Omeprazole - PharmaKB

Omeprazole

Konvomep, Omeclamox-pak, Omeprazole, Prilosec, Talicia, Yosprala, Zegerid (omeprazole) is a small molecule pharmaceutical. Omeprazole was first approved as Prilosec on 1989-09-14. It is used to treat duodenal ulcer, esophagitis, gastroesophageal reflux, heartburn, and helicobacter infections amongst others in the USA. The pharmaceutical is active against potassium-transporting ATPase alpha chain 1. In addition, it is known to target chloride channel protein 2.

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FDA approval date

EMA approval date

Patent expiration date

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Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
neoplasms	D009369
digestive system diseases	D004066
signs and symptoms pathological conditions	D013568

Trade Name

FDA

EMA

Omeprazole, Omeprazole magnesium, Prilosec (discontinued: Omeprazole, Omeprazole magnesium, Prilosec)

Combinations

Konvomep, Omeprazole bicarbonate, Talicia, Zegerid (discontinued: Magnesium hydroxide omeprazole bicarbonate, Omeclamox-pak, Omeprazole bicarbonate, Yosprala, Zegerid)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Omeprazole

Sodium bicarbonate

Tradename	Company	Number	Date	Products
KONVOMEP	Azurity	N-213593 RX	2022-08-30	1 products, RLD, RS
ZEGERID OTC	Riley Consumer Care Holdings	N-022281 OTC	2009-12-01	1 products, RLD, RS
ZEGERID OTC	Riley Consumer Care Holdings	N-022283 OTC	2013-06-17	1 products, RLD, RS

Show 2 discontinued

Omeprazole

Tradename	Company	Number	Date	Products
OMEPRAZOLE	Dexcel Pharma	N-209400 OTC	2017-07-05	1 products, RLD, RS
OMEPRAZOLE	Dexcel Pharma	N-022032 OTC	2007-12-04	1 products, RLD, RS

Show 1 discontinued

Aspirin

Omeprazole

Tradename	Company	Number	Date	Products
YOSPRALA	Genus Lifesciences	N-205103 DISCN	2016-09-14	2 products, RLD

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Amoxicillin

Clarithromycin

Omeprazole

Tradename	Company	Number	Date	Products
OMECLAMOX-PAK	Cumberland Pharmaceuticals	N-050824 DISCN	2011-02-08	1 products, RLD

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Magnesium hydroxide

Omeprazole

Sodium bicarbonate

Tradename	Company	Number	Date	Products
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	Santarus	N-022456 DISCN	2009-12-04	2 products
ZEGERID	Santarus	N-021850 DISCN	2006-03-24	2 products

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Amoxicillin

Omeprazole magnesium

Rifabutin

Tradename	Company	Number	Date	Products
TALICIA	RedHill Biopharma	N-213004 RX	2019-11-01	1 products, RLD, RS

Omeprazole magnesium

Tradename	Company	Number	Date	Products
PRILOSEC OTC	AstraZeneca	N-021229 OTC	2003-06-20	1 products, RLD, RS
PRILOSEC	Covis Pharma	N-022056 RX	2008-03-20	2 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
24 hr omeprazole	New Drug Application	2025-01-14
acid reducer	ANDA	2025-07-23
acid reducer powder	ANDA	2025-03-03
amazon basic care omeprazole	ANDA	2024-05-10
aspirin and omeprazole delayed-release tab	New Drug Application	2019-11-20
basic care omeprazole	New Drug Application	2025-01-22
basic care omeprazole and sodium bicarbonate	ANDA	2025-11-04
berkley and jensen omeprazole	New Drug Application	2025-03-06
care one omeprazole	New Drug Application	2025-02-06
careone omeprazole	New Drug Application	2025-04-17

Show 50 more

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
gastroesophageal reflux	EFO_0003948	D005764	K21
helicobacter infections	EFO_1000961	D016481	—
stomach ulcer	—	D013276	K25
duodenal ulcer	EFO_0004607	D004381	K26
zollinger-ellison syndrome	—	D015043	E16.4
esophagitis	HP_0100633	D004941	K20
heartburn	—	D006356	R12
rheumatoid arthritis	EFO_0000685	D001172	M06.9
pain	EFO_0003843	D010146	R52
fever	—	D005334	R50.9

Show 27 more

Agency Specific

FDA

EMA

Expiration	Code
AMOXICILLIN / OMEPRAZOLE MAGNESIUM / RIFABUTIN, TALICIA, REDHILL
2027-11-01	GAIN
2022-11-01	NP

Patent Expiration

Patent	Expires	Flag	FDA Information
Amoxicillin / Omeprazole Magnesium / Rifabutin, Talicia, Redhill
11878011	2042-05-27		U-3816
9050263	2034-02-12	DP	U-2660
9498445	2034-02-12	DP	U-2660
9603806	2034-02-12	DP	U-2660
10238606	2034-02-12	DP
11135172	2034-02-12	DP	U-2660
Omeprazole / Sodium Bicarbonate, Konvomep, Azurity
11771686	2040-03-01		U-623
10751333	2039-07-16	DP
11103492	2039-07-16	DP
11633478	2039-07-16	DP
Omeprazole, Omeprazole, Dexcel
10076494	2036-12-08	DP
10835488	2036-12-08	DP
Aspirin / Omeprazole, Yosprala, Genus Lifesciences
9539214	2033-03-13		U-1902
9987231	2033-01-02		U-2324
Omeprazole, Omeprazole, Dexcel Pharma
9023391	2025-08-16	DP

ATC Codes

A: Alimentary tract and metabolism drugs

— A02: Drugs for acid related disorders

— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)

— A02BC: Proton pump inhibitors for peptic ulcer and gord

— A02BC01: Omeprazole

— A02BD: Combinations for eradication of helicobacter pylori

— A02BD01: Omeprazole, amoxicillin and metronidazole

— A02BD05: Omeprazole, amoxicillin and clarithromycin

— A02BD16: Omeprazole, amoxicillin and rifabutin

HCPCS

No data

Clinical

Clinical Trials

1012 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Gastroesophageal reflux	D005764	EFO_0003948	K21	3	2	20	26	6	56
Peptic esophagitis	D004942	EFO_1001095	—	1	1	7	7	3	18
Esophagitis	D004941	HP_0100633	K20	2	1	7	5	3	17
Stomach ulcer	D013276	—	K25	1	—	9	1	4	15
Healthy volunteers/patients	—	—	—	8	—	—	2	—	10
Heartburn	D006356	—	R12	—	—	3	6	—	9
Dyspepsia	D004415	EFO_0008533	K30	—	1	3	2	—	6
Barrett esophagus	D001471	EFO_0000280	K22.7	1	—	1	3	—	5
Non-erosive reflux disease	D000096663	—	—	—	—	2	1	1	4
Laryngopharyngeal reflux	D057045	EFO_1001355	—	—	—	—	2	—	2

Show 15 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Ulcer	D014456	MPATH_579	—	2	—	11	—	4	17
Duodenal ulcer	D004381	EFO_0004607	K26	1	—	5	—	4	10
Gastrointestinal diseases	D005767	—	—	—	—	6	—	1	7
Peptic ulcer	D010437	—	K27	2	—	3	—	1	6
Hemorrhage	D006470	MP_0001914	R58	—	—	3	—	—	3
Digestive system diseases	D004066	EFO_0000405	K92.9	—	—	2	—	1	3
Peptic ulcer hemorrhage	D010438	—	—	—	—	2	—	—	2
Gastrinoma	D015408	—	—	—	—	1	—	1	2
Zollinger-ellison syndrome	D015043	—	E16.4	—	—	1	—	1	2
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	—	—	2	—	—	2

Show 13 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Asthma	D001249	EFO_0000270	J45	—	2	—	—	—	2

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Therapeutic equivalency	D013810	—	—	3	—	—	—	—	3
Chronic pain	D059350	—	—	1	—	—	—	—	1
Alzheimer disease	D000544	EFO_0000249	F03	1	—	—	—	—	1
Metabolism	D008660	GO_0008152	—	1	—	—	—	—	1
Juvenile arthritis	D001171	EFO_1002007	M08	1	—	—	—	—	1
Arthritis	D001168	EFO_0005856	M05-M14	1	—	—	—	—	1
Pancreatitis	D010195	EFO_0000278	K85	1	—	—	—	—	1
Chronic pancreatitis	D050500	EFO_0000342	K86.1	1	—	—	—	—	1
Pharmacokinetics	D010599	—	—	1	—	—	—	—	1
Exercise-induced asthma	D001250	—	J45.990	1	—	—	—	—	1

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Metabolic diseases	D008659	EFO_0000589	E88.9	—	—	—	—	1	1
Calcium metabolism disorders	D002128	EFO_0005769	E83.5	—	—	—	—	1	1
Recurrence	D012008	—	—	—	—	—	—	1	1
Stomach neoplasms	D013274	EFO_0003897	C16	—	—	—	—	1	1
Thrombocytopenic purpura idiopathic	D016553	EFO_0007160	D69.3	—	—	—	—	1	1
Thrombocytopenic purpura	D011696	—	—	—	—	—	—	1	1
Purpura	D011693	HP_0000979	D69.2	—	—	—	—	1	1
Rhinitis	D012220	EFO_0008521	J31	—	—	—	—	1	1
Common cold	D003139	EFO_0007214	J00	—	—	—	—	1	1
Vasomotor rhinitis	D012223	EFO_0007533	J30.0	—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	Omeprazole
INN	omeprazole
Description	6-methoxy-2-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methylsulfinyl]-1H-benzimidazole is a member of benzimidazoles and a sulfoxide.
Classification	Small molecule
Drug class	antiulcer agents (benzimidazole derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	COc1ccc2[nH]c([S+]([O-])Cc3ncc(C)c(OC)c3C)nc2c1

Identifiers

PDB	—
CAS-ID	73590-58-6
RxCUI	—
ChEMBL ID	CHEMBL1503
ChEBI ID	77260
PubChem CID	4594
DrugBank	DB00338
UNII ID	KG60484QX9 (ChemIDplus, GSRS)

Target

Agency Approved

ATP4A

Organism

Homo sapiens

Gene name

ATP4A

Gene synonyms

NCBI Gene ID

495

Protein name

potassium-transporting ATPase alpha chain 1

Protein synonyms

ATPase H+/K+ transporting alpha subunit, ATPase, H+/K+ exchanging, alpha polypeptide, ATPase, H+/K+ transporting, alpha polypeptide, epididymis secretory sperm binding protein, Gastric H(+)/K(+) ATPase subunit alpha, gastric H+/K+ ATPase alpha subunit, gastric H,K-ATPase catalytic subunit, gastric hydrogen-potassium ATPase, Proton pump

Uniprot ID

P20648

Mouse ortholog

Atp4a (11944)

potassium-transporting ATPase alpha chain 1 (Q9CV46)

Alternate

CLCN2

Organism

Homo sapiens

Gene name

CLCN2

Gene synonyms

NCBI Gene ID

1181

Protein name

chloride channel protein 2

Protein synonyms

chloride channel 2, chloride channel, voltage-sensitive 2

Uniprot ID

P51788

Mouse ortholog

Clcn2 (12724)

chloride channel protein 2 (Q9WUJ9)

Variants

No data

Financial

Revenue by drug

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Prilosec – AstraZeneca

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Estimated US medical usage

Omeprazole

Amoxicillin

Clarithromycin

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Omeprazole

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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158,352 adverse events reported

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