FDA Orange Book · active-ingredient family
Berdazimer sodium
Berdazimer sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ZELSUVMI · NDA 217424
1
Brand (NDA)
0
Generics (ANDA)
14
Listed patents
1
Exclusivity periods
Brand (NDA) products · gel
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZELSUVMIRLD | LNHC | NDA 217424 | — | Jan 05, 2024 |
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Jan 05, 2029
in 2 yr 7 mo
Listed patents (14)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8956658 | May 30, 2026 | 20 d ago | Substance |
| 8282967 | May 30, 2026 | 20 d ago | Substance |
| 9737561 | Aug 20, 2030 | in 4 yr 3 mo | U-3802 |
| 10376538 | Aug 20, 2030 | in 4 yr 3 mo | Product |
| 9526738 | Sep 03, 2031 | in 5 yr 3 mo | Product |
| 9289442 | Jul 03, 2032 | in 6 yr 2 mo | ProductU-3803 |
| 10265334 | Jul 03, 2032 | in 6 yr 2 mo | Product |
| 9855211 | Feb 27, 2034 | in 7 yr 10 mo | ProductU-3800 |
| 11285098 | Feb 28, 2034 | in 7 yr 10 mo | Product |
| 10258564 | Nov 22, 2034 | in 8 yr 7 mo | U-3797 |
| 11723858 | Jul 10, 2035 | in 9 yr 2 mo | ProductU-3788 |
| 11040006 | Jul 10, 2035 | in 9 yr 2 mo | ProductU-3789 |
| 10736839 | Jul 10, 2035 | in 9 yr 2 mo | U-3790 |
| 10322081 | Jul 10, 2035 | in 9 yr 2 mo | U-3793 |
Berdazimer sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
