FDA Orange Book
Is there a generic for Turalio?
Turalio contains pexidartinib. 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 Turalio (pexidartinib). The Orange Book shows its last listed patent expires July 24, 2038 and its last listed exclusivity ends August 2, 2026.
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Turalio products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 125MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 200MG BASE | Discontinued | None | 0 | None |
NDA 211810, held by DAIICHI SANKYO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Turalio patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8404700 | November 21, 2027 | Drug substance | None | 211810 |
| 8722702 | November 21, 2027 | Drug substance | None | 211810 |
| 9169250 | November 21, 2027 | Drug substance | None | 211810 |
| 8461169 | April 19, 2028 | Method of use | U-2606 | 211810 |
| 7893075 | May 4, 2033 | Drug substance | None | 211810 |
| 9358235 | June 8, 2033 | Method of use | U-2606 | 211810 |
| 10189833 | May 5, 2036 | Method of use | U-2606 | 211810 |
| 10730876 | May 5, 2036 | Drug substance | None | 211810 |
| 9802932 | May 5, 2036 | Drug substance | None | 211810 |
| 10961240 | July 24, 2038 | Method of use | U-2606 | 211810 |
| 10941142 | July 24, 2038 | Drug product | None | 211810 |
| 10435404 | July 24, 2038 | Drug product | None | 211810 |
Turalio exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE* | See the Orange Book exclusivity code list | August 2, 2026 | 211810 |
| ODE-250 | Orphan drug exclusivity | August 2, 2026 | 211810 |
Turalio NDC codes
Questions
Is there a generic for Turalio?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Turalio (pexidartinib). The Orange Book shows its last listed patent expires July 24, 2038 and its last listed exclusivity ends August 2, 2026.
What is the generic name for Turalio?
The active ingredient in Turalio is pexidartinib, per the FDA Orange Book.
When does the Turalio patent expire?
The last patent listed for Turalio in the Orange Book expires July 24, 2038. 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.