Orange Book product · Brand (NDA)
ZELSUVMI
BERDAZIMER SODIUM
At a glance
Jan 05, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
22
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 05, 2024
2 yr 6 mo ago
Patent 8282967 expires
Listed drug substance patent expiration.
May 30, 2026
20 d ago
Patent 8956658 expires
Listed drug substance patent expiration.
May 30, 2026
20 d ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 05, 2029
in 2 yr 7 mo
Patent 10376538 expires
Listed drug product patent expiration.
Aug 20, 2030
in 4 yr 3 mo
Patent 9737561 expires
Listed method-of-use patent (U-3802) expiration.
Aug 20, 2030
in 4 yr 3 mo
Patent 9526738 expires
Listed drug product patent expiration.
Sep 03, 2031
in 5 yr 3 mo
Patent 10265334 expires
Listed drug product patent expiration.
Jul 03, 2032
in 6 yr 2 mo
Patent 9289442 expires
Listed drug product patent expiration.
Jul 03, 2032
in 6 yr 2 mo
Patent 9855211 expires
Listed drug product patent expiration.
Feb 27, 2034
in 7 yr 10 mo
Patent 9855211 expires
Listed drug product patent expiration.
Feb 27, 2034
in 7 yr 10 mo
Patent 11285098 expires
Listed drug product patent expiration.
Feb 28, 2034
in 7 yr 10 mo
Patent 10258564 expires
Listed method-of-use patent (U-3797) expiration.
Nov 22, 2034
in 8 yr 7 mo
Patent 10258564 expires
Listed method-of-use patent (U-3798) expiration.
Nov 22, 2034
in 8 yr 7 mo
Patent 10258564 expires
Listed method-of-use patent (U-3799) expiration.
Nov 22, 2034
in 8 yr 7 mo
Patent 10322081 expires
Listed method-of-use patent (U-3793) expiration.
Jul 10, 2035
in 9 yr 2 mo
Patent 10322081 expires
Listed method-of-use patent (U-3794) expiration.
Jul 10, 2035
in 9 yr 2 mo
Patent 10322081 expires
Listed method-of-use patent (U-3795) expiration.
Jul 10, 2035
in 9 yr 2 mo
Patent 10322081 expires
Listed method-of-use patent (U-3796) expiration.
Jul 10, 2035
in 9 yr 2 mo
Patent 10736839 expires
Listed method-of-use patent (U-3790) expiration.
Jul 10, 2035
in 9 yr 2 mo
Patent 10736839 expires
Listed method-of-use patent (U-3791) expiration.
Jul 10, 2035
in 9 yr 2 mo
Patent 10736839 expires
Listed method-of-use patent (U-3792) expiration.
Jul 10, 2035
in 9 yr 2 mo
Patent 11040006 expires
Listed drug product patent expiration.
Jul 10, 2035
in 9 yr 2 mo
Patent 11723858 expires
Listed drug product patent expiration.
Jul 10, 2035
in 9 yr 2 mo
Pharmaceutical detail
Active ingredient
BERDAZIMER SODIUM
Strength
EQ 10.3% BASE
Dosage form
GEL
Route
TOPICAL
TE code
Not listed
Application
NDA 217424
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 (1)
- NCENew chemical entity exclusivity (5 years)
Jan 05, 2029
in 2 yr 7 mo
Listed patents (22)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8282967 | May 30, 2026 | 20 d ago | Substance |
| 8956658 | May 30, 2026 | 20 d ago | Substance |
| 10376538 | Aug 20, 2030 | in 4 yr 3 mo | Product |
| 9737561 | Aug 20, 2030 | in 4 yr 3 mo | U-3802 |
| 9526738 | Sep 03, 2031 | in 5 yr 3 mo | Product |
| 10265334 | Jul 03, 2032 | in 6 yr 2 mo | Product |
| 9289442 | Jul 03, 2032 | in 6 yr 2 mo | ProductU-3803 |
| 9855211 | Feb 27, 2034 | in 7 yr 10 mo | ProductU-3800 |
| 9855211 | Feb 27, 2034 | in 7 yr 10 mo | ProductU-3801 |
| 11285098 | Feb 28, 2034 | in 7 yr 10 mo | Product |
| 10258564 | Nov 22, 2034 | in 8 yr 7 mo | U-3797 |
| 10258564 | Nov 22, 2034 | in 8 yr 7 mo | U-3798 |
| 10258564 | Nov 22, 2034 | in 8 yr 7 mo | U-3799 |
| 10322081 | Jul 10, 2035 | in 9 yr 2 mo | U-3793 |
| 10322081 | Jul 10, 2035 | in 9 yr 2 mo | U-3794 |
| 10322081 | Jul 10, 2035 | in 9 yr 2 mo | U-3795 |
| 10322081 | Jul 10, 2035 | in 9 yr 2 mo | U-3796 |
| 10736839 | Jul 10, 2035 | in 9 yr 2 mo | U-3790 |
| 10736839 | Jul 10, 2035 | in 9 yr 2 mo | U-3791 |
| 10736839 | Jul 10, 2035 | in 9 yr 2 mo | U-3792 |
| 11040006 | Jul 10, 2035 | in 9 yr 2 mo | ProductU-3789 |
| 11723858 | Jul 10, 2035 | in 9 yr 2 mo | ProductU-3788 |
