FDA Orange Book · active-ingredient family
Cefixime
Cefixime is approved as 4 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SUPRAX · NDA 202091
4
Brand (NDA)
13
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for suspension, tablet, tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SUPRAXRLD | LUPIN LTD | NDA 202091 | AB | Feb 20, 2013 | |
| SUPRAXRLD | LUPIN LTD | NDA 203195 | AB | Jun 01, 2012 | |
| SUPRAXRLD | LEDERLE | NDA 050622 | — | Apr 28, 1989 | |
| SUPRAXRLD×2 | LEDERLE | NDA 050621 | — | Apr 28, 1989 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CEFIXIME×2 | FDC LTD | ANDA 218691 | AB | May 14, 2026 | |
| CEFIXIME | AUROBINDO PHARMA LTD | ANDA 217607 | AB | Mar 23, 2026 | |
| CEFIXIME | FDC LTD | ANDA 206358 | — | Dec 17, 2024 | |
| CEFIXIME×2 | ALKEM LABS LTD | ANDA 211775 | AB | Feb 19, 2021 | |
| CEFIXIME | ALKEM LABS LTD | ANDA 210574 | AB | Oct 09, 2018 | |
| CEFIXIME×2 | CHARTWELL RX | ANDA 206144 | — | Nov 17, 2017 | |
| CEFIXIME×2 | AJENAT PHARMS | ANDA 206938 | AB | Feb 06, 2017 | |
| CEFIXIME | AJENAT PHARMS | ANDA 206939 | AB | Feb 06, 2017 | |
| CEFIXIME×2 | AUROBINDO PHARMA LTD | ANDA 204835 | AB | Apr 14, 2015 | |
| SUPRAX×3 | LUPIN LTD | ANDA 065380 | — | Oct 25, 2010 | |
| SUPRAX | LUPIN PHARMS | ANDA 065355 | AB | Apr 10, 2007 | |
| SUPRAX | LUPIN PHARMS | ANDA 065129 | — | Feb 23, 2004 | |
| SUPRAX | LUPIN PHARMS | ANDA 065130 | — | Feb 12, 2004 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9233112 | Dec 14, 2028 | in 2 yr 6 mo | ProductU-1676 |
Cefixime — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
