FDA Orange Book · active-ingredient family
Enoxaparin sodium
Enoxaparin sodium: 1 brand, 11 generics; first approved Mar 29, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 11 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
11
Listed patents
0
Presentations
68
Brand (NDA) products
Originator applications
- LOVENOXRLDSANOFI AVENTIS USNDA 02016420039 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/0.3ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 40MG/0.4ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 60MG/0.6ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 80MG/0.8ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 100MG/ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 90MG/0.6ML (150MG/ML) INJECTABLE SUBCUTANEOUS Discontinued — 120MG/0.8ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 150MG/ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 300MG/3ML (100MG/ML) INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AB
Generic (ANDA) products (11)
Abbreviated applications
- HEBEI CHANGSHANANDA 21877520267 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/0.3ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 40MG/0.4ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 60MG/0.6ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 80MG/0.8ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 100MG/ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 120MG/0.8ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 150MG/ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP - BE PHARMSANDA 21464620237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/0.3ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 40MG/0.4ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 60MG/0.6ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 80MG/0.8ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 100MG/ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 120MG/0.8ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 150MG/ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP - SHENZHEN TECHDOWANDA 20566020237 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/0.3ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 40MG/0.4ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 60MG/0.6ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 80MG/0.8ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 100MG/ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 120MG/0.8ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 150MG/ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP - ENOXAPARIN SODIUMEMERGE BIOSCIENCEANDA 2148562022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/3ML (100MG/ML) INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AB - EMERGE BIOSCIENCEANDA 20683420197 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/0.3ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 40MG/0.4ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 60MG/0.6ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 80MG/0.8ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 100MG/ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 120MG/0.8ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 150MG/ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP - ENOXAPARIN SODIUMAMPHASTAR PHARMS INCANDA 2086002019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/3ML (100MG/ML) INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AB - GLANDANDA 07899020187 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/0.3ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 40MG/0.4ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 60MG/0.6ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 80MG/0.8ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 100MG/ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 120MG/0.8ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 150MG/ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP - ZYDUS PHARMSANDA 07672620147 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/0.3ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 40MG/0.4ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 60MG/0.6ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 80MG/0.8ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 100MG/ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 120MG/0.8ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 150MG/ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP - ENOXAPARIN SODIUMSANDOZ INCANDA 0786602011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 300MG/3ML (100MG/ML) INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AB - AMPHASTAR PHARMANDA 07668420117 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG/0.3ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 40MG/0.4ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 60MG/0.6ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 80MG/0.8ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 100MG/ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 120MG/0.8ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 150MG/ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP - SANDOZANDA 07785720107 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 30MG/0.3ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 40MG/0.4ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 60MG/0.6ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 80MG/0.8ML (100MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 120MG/0.8ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP 150MG/ML (150MG/ML) INJECTABLE SUBCUTANEOUS Rx AP
Listed patents
Orange Book patent file
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.
Approval history
FDA approval span
First approval
33 yr 10 mo ago
Most recent approval
7 mo ago
Approvals span 1993–2026 across 12 FDA applications.
Brand (NDA) 18%
Generic (ANDA) 1192%
Enoxaparin sodium: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
