Orange Book product · Brand (NDA)
FILSUVEZ
BIRCH TRITERPENES
At a glance
Dec 18, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 18, 2023
2 yr 6 mo ago
Today
Patent 8828444 expires
Listed drug product patent expiration.
Jun 21, 2026
in 2 d
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 18, 2028
in 2 yr 6 mo
Patent 9352041 expires
Listed method-of-use patent (U-3811) expiration.
Nov 24, 2030
in 4 yr 6 mo
Patent 9827214 expires
Listed method-of-use patent (U-3811) expiration.
Nov 24, 2030
in 4 yr 6 mo
Exclusivity ends · ODE-460
Orphan-drug exclusivity (7 years)
Dec 18, 2030
in 4 yr 7 mo
Patent 11083733 expires
Listed drug product patent expiration.
Jan 04, 2039
in 12 yr 9 mo
Patent 11266660 expires
Listed method-of-use patent (U-3811) expiration.
Jan 04, 2039
in 12 yr 9 mo
Patent 12268695 expires
Listed method-of-use patent (U-3811) expiration.
Jan 04, 2039
in 12 yr 9 mo
Pharmaceutical detail
Active ingredient
BIRCH TRITERPENES
Strength
10%
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
NDA 215064
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (2)
- NCENew chemical entity exclusivity (5 years)
Dec 18, 2028
in 2 yr 6 mo
- ODE-460Orphan-drug exclusivity (7 years)
Dec 18, 2030
in 4 yr 7 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8828444 | Jun 21, 2026 | in 2 d | Product |
| 9352041 | Nov 24, 2030 | in 4 yr 6 mo | U-3811 |
| 9827214 | Nov 24, 2030 | in 4 yr 6 mo | U-3811 |
| 11083733 | Jan 04, 2039 | in 12 yr 9 mo | Product |
| 11266660 | Jan 04, 2039 | in 12 yr 9 mo | U-3811 |
| 12268695 | Jan 04, 2039 | in 12 yr 9 mo | U-3811 |
