FDA Orange Book
Is there a generic for Fetroja?
Fetroja contains cefiderocol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Fetroja (cefiderocol). The Orange Book shows its last listed patent expires September 3, 2035 and its last listed exclusivity ends November 14, 2029.
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Fetroja products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 1GM BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 209445, held by SHIONOGI INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Fetroja patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9238657 | November 14, 2033 | Drug substance, Drug product | U-282 | 209445 |
| 9238657 | November 14, 2033 | Drug substance, Drug product | U-3470 | 209445 |
| 9238657 | November 14, 2033 | Drug substance, Drug product | U-3471 | 209445 |
| 10004750 | September 3, 2035 | Drug substance, Drug product | None | 209445 |
| 9949982 | September 3, 2035 | Drug product | None | 209445 |
Fetroja exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 14, 2024 | 209445 |
| GAIN | Generating Antibiotic Incentives Now | November 14, 2029 | 209445 |
Fetroja NDC codes
Questions
Is there a generic for Fetroja?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Fetroja (cefiderocol). The Orange Book shows its last listed patent expires September 3, 2035 and its last listed exclusivity ends November 14, 2029.
What is the generic name for Fetroja?
The active ingredient in Fetroja is cefiderocol, per the FDA Orange Book.
When does the Fetroja patent expire?
The last patent listed for Fetroja in the Orange Book expires September 3, 2035. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.