FDA Orange Book
Is there a generic for Tukysa?
Tukysa contains tucatinib. 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 Tukysa (tucatinib). The Orange Book shows its last listed patent expires April 27, 2038 and its last listed exclusivity ends January 19, 2030.
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Tukysa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 150MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 50MG | Marketed (Rx) | None | 0 | None |
NDA 213411, held by SEAGEN INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tukysa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9693989 | May 9, 2027 | Drug product | U-2788 | 213411 |
| 9457093 | October 12, 2032 | Drug product | U-2788 | 213411 |
| 11504370 | March 25, 2033 | Method of use | U-2788 | 213411 |
| 8648087 | April 17, 2034 | Drug substance, Drug product | None | 213411 |
| 11666572 | April 27, 2038 | Method of use | U-3783 | 213411 |
| 12048698 | April 27, 2038 | Method of use | U-3783 | 213411 |
| 11207324 | April 27, 2038 | Method of use | U-3783 | 213411 |
Tukysa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-906 | New indication | January 19, 2026 | 213411 |
| ODE-309 | Orphan drug exclusivity | April 17, 2027 | 213411 |
| ODE-422 | Orphan drug exclusivity | January 19, 2030 | 213411 |
Tukysa NDC codes
Questions
Is there a generic for Tukysa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tukysa (tucatinib). The Orange Book shows its last listed patent expires April 27, 2038 and its last listed exclusivity ends January 19, 2030.
What is the generic name for Tukysa?
The active ingredient in Tukysa is tucatinib, per the FDA Orange Book.
When does the Tukysa patent expire?
The last patent listed for Tukysa in the Orange Book expires April 27, 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.