FDA Orange Book
Is there a generic for Vtama?
Vtama contains tapinarof. 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 Vtama (tapinarof). The Orange Book shows its last listed patent expires December 18, 2039 and its last listed exclusivity ends December 12, 2027.
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Vtama products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 1% | Marketed (Rx) | None | 0 | None |
NDA 215272, held by ORGANON LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Vtama patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10426743 | May 19, 2036 | Method of use | U-4048 | 215272 |
| 11612573 | May 19, 2036 | Method of use | U-4048 | 215272 |
| 11612573 | May 19, 2036 | Method of use | U-2625 | 215272 |
| 10426743 | May 19, 2036 | Method of use | U-2625 | 215272 |
| 11617724 | May 19, 2036 | Drug product | None | 215272 |
| 11622945 | May 19, 2036 | Drug product | None | 215272 |
| 11458108 | May 19, 2036 | Drug product | None | 215272 |
| 10195160 | May 23, 2036 | Drug product | None | 215272 |
| 10647649 | November 13, 2038 | Drug substance | None | 215272 |
| 11597692 | November 13, 2038 | Drug substance, Drug product | None | 215272 |
| 11590088 | November 13, 2039 | Method of use | U-2625 | 215272 |
| 11497718 | November 13, 2039 | Method of use | U-4048 | 215272 |
| 11938099 | November 13, 2039 | Method of use | U-4048 | 215272 |
| 12569453 | December 18, 2039 | Method of use | U-4048 | 215272 |
Vtama exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 23, 2027 | 215272 |
| I-956 | New indication | December 12, 2027 | 215272 |
Vtama NDC codes
Questions
Is there a generic for Vtama?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Vtama (tapinarof). The Orange Book shows its last listed patent expires December 18, 2039 and its last listed exclusivity ends December 12, 2027.
What is the generic name for Vtama?
The active ingredient in Vtama is tapinarof, per the FDA Orange Book.
When does the Vtama patent expire?
The last patent listed for Vtama in the Orange Book expires December 18, 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.