FDA Orange Book
Is there a generic for Inrebic?
Inrebic contains fedratinib. 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 Inrebic (fedratinib). The Orange Book shows its last listed patent expires September 24, 2039 and its last listed exclusivity ends August 16, 2026.
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Inrebic products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
NDA 212327, held by BRISTOL-MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Inrebic patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7825246 | December 16, 2026 | Drug substance | None | 212327 |
| 8138199 | June 30, 2028 | Method of use | U-2607 | 212327 |
| 7528143 | November 16, 2031 | Drug substance, Drug product | None | 212327 |
| 10391094 | June 4, 2032 | Drug product | U-2607 | 212327 |
| 11400092 | September 24, 2039 | Method of use | U-3409 | 212327 |
Inrebic exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-259 | Orphan drug exclusivity | August 16, 2026 | 212327 |
Inrebic NDC codes
Questions
Is there a generic for Inrebic?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Inrebic (fedratinib). The Orange Book shows its last listed patent expires September 24, 2039 and its last listed exclusivity ends August 16, 2026.
What is the generic name for Inrebic?
The active ingredient in Inrebic is fedratinib, per the FDA Orange Book.
When does the Inrebic patent expire?
The last patent listed for Inrebic in the Orange Book expires September 24, 2039. 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.