FDA Orange Book · active-ingredient family
Linezolid
Linezolid is approved as 4 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · NDA 206473
4
Brand (NDA)
25
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for suspension, solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LINEZOLID IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERRLD | HOSPIRA | NDA 206473 | — | Jun 18, 2015 | |
| ZYVOXRLD | PFIZER | NDA 021132 | AB | Apr 18, 2000 | |
| ZYVOXRLD×3 | PFIZER | NDA 021131 | AP | Apr 18, 2000 | |
| ZYVOXRLD×2 | PFIZER | NDA 021130 | — | Apr 18, 2000 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LINEZOLID | CAPLIN | ANDA 219558 | AP | Dec 08, 2025 | |
| LINEZOLID | MACLEODS PHARMS LTD | ANDA 210378 | — | Oct 10, 2024 | |
| LINEZOLID | HETERO LABS | ANDA 211813 | AB | Oct 31, 2022 | |
| LINEZOLID | HIKMA | ANDA 206454 | AP | Aug 22, 2022 | |
| LINEZOLID | CHARTWELL RX | ANDA 210702 | AB | Apr 25, 2019 | |
| LINEZOLID×2 | PHARMOBEDIENT | ANDA 205154 | AP | Dec 06, 2017 | |
| LINEZOLID×2 | HQ SPCLT PHARMA | ANDA 207001 | AP | Jul 07, 2017 | |
| LINEZOLID×2 | SAGENT PHARMS INC | ANDA 204696 | AP | Mar 02, 2017 | |
| LINEZOLID | ZYDUS PHARMS | ANDA 206097 | AB | Feb 22, 2017 | |
| LINEZOLID×2 | NANG KUANG PHARM CO | ANDA 207354 | AP | Dec 20, 2016 | |
| LINEZOLID | NOVEL LABS INC | ANDA 207526 | AB | Aug 22, 2016 | |
| LINEZOLID | EUGIA PHARMA | ANDA 206917 | AP | Aug 04, 2016 | |
| LINEZOLID | FRESENIUS KABI USA | ANDA 204764 | AP | Mar 15, 2016 | |
| LINEZOLID | GATE PHARMS | ANDA 091210 | — | Feb 05, 2016 | |
| LINEZOLID | ALEMBIC | ANDA 205233 | AB | Dec 21, 2015 | |
| LINEZOLID | ALKEM LABS LTD | ANDA 205517 | AB | Dec 21, 2015 | |
| LINEZOLID | AMNEAL PHARMS | ANDA 204536 | — | Dec 21, 2015 | |
| LINEZOLID | GLENMARK SPECLT | ANDA 078987 | AB | Dec 21, 2015 | |
| LINEZOLID | HETERO LABS LTD V | ANDA 204239 | AB | Dec 21, 2015 | |
| LINEZOLID | RISING | ANDA 078845 | AB | Dec 21, 2015 | |
| LINEZOLID×2 | SANDOZ | ANDA 200904 | AP | Jul 16, 2015 | |
| LINEZOLID | HOSPIRA | ANDA 205442 | — | Jul 07, 2015 | |
| LINEZOLID | HIKMA | ANDA 200068 | AB | Jun 03, 2015 | |
| LINEZOLID | TEVA PHARMS USA | ANDA 078061 | — | May 18, 2015 | |
| LINEZOLID | TEVA PHARMS | ANDA 200222 | — | Jun 27, 2012 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Linezolid — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
