Orange Book product · Brand (NDA)
NUZOLVENCE
ZOLIFLODACIN
At a glance
Dec 12, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 12, 2025
6 mo ago
Today
Patent 9040528 expires
Listed method-of-use patent (U-4369) expiration.
Oct 13, 2029
in 3 yr 4 mo
Patent 8658641 expires
Listed drug substance patent expiration.
Jun 20, 2030
in 4 yr 1 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Dec 12, 2030
in 4 yr 7 mo
Patent 8889671 expires
Listed drug substance patent expiration.
Jan 21, 2034
in 7 yr 8 mo
Patent 9187495 expires
Listed drug substance patent expiration.
Jan 21, 2034
in 7 yr 8 mo
Patent 9540394 expires
Listed method-of-use patent (U-4369) expiration.
Jan 21, 2034
in 7 yr 8 mo
Patent 9839641 expires
Listed method-of-use patent (U-4369) expiration.
Jan 21, 2034
in 7 yr 8 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Dec 12, 2035
in 9 yr 7 mo
Pharmaceutical detail
Active ingredient
ZOLIFLODACIN
Strength
3GM/PACKET
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 219491
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 12, 2030
in 4 yr 7 mo
- GAINQualified infectious disease product exclusivity (adds 5 years)
Dec 12, 2035
in 9 yr 7 mo
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9040528 | Oct 13, 2029 | in 3 yr 4 mo | U-4369 |
| 8658641 | Jun 20, 2030 | in 4 yr 1 mo | Substance |
| 8889671 | Jan 21, 2034 | in 7 yr 8 mo | SubstanceU-4369 |
| 9187495 | Jan 21, 2034 | in 7 yr 8 mo | SubstanceU-4369 |
| 9540394 | Jan 21, 2034 | in 7 yr 8 mo | U-4369 |
| 9839641 | Jan 21, 2034 | in 7 yr 8 mo | U-4369 |
