FDA Orange Book
Is there a generic for Zegfrovy?
Zegfrovy contains sunvozertinib. 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 Zegfrovy (sunvozertinib). The Orange Book shows its last listed patent expires January 28, 2039 and its last listed exclusivity ends July 2, 2030.
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Zegfrovy 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 | 200MG | Marketed (Rx) | None | 0 | None |
NDA 219839, held by DIZAL PHARMACEUTICAL CO LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zegfrovy patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11504375 | January 28, 2039 | Drug substance, Drug product | U-3220 | 219839 |
| 11896597 | January 28, 2039 | Drug substance, Drug product | U-3220 | 219839 |
| 11007198 | January 28, 2039 | Drug substance, Drug product | None | 219839 |
Zegfrovy exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 2, 2030 | 219839 |
Zegfrovy NDC codes
Questions
Is there a generic for Zegfrovy?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zegfrovy (sunvozertinib). The Orange Book shows its last listed patent expires January 28, 2039 and its last listed exclusivity ends July 2, 2030.
What is the generic name for Zegfrovy?
The active ingredient in Zegfrovy is sunvozertinib, per the FDA Orange Book.
When does the Zegfrovy patent expire?
The last patent listed for Zegfrovy in the Orange Book expires January 28, 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.