FDA Orange Book
Is there a generic for Zelsuvmi?
Zelsuvmi contains berdazimer. 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 Zelsuvmi (berdazimer). The Orange Book shows its last listed patent expires July 10, 2035 and its last listed exclusivity ends January 5, 2029.
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Zelsuvmi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | EQ 10.3% BASE | Marketed (Rx) | None | 0 | None |
NDA 217424, held by LNHC INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zelsuvmi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8956658 | May 30, 2026 | Drug substance | None | 217424 |
| 8282967 | May 30, 2026 | Drug substance | None | 217424 |
| 9737561 | August 20, 2030 | Method of use | U-3802 | 217424 |
| 10376538 | August 20, 2030 | Drug product | None | 217424 |
| 9526738 | September 3, 2031 | Drug product | None | 217424 |
| 9289442 | July 3, 2032 | Drug product | U-3803 | 217424 |
| 10265334 | July 3, 2032 | Drug product | None | 217424 |
| 9855211 | February 27, 2034 | Drug product | U-3800 | 217424 |
| 9855211 | February 27, 2034 | Drug product | U-3801 | 217424 |
| 11285098 | February 28, 2034 | Drug product | None | 217424 |
| 10258564 | November 22, 2034 | Method of use | U-3797 | 217424 |
| 10258564 | November 22, 2034 | Method of use | U-3798 | 217424 |
| 10258564 | November 22, 2034 | Method of use | U-3799 | 217424 |
| 11723858 | July 10, 2035 | Drug product | U-3788 | 217424 |
| 11040006 | July 10, 2035 | Drug product | U-3789 | 217424 |
| 10736839 | July 10, 2035 | Method of use | U-3790 | 217424 |
| 10736839 | July 10, 2035 | Method of use | U-3791 | 217424 |
| 10736839 | July 10, 2035 | Method of use | U-3792 | 217424 |
| 10322081 | July 10, 2035 | Method of use | U-3793 | 217424 |
| 10322081 | July 10, 2035 | Method of use | U-3794 | 217424 |
| 10322081 | July 10, 2035 | Method of use | U-3795 | 217424 |
| 10322081 | July 10, 2035 | Method of use | U-3796 | 217424 |
Zelsuvmi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | January 5, 2029 | 217424 |
Questions
Is there a generic for Zelsuvmi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zelsuvmi (berdazimer). The Orange Book shows its last listed patent expires July 10, 2035 and its last listed exclusivity ends January 5, 2029.
What is the generic name for Zelsuvmi?
The active ingredient in Zelsuvmi is berdazimer, per the FDA Orange Book.
When does the Zelsuvmi patent expire?
The last patent listed for Zelsuvmi in the Orange Book expires July 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.