FDA Orange Book
Is there a generic for Filsuvez?
Filsuvez contains birch triterpenes. 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 Filsuvez (birch triterpenes). The Orange Book shows its last listed patent expires January 4, 2039 and its last listed exclusivity ends December 18, 2030.
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Filsuvez products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, topical | 10% | Marketed (Rx) | None | 0 | None |
NDA 215064, held by CHIESI FARMACEUTICI SPA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Filsuvez patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8828444 | June 21, 2027 | Drug product | None | 215064 |
| 9827214 | November 24, 2030 | Method of use | U-3811 | 215064 |
| 9352041 | November 24, 2030 | Method of use | U-3811 | 215064 |
| 11266660 | January 4, 2039 | Method of use | U-3811 | 215064 |
| 12268695 | January 4, 2039 | Method of use | U-3811 | 215064 |
| 11083733 | January 4, 2039 | Drug product | None | 215064 |
Filsuvez exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 18, 2028 | 215064 |
| ODE-460 | Orphan drug exclusivity | December 18, 2030 | 215064 |
Filsuvez NDC codes
Questions
Is there a generic for Filsuvez?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Filsuvez (birch triterpenes). The Orange Book shows its last listed patent expires January 4, 2039 and its last listed exclusivity ends December 18, 2030.
What is the generic name for Filsuvez?
The active ingredient in Filsuvez is birch triterpenes, per the FDA Orange Book.
When does the Filsuvez patent expire?
The last patent listed for Filsuvez in the Orange Book expires January 4, 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.