Tolebrutinib Tablets 60 mg Suppliers & Bulk Manufacturers

Available Forms: Film-coated tablets

Available Strengths: 60 mg

Reference Brands: Cenrifki

Category: Neurology

Tolebrutinib (Cenrifki, Sanofi) is a brain-penetrant BTK inhibitor tablet for non-relapsing secondary progressive multiple sclerosis. It is approved in the EU (June 2026) and the UAE, but the US FDA declined it in December 2025. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers, API makers and licensees preparing for patent expiry.

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Product Description:

Tolebrutinib blocks Bruton's tyrosine kinase (BTK), an enzyme in B cells and in microglia, the immune cells of the brain. Because it crosses into the brain, it is aimed at the slow, smouldering inflammation behind disability progression in multiple sclerosis, which most existing MS medicines do not reach well. It is taken as a 60 mg tablet once a day.

Tolebrutinib is approved in the European Union (June 2026) for non-relapsing secondary progressive MS, a stage with very few treatment options, and it received provisional approval in the UAE in 2025. The US FDA declined to approve it in December 2025. Liver injury was seen in trials, so liver tests are monitored during treatment.

Sourcing and licensing notes. Tolebrutinib is patented and made only by Sanofi; there is no generic. Its approval status differs by region, so we confirm the position for each destination before quoting. We handle enquiries for authorised supply of Cenrifki and connect developers and licensees interested in BTK inhibitors for MS ahead of patent expiry.

How Tolebrutinib Tablets is supplied today, and licensing ahead of patent expiry

Tolebrutinib Tablets is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Tolebrutinib Tablets, hold a dossier for it or want to license it, talk to us.

Where tolebrutinib is approved

Checked 3 Oct 2026

Market	Status	Brand · regulator · date
United Arab Emirates	Approved	Cenrifki · provisional approval · Jul 2025
European Union	Approved	Cenrifki · European Commission · Jun 2026
United States	Not approved	FDA declined to approve it, Dec 2025
Generic / biosimilar	None	None approved as of the check date

Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

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