CHORIONIC GONADOTROPIN biosimilars — when can they launch?
CHORIONIC GONADOTROPIN (Chorionic Gonadotropin) · BLA017067 · FRESENIUS KABI USA
Where CHORIONIC GONADOTROPIN sits in the biosimilar timeline
BPCIA reference product exclusivity for CHORIONIC GONADOTROPIN expired in 1985. 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 CHORIONIC GONADOTROPIN
| Event | Date | Status |
|---|---|---|
| FDA approval (BLA filed by FRESENIUS KABI USA) | 1973-03-05 | Past |
| 4-year data exclusivity ends (first biosimilar 351(k) submission permitted) | 1977-03-05 | Past |
| 12-year reference product exclusivity ends (first biosimilar can be marketed) | 1985-03-05 | Past |
Note: composition-of-matter and method-of-use patent expiries (separate from BPCIA exclusivity) may set the actual launch window. See CHORIONIC GONADOTROPIN on Drug Landscape for the full patent picture.
Other FRESENIUS KABI USA biologics
Sources
- FDA Purple Book — biologic license applications + BPCIA exclusivity
- CHORIONIC GONADOTROPIN drug profile — full patent estate, indications, clinical trials
- FRESENIUS KABI USA 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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