TRULICITY biosimilars — when can they launch?
TRULICITY (DULAGLUTIDE) · BLA125469 · ELI LILLY AND CO
Where TRULICITY sits in the biosimilar timeline
BPCIA reference product exclusivity for TRULICITY expired in 2026. Biosimilars are eligible for FDA 351(k) approval in the US. Active biosimilar applications and approvals will appear here as they're filed.
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 TRULICITY
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by ELI LILLY AND CO) | 2014-09-18 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2018-09-18 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2026-09-18 | Past |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See TRULICITY on Drug Landscape for the full patent picture.
Other ELI LILLY AND CO biologics
- CYRAMZA — exclusivity to 2026-04-21
- HUMALOG KWIKPEN — exclusivity to 2027-05-26
- BASAGLAR KWIKPEN — exclusivity to 2027-12-16
- TALTZ — exclusivity to 2028-03-22
- EMGALITY — exclusivity to 2030-09-27
- LYUMJEV — exclusivity to 2032-06-15
- OMVOH — exclusivity to 2035-10-26
- EBGLYSS — exclusivity to 2036-09-13
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- TRULICITY drug profile — full patent estate, indications, clinical trials
- ELI LILLY AND CO 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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