FDA Orange Book · active-ingredient family
Enoxaparin sodium
Enoxaparin sodium is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:LOVENOX · NDA 020164
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LOVENOXRLD×9 | SANOFI AVENTIS US | NDA 020164 | AB | Jan 23, 2003 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE)×7 | HEBEI CHANGSHAN | ANDA 218775 | AP | Jan 07, 2026 | |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE)×7 | BE PHARMS | ANDA 214646 | AP | Jun 06, 2023 | |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE)×7 | SHENZHEN TECHDOW | ANDA 205660 | AP | Mar 15, 2023 | |
| ENOXAPARIN SODIUM | EMERGE BIOSCIENCE | ANDA 214856 | AB | Jun 14, 2022 | |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE)×7 | EMERGE BIOSCIENCE | ANDA 206834 | AP | Nov 29, 2019 | |
| ENOXAPARIN SODIUM | AMPHASTAR PHARMS INC | ANDA 208600 | AB | Mar 14, 2019 | |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE)×7 | GLAND | ANDA 078990 | AP | Sep 28, 2018 | |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE)×7 | ZYDUS PHARMS | ANDA 076726 | AP | Jun 23, 2014 | |
| ENOXAPARIN SODIUM | SANDOZ INC | ANDA 078660 | AB | Nov 28, 2011 | |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE)×7 | AMPHASTAR PHARM | ANDA 076684 | AP | Sep 19, 2011 | |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE)×7 | SANDOZ | ANDA 077857 | AP | Jul 23, 2010 |
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.
Enoxaparin sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
