FDA Orange Book · active-ingredient family
Delafloxacin meglumine
Delafloxacin meglumine is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:BAXDELA · NDA 208611
2
Brand (NDA)
0
Generics (ANDA)
13
Listed patents
4
Exclusivity periods
Brand (NDA) products · powder, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BAXDELARLD | MELINTA | NDA 208611 | — | Jun 19, 2017 | |
| BAXDELARLD | MELINTA | NDA 208610 | — | Jun 19, 2017 |
Marketing exclusivity (4)
- 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
- 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 |
| 9200088 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 9750822 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 7635773 | Mar 13, 2029 | in 2 yr 9 mo | Product |
| 8410077 | 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 |
Delafloxacin meglumine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
