FDA Orange Book
Is there a generic for Hernexeos?
Hernexeos contains zongertinib. 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 Hernexeos (zongertinib). The Orange Book shows its last listed patent expires July 21, 2041 and its last listed exclusivity ends August 8, 2030.
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Hernexeos products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 60MG | Marketed (Rx) | None | 0 | None |
NDA 219042, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Hernexeos patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12171739 | November 15, 2026 | Drug substance, Drug product | None | 219042 |
| 11608343 | July 21, 2041 | Drug substance, Drug product | U-4245 | 219042 |
Hernexeos exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | August 8, 2030 | 219042 |
Hernexeos NDC codes
Questions
Is there a generic for Hernexeos?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Hernexeos (zongertinib). The Orange Book shows its last listed patent expires July 21, 2041 and its last listed exclusivity ends August 8, 2030.
What is the generic name for Hernexeos?
The active ingredient in Hernexeos is zongertinib, per the FDA Orange Book.
When does the Hernexeos patent expire?
The last patent listed for Hernexeos in the Orange Book expires July 21, 2041. 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.