FDA Orange Book
Is there a generic for Ibtrozi?
Ibtrozi contains taletrectinib adipate. 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 Ibtrozi (taletrectinib adipate). The Orange Book shows its last listed patent expires June 3, 2033 and its last listed exclusivity ends June 11, 2032.
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Ibtrozi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 219713, held by NUVATION BIO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ibtrozi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9751887 | June 3, 2033 | Drug substance, Drug product | U-4207 | 219713 |
| 9187489 | June 3, 2033 | Drug substance, Drug product | U-4207 | 219713 |
Ibtrozi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 11, 2030 | 219713 |
| ODE-544 | Orphan drug exclusivity | June 11, 2032 | 219713 |
Ibtrozi NDC codes
Questions
Is there a generic for Ibtrozi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ibtrozi (taletrectinib adipate). The Orange Book shows its last listed patent expires June 3, 2033 and its last listed exclusivity ends June 11, 2032.
What is the generic name for Ibtrozi?
The active ingredient in Ibtrozi is taletrectinib adipate, per the FDA Orange Book.
When does the Ibtrozi patent expire?
The last patent listed for Ibtrozi in the Orange Book expires June 3, 2033. 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.