FDA Orange Book · active-ingredient family
Esomeprazole sodium
Esomeprazole sodium: 1 brand, 8 generics; first approved Mar 31, 2005; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
0
Presentations
14
Brand (NDA) products
Originator applications
- NEXIUM IVRLDASTRAZENECANDA 02168920052 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued —
Generic (ANDA) products (8)
Abbreviated applications
- ESOMEPRAZOLE SODIUMEPIC PHARMA LLCANDA 2140462025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - ESOMEPRAZOLE SODIUMRSSLATE RUN PHARMAANDA 2157322022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - ESOMEPRAZOLE SODIUMRSGLANDANDA 20334920202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/VIAL INJECTABLE INTRAVENOUS Rx — EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - ESOMEPRAZOLE SODIUMPHARMOBEDIENTANDA 20268620172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — - ESOMEPRAZOLE SODIUMDEVA HOLDING ASANDA 2071812017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Rx AP - ESOMEPRAZOLE SODIUMEUGIA PHARMAANDA 20465720162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — - ESOMEPRAZOLE SODIUMACCORD HLTHCAREANDA 2053792015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — - ESOMEPRAZOLE SODIUMSUN PHARMANDA 20088220132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued — EQ 40MG BASE/VIAL INJECTABLE INTRAVENOUS Discontinued —
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
21 yr 8 mo ago
Most recent approval
1 yr 7 mo ago
Approvals span 2005–2025 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Esomeprazole 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.
