TYRUKO biosimilars — when can they launch?
TYRUKO (NATALIZUMAB-SZTN) · BLA761322 · SANDOZ INC
Where TYRUKO sits in the biosimilar timeline
BPCIA 12-year reference product exclusivity for TYRUKO extends to 2035 (9 years from today). Biosimilars cannot be approved by the FDA before this date. Biosimilar developers begin clinical comparability studies 4-6 years before the cliff.
Under the US Biologics Price Competition and Innovation Act (BPCIA), a reference biologic is protected from biosimilar competition for 12 years from FDA approval (with 4 years of data exclusivity preventing 351(k) submissions). Biosimilars enter via the abbreviated 351(k) pathway, which requires comparability — not exact identity — to the reference product.
Key dates for TYRUKO
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by SANDOZ INC) | 2023-08-24 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2027-08-24 | Future |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2035-08-24 | Future |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See TYRUKO on Drug Landscape for the full patent picture.
Other SANDOZ INC biologics
- ZARXIO — exclusivity to 2027-03-06
- ADALIMUMAB — exclusivity to 2030-10-30
- ZIEXTENZO — exclusivity to 2031-11-04
- CIMERLI — exclusivity to 2034-08-02
- WYOST — exclusivity to 2036-03-05
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- TYRUKO drug profile — full patent estate, indications, clinical trials
- SANDOZ INC patent portfolio
Not legal advice. BPCIA exclusivity may interact with composition-of-matter patents and patent term extensions — see the full drug profile for the consolidated picture.
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