FDA Orange Book
Is there a generic for Hyrnuo?
Hyrnuo contains sevabertinib. 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 Hyrnuo (sevabertinib). The Orange Book shows its last listed patent expires November 14, 2043 and its last listed exclusivity ends November 19, 2030.
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Hyrnuo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 0 | None |
NDA 219972, held by BAYER HEALTHCARE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Hyrnuo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10428063 | October 10, 2035 | Drug substance, Drug product | None | 219972 |
| 12679836 | November 14, 2043 | Drug substance, Drug product | U-4582 | 219972 |
Hyrnuo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | November 19, 2030 | 219972 |
Hyrnuo NDC codes
Questions
Is there a generic for Hyrnuo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Hyrnuo (sevabertinib). The Orange Book shows its last listed patent expires November 14, 2043 and its last listed exclusivity ends November 19, 2030.
What is the generic name for Hyrnuo?
The active ingredient in Hyrnuo is sevabertinib, per the FDA Orange Book.
When does the Hyrnuo patent expire?
The last patent listed for Hyrnuo in the Orange Book expires November 14, 2043. 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.