FDA Orange Book
Is there a generic for Alunbrig?
Alunbrig contains brigatinib. 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 Alunbrig (brigatinib). The Orange Book shows its last listed patent expires November 10, 2035 and its last listed exclusivity ends May 22, 2027.
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Alunbrig products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 180MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 30MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 90MG | Marketed (Rx) | None | 0 | None |
NDA 208772, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Alunbrig patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9273077 | May 21, 2029 | Method of use | U-2837 | 208772 |
| 9012462 | April 28, 2031 | Drug substance | None | 208772 |
| 9611283 | April 10, 2034 | Method of use | U-2837 | 208772 |
| 10385078 | November 10, 2035 | Drug substance, Drug product | U-2837 | 208772 |
Alunbrig exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-300 | Orphan drug exclusivity | May 22, 2027 | 208772 |
Alunbrig NDC codes
Questions
Is there a generic for Alunbrig?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Alunbrig (brigatinib). The Orange Book shows its last listed patent expires November 10, 2035 and its last listed exclusivity ends May 22, 2027.
What is the generic name for Alunbrig?
The active ingredient in Alunbrig is brigatinib, per the FDA Orange Book.
When does the Alunbrig patent expire?
The last patent listed for Alunbrig in the Orange Book expires November 10, 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.