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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.


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).


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 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.  


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

Thanks Richard


I absolutely agree with you Alastair, my thoughts precisely.

Thank You Richard.