FDA Orange Book
Is there a generic for Ojemda?
Ojemda contains tovorafenib. 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 Ojemda (tovorafenib). The Orange Book shows its last listed patent expires June 23, 2035 and its last listed exclusivity ends April 23, 2031.
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Ojemda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 25MG/ML | Marketed (Rx) | None | 0 | None |
| tablet, oral | 100MG | Marketed (Rx) | None | 0 | None |
NDA 218033, 217700, held by DAY ONE BIOPHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ojemda patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8293752 | August 4, 2031 | Drug substance, Drug product | None | 218033 |
| 10426782 | June 23, 2035 | Drug product | None | 218033 |
Ojemda exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 23, 2029 | 218033 |
| ODE-478 | Orphan drug exclusivity | April 23, 2031 | 218033 |
Ojemda NDC codes
Questions
Is there a generic for Ojemda?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ojemda (tovorafenib). The Orange Book shows its last listed patent expires June 23, 2035 and its last listed exclusivity ends April 23, 2031.
What is the generic name for Ojemda?
The active ingredient in Ojemda is tovorafenib, per the FDA Orange Book.
When does the Ojemda patent expire?
The last patent listed for Ojemda in the Orange Book expires June 23, 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.