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FDA Orange Book · active-ingredient family

Omeprazole; sodium bicarbonate

Omeprazole; sodium bicarbonate: 5 brands, 16 generics; first approved Jun 15, 2004; generic available.

Generic availableHas discontinued products
Generic status & protection

Generic available — 16 ANDA applications approved.

Earliest patent expiry Jul 16, 2039
Brands (NDA)
5
Generics (ANDA)
16
Listed patents
8
Next patent expiry
Jul 16, 2039
in 13 yr 2 mo
Originator applications

Brand (NDA) products

KONVOMEPRLDRS
NDA 2135932022
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
2MG/ML;84MG/MLFOR SUSPENSIONORALRx—
ZEGERID OTCRLDRS
NDA 0222832013
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG/PACKET;1.68GM/PACKETFOR SUSPENSIONORALOTC—
ZEGERID OTCRLDRS
NDA 0222812009
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALOTC—
ZEGERIDRLD
NDA 02184920062 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULEORALDiscontinued—
40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULEORALDiscontinued—
ZEGERIDRLD
NDA 02163620042 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSIONORALDiscontinued—
40MG/PACKET;1.68GM/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**FOR SUSPENSIONORALDiscontinued—
Abbreviated applications

Generic (ANDA) products (16)

OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 21916120252 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG/PACKET;1.68GM/PACKETFOR SUSPENSIONORALRxAB
40MG/PACKET;1.68GM/PACKETFOR SUSPENSIONORALRxAB
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 2177842024
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG/PACKET;1.68GM/PACKETFOR SUSPENSIONORALOTC—
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 21258720202 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALRxAB
40MG;1.1GMCAPSULEORALRxAB
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 20329020182 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALRxAB
40MG;1.1GMCAPSULEORALRxAB
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 2033452018
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALOTC—
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 20747620162 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALRxAB
40MG;1.1GMCAPSULEORALRxAB
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 2049232016
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALOTC—
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 20492220162 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALRxAB
40MG;1.1GMCAPSULEORALRxAB
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 20554520162 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG/PACKET;1.68GM/PACKETFOR SUSPENSIONORALRxAB
40MG/PACKET;1.68GM/PACKETFOR SUSPENSIONORALRxAB
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 20422820162 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALRxAB
40MG;1.1GMCAPSULEORALRxAB
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 2041372016
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALDiscontinued—
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 20406820162 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALRxAB
40MG;1.1GMCAPSULEORALRxAB
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 2013612016
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALOTC—
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 2019462016
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALDiscontinued—
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 07918220132 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG/PACKET;1.68GM/PACKETFOR SUSPENSIONORALRxAB
40MG/PACKET;1.68GM/PACKETFOR SUSPENSIONORALRxAB
OMEPRAZOLE AND SODIUM BICARBONATE
ANDA 07896620102 strengths
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
20MG;1.1GMCAPSULEORALDiscontinued—
40MG;1.1GMCAPSULEORALDiscontinued—
Protection horizon

Patent & exclusivity timeline

20262028203020322034203620382040TodayPatent 11911473 — 2039-07-16Patent 11911473Patent 12440566 — 2039-07-16Patent 12440566Patent 12329752 — 2039-07-16Patent 12329752Patent 10751333 — 2039-07-16Patent 10751333Patent 11103492 — 2039-07-16Patent 11103492Patent 11633478 — 2039-07-16Patent 11633478Patent 12042539 — 2039-07-16Patent 12042539Patent 11771686 — 2040-03-01Patent 11771686
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11911473Jul 16, 2039in 13 yr 2 mo
U-623
12440566Jul 16, 2039in 13 yr 2 mo
Product
12329752Jul 16, 2039in 13 yr 2 mo
Product
10751333Jul 16, 2039in 13 yr 2 mo
Product
11103492Jul 16, 2039in 13 yr 2 mo
Product
11633478Jul 16, 2039in 13 yr 2 mo
Product
12042539Jul 16, 2039in 13 yr 2 mo
Product
11771686Mar 01, 2040in 13 yr 10 mo
U-623
FDA approval span

Approval history

First approval
Jun 15, 2004
22 yr 5 mo ago
Most recent approval
Dec 10, 2025
7 mo ago

Approvals span 2004–2025 across 21 FDA applications.

Brand (NDA) 524%
Generic (ANDA) 1676%

Omeprazole; sodium bicarbonate — 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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