Orange Book product · Brand (NDA)
BAXDELA
DELAFLOXACIN MEGLUMINE
At a glance
Jun 19, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
13
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 19, 2017
9 yr 2 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jun 19, 2022
4 yr 1 mo ago
Today
Patent 8273892 expires
Listed drug substance patent expiration.
Aug 06, 2026
in 2 mo
Patent 8252813 expires
Listed drug product patent expiration.
Oct 02, 2026
in 4 mo
Exclusivity ends · GAIN
Qualified infectious disease product exclusivity (adds 5 years)
Jun 19, 2027
in 1 yr
Patent 7635773 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 8410077 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9200088 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9750822 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 8871938 expires
Listed drug substance patent expiration.
Sep 23, 2029
in 3 yr 4 mo
Patent RE46617 expires
Listed drug substance patent expiration.
Dec 28, 2029
in 3 yr 7 mo
Patent 7728143 expires
Listed drug substance patent expiration.
Jun 19, 2031
in 5 yr 1 mo
Patent 12138257 expires
Listed drug product patent expiration.
May 01, 2032
in 5 yr 11 mo
Patent 9493582 expires
Listed drug product patent expiration.
Feb 27, 2033
in 6 yr 10 mo
Patent 12558349 expires
Listed method-of-use patent (U-3967) expiration.
Mar 14, 2034
in 7 yr 10 mo
Patent 12036219 expires
Listed method-of-use patent (U-3967) expiration.
Jun 02, 2034
in 8 yr 1 mo
Pharmaceutical detail
Active ingredient
DELAFLOXACIN MEGLUMINE
Strength
EQ 300MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 208611
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)
Jun 19, 2022
4 yr 1 mo ago
- GAINQualified infectious disease product exclusivity (adds 5 years)
Jun 19, 2027
in 1 yr
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8273892 | Aug 06, 2026 | in 2 mo | Substance |
| 8252813 | Oct 02, 2026 | in 4 mo | ProductU-2028 |
| 7635773 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 8410077 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 9200088 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 9750822 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 8871938 | Sep 23, 2029 | in 3 yr 4 mo | Substance |
| RE46617 | Dec 28, 2029 | in 3 yr 7 mo | Substance |
| 7728143 | Jun 19, 2031 | in 5 yr 1 mo | Substance |
| 12138257 | May 01, 2032 | in 5 yr 11 mo | Product |
| 9493582 | Feb 27, 2033 | in 6 yr 10 mo | Product |
| 12558349 | Mar 14, 2034 | in 7 yr 10 mo | U-3967 |
| 12036219 | Jun 02, 2034 | in 8 yr 1 mo | U-3967 |
