FDA Orange Book
Is there a generic for Lytgobi?
Lytgobi contains futibatinib. 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 Lytgobi (futibatinib). The Orange Book shows its last listed patent expires November 5, 2039 and its last listed exclusivity ends September 30, 2029.
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Lytgobi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 16MG | Discontinued | None | 0 | None |
| tablet, oral | 4MG | Marketed (Rx) | None | 0 | None |
NDA 214801, held by TAIHO ONCOLOGY INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Lytgobi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9108973 | February 13, 2033 | Drug substance, Drug product | U-3456 | 214801 |
| 10434103 | March 31, 2036 | Drug substance, Drug product | None | 214801 |
| 11833151 | November 5, 2039 | Drug product | None | 214801 |
Lytgobi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 30, 2027 | 214801 |
| ODE-410 | Orphan drug exclusivity | September 30, 2029 | 214801 |
| ODE* | See the Orange Book exclusivity code list | September 30, 2029 | 214801 |
Lytgobi NDC codes
Questions
Is there a generic for Lytgobi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Lytgobi (futibatinib). The Orange Book shows its last listed patent expires November 5, 2039 and its last listed exclusivity ends September 30, 2029.
What is the generic name for Lytgobi?
The active ingredient in Lytgobi is futibatinib, per the FDA Orange Book.
When does the Lytgobi patent expire?
The last patent listed for Lytgobi in the Orange Book expires November 5, 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.