NOVOLOG biosimilars — when can they launch?
NOVOLOG (INSULIN ASPART) · BLA020986 · NOVO NORDISK INC
Where NOVOLOG sits in the biosimilar timeline
BPCIA reference product exclusivity for NOVOLOG expired in 2012. 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 NOVOLOG
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by NOVO NORDISK INC) | 2000-06-07 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 2004-06-07 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 2012-06-07 | Past |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See NOVOLOG 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
- NORDITROPIN — exclusivity to 2012-06-20
- LEVEMIR — exclusivity to 2017-06-16
- SOGROYA — exclusivity to 2032-08-28
- ALHEMO — exclusivity to 2036-12-20
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- NOVOLOG 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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