FDA Orange Book · active-ingredient family
Esomeprazole magnesium
Esomeprazole magnesium: 6 brands, 49 generics; first approved Feb 20, 2001; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 49 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
6
Generics (ANDA)
49
Listed patents
2
Next patent expiry
Dec 08, 2036
in 10 yr 6 mo
Brand (NDA) products
Originator applications
- ESOMEPRAZOLE MAGNESIUMRLDDEXCELNDA 2142782020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE ORAL Discontinued — - ASTRAZENECA LPNDA 2079202015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL OTC — - ASTRAZENECA LPNDA 2046552014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - NEXIUMRLDASTRAZENECANDA 02195720114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - NEXIUMRLDASTRAZENECANDA 0221012008
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - NEXIUMRLDASTRAZENECANDA 02115320012 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB
Generic (ANDA) products (49)
Abbreviated applications
- ESOMEPRAZOLE MAGNESIUMAUROBINDO PHARMA LTDANDA 21894820253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMAUROBINDO PHARMA LTDANDA 2192132025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMTORRENTANDA 21265120254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMTORRENTANDA 2126522025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMCIPLAANDA 21771420252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2.5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 5MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMMACLEODS PHARMS LTDANDA 20851120242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMGLENMARK SPECLTANDA 2180922024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMDR REDDYSANDA 2071982024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMZHEJIANG YONGTAIANDA 21702220232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMGRANULESANDA 21742720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMMARKSANS PHARMAANDA 2172642023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMAUROBINDO PHARMA LTDANDA 2144732023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMZYDUS PHARMSANDA 20605520232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMPRINSTON INCANDA 21492020232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMGUARDIAN DRUGANDA 2161492023
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMGRAVITI PHARMSANDA 2163492022
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMETHYPHARMANDA 09084120212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMGRAVITI PHARMSANDA 21348620212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMINDCHEMIE HEALTHANDA 21055920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMGUANGZHOU NOVAKENANDA 21385920202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMCSPC OUYIANDA 21294920202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMCISENANDA 21315820202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMMYLANANDA 2120882020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMHETERO LABS LTD IIIANDA 21197720202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMHETERO LABS LTD IIIANDA 2125072020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMHETERO LABS LTD IIIANDA 2089392020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMDR REDDYSANDA 2115712020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMSUN PHARMANDA 2128662020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMCIPLAANDA 2117522020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 10MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMCIPLAANDA 21175120202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB EQ 40MG BASE/PACKET FOR SUSPENSION, DELAYED RELEASE ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMPHARMOBEDIENTANDA 2123762019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMAMNEAL PHARMS NYANDA 2097162019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMZYDUS PHARMSANDA 20629620192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMGLENMARK SPECLTANDA 20949520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMAMNEAL PHARMS NYANDA 20964720192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMP AND LANDA 2092022019
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE TABLET, DELAYED RELEASE ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMHEC PHARMANDA 20726520182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMDR REDDYSANDA 2076732018
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMSUN PHARMANDA 20973520182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMALKEM LABS LTDANDA 20833320172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMAUROBINDO PHARMAANDA 2093392017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMLANNETT CO INCANDA 20556320172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMPERRIGO R AND DANDA 2071932017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED RELEASE ORAL OTC — - ESOMEPRAZOLE MAGNESIUMAUROBINDO PHARMA LTDANDA 20560620162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMTORRENTANDA 20363620152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMDR REDDYSANDA 07827920152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMHETERO LABS LTD IIIANDA 20278420152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — - ESOMEPRAZOLE MAGNESIUMMYLANANDA 07893620152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Rx AB - ESOMEPRAZOLE MAGNESIUMCIPLAANDA 07800320152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 20MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued — EQ 40MG BASE CAPSULE, DELAYED REL PELLETS ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10076494 | in 10 yr 6 mo | Product | |
| 10835488 | in 10 yr 6 mo | Product |
Approval history
FDA approval span
First approval
25 yr 10 mo ago
Most recent approval
1 yr 4 mo ago
Approvals span 2001–2025 across 55 FDA applications.
Brand (NDA) 611%
Generic (ANDA) 4989%
Esomeprazole magnesium: 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.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
