LEVEMIR biosimilars — when can they launch?
LEVEMIR (INSULIN DETEMIR) · BLA021536 · NOVO NORDISK INC
Where LEVEMIR sits in the biosimilar timeline
BPCIA reference product exclusivity for LEVEMIR expired in 2017. 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 LEVEMIR
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by NOVO NORDISK INC) | 2005-06-16 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2009-06-16 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2017-06-16 | Past |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See LEVEMIR on Drug Landscape for the full patent picture.
Other NOVO NORDISK INC biologics
- NOVOLIN R — exclusivity to 2003-06-25
- NOVOLIN 70/30 — exclusivity to 2003-06-25
- NOVOLIN N — exclusivity to 2003-07-01
- NOVOLOG — exclusivity to 2012-06-07
- NORDITROPIN — exclusivity to 2012-06-20
- INSULIN ASPART PROTAMINE AND INSULIN ASPART MIX 70/30 — exclusivity to 2013-11-01
- SOGROYA — exclusivity to 2032-08-28
- ALHEMO — exclusivity to 2036-12-20
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- LEVEMIR drug profile — full patent estate, indications, clinical trials
- NOVO NORDISK 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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