About tezacaftor
Tezacaftor manufacturers are limited to the originator, Vertex Pharmaceuticals, which uses it in three cystic fibrosis combinations: Symdeko (Symkevi in the EU), Trikafta (Kaftrio in the EU) and Alyftrek. Tezacaftor is a CFTR corrector that helps the defective CFTR protein fold correctly and reach the cell surface. It is not sold on its own. No generic is approved in the US or EU. Companies interested in tezacaftor can explore future generic development as patents expire.
Tezacaftor key facts
|
Property |
Tezacaftor |
|---|---|
|
INN |
Tezacaftor |
|
Molecular formula / weight |
C26H27F3N2O6 / 520.5 g/mol |
|
Drug class |
CFTR corrector |
|
Products containing tezacaftor |
Symdeko / Symkevi (with ivacaftor); Trikafta / Kaftrio (with elexacaftor and ivacaftor); Alyftrek (with vanzacaftor and deutivacaftor) |
|
Originator |
Vertex Pharmaceuticals |
|
Dosage form |
Fixed-dose combination tablets and granules; not available alone |
|
Indication |
Cystic fibrosis in patients with responsive CFTR mutations |
|
First approval |
Symdeko, US FDA, February 2018 |
|
Trikafta approval |
US FDA, October 2019; EU (Kaftrio), 2020 |
|
Alyftrek approval |
US FDA, December 2024; EU, July 2025 |
|
Patent status |
Trikafta protected to 2037; Alyftrek to 2039 (analyst estimates) |
|
Generic status |
None approved in the US or EU |
Tezacaftor manufacturers and licensing history
Vertex developed tezacaftor as a second-generation CFTR corrector. It was first approved in February 2018 in Symdeko, combined with the potentiator ivacaftor. In October 2019, it became part of Trikafta, Vertex's triple combination with elexacaftor and ivacaftor, which transformed cystic fibrosis treatment for most patients.
In December 2024, the FDA approved Alyftrek, a once-daily triple combination of vanzacaftor, tezacaftor and deutivacaftor. The EU approved it in July 2025 for patients aged 6 and over with at least one non-class I CFTR mutation. Alyftrek is designed to replace Trikafta over time and extends Vertex's patent protection.
No generic tezacaftor product is approved in the US or EU. Generic developers would need to match complex fixed-dose combinations and wait for patent expiry.
Tezacaftor dosage forms and dossier types
Tezacaftor is available only in fixed-dose combination tablets and granules.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Tezacaftor / ivacaftor tablets |
E.g. 100/150 mg |
Originator only |
Symdeko / Symkevi |
|
Elexacaftor / tezacaftor / ivacaftor tablets |
E.g. 100/50/75 mg |
Originator only |
Trikafta / Kaftrio |
|
Vanzacaftor / tezacaftor / deutivacaftor tablets |
Per label |
Originator only |
Alyftrek; once daily |
|
Tezacaftor API |
Bulk |
Future DMF |
For generic development |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
United States |
Future ANDA |
Patents to 2037 (Trikafta) and 2039 (Alyftrek) |
|
European Union |
Future EU CTD |
Data protection and SPC expiry |
|
Other markets |
National CTD |
Check local patents and access programmes |
Tezacaftor regulatory and patent status
Tezacaftor was first approved in Symdeko in February 2018, then in Trikafta in October 2019 and Alyftrek in December 2024 (US) and July 2025 (EU). Analysts estimate Trikafta's protection to run to 2037 and Alyftrek's to 2039. No generic is approved in the US or EU, so check patent and exclusivity status before any development.
Tezacaftor mechanism of action and therapeutic use
In cystic fibrosis, mutations in the CFTR gene cause the CFTR protein to misfold and fail to reach the cell surface. Tezacaftor is a corrector that helps the protein fold and move to the surface. It is combined with a potentiator, such as ivacaftor or deutivacaftor, which helps the channel open. Tezacaftor combinations are used for cystic fibrosis in patients with responsive mutations.
Tezacaftor licensing and sourcing
Tezacaftor is currently available only from Vertex, in combination products. Companies interested in this molecule usually prepare future generic dossiers or API supply. Current offers and contacts are listed among the tezacaftor manufacturers on Pipelinepharma.
Frequently asked questions about tezacaftor
Who manufactures tezacaftor? Vertex Pharmaceuticals is the only manufacturer and uses tezacaftor in Symdeko, Trikafta and Alyftrek.
Is tezacaftor available on its own? No. Tezacaftor is sold only in fixed-dose combinations with other CFTR modulators.
Is there a generic version of tezacaftor? No. No generic tezacaftor product is approved in the US or EU, and patents are in force.
What is tezacaftor used for? Tezacaftor is used in combinations to treat cystic fibrosis in patients with responsive CFTR mutations.
What is the difference between Trikafta and Alyftrek? Both contain tezacaftor. Trikafta also contains elexacaftor and ivacaftor and is taken twice daily. Alyftrek contains vanzacaftor and deutivacaftor and is taken once daily.
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