before the patent covering dasatinib for CML expired (due next year). However, as generics are generally cautious they don't (generally) seek authorisation for a patented indication until it is clear they have little or no risk. The patent position for dasatinib has been somewhat murky but the fact that both Teva and Zentiva are now expressly including CML in their PILs and their products are being widely used in CML tells me that at least as between the companies concerned, the issue is settled. I don't know that for a fact and can't find anything publicly available to confirm it but my experience tells me that's what has happened.

You may see that information on eg Leukaemia Care's website about generic dasatinib in the UK suggests otherwise but that was written several years ago and seems to me to be out of date. The long and the short of it therefore seems to be that generic dasatinib is clearly available for use in CML in the UK now, and as others have posted hospitals are increasingly switching.

As with other generics, obviously let your doctor know about any new side effects. As the active ingredient is the same and has to be delivered in the same way (bioequivalent), there should not be any different side effects associated with the active. Some people report changes with imatinib generics. I had fairly significant gastro intestinal and nausea issues with Glivec itself, which i attributed to the formulation not the drug itself, so it's possible to see differences there. However, generally it is my understanding that the dasatinib generics do not produce similar changes in side effects, which may be something to do with how it has to be formulated.

We will see other TKIs go generic in due course and there will be switches.

Thank you, Richard. Having suffered considerable adverse effects from generic imatinib, I dreaded generic dasatinib. However, Teva dasatinib has given me no issues whatsoever.