Lansoprazole
/ / Lansoprazole, Lansoprazole, Prevacid (lansoprazole) is a small molecule pharmaceutical. Lansoprazole was first approved as Prevacid on 1995-05-10. It is used to treat duodenal ulcer, esophagitis, gastroesophageal reflux, helicobacter infections, and stomach ulcer amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| neoplasms | D009369 |
| digestive system diseases | D004066 |
Trade Name
FDA
EMA
Lansoprazole, Prevacid (discontinued: Lansoprazole, Prevacid)
CombinationsLansoprazole, amoxicillin clarithromycin (discontinued: Lansoprazole, amoxicillin clarithromycin, Prevacid naprapac, Prevpac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lansoprazole
Lansoprazole
+
Naproxen
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| basic care lansoprazole | ANDA | 2025-02-05 |
| berkley and jensen lansoprazole | ANDA | 2025-02-14 |
| careone acid reducer | ANDA | 2025-05-15 |
| caring mill lansoprazole | ANDA | 2021-09-02 |
| dg health lansoprazole | ANDA | 2025-03-04 |
| equaline lansoprazole | ANDA | 2025-02-13 |
| equate lansoprazole | ANDA | 2025-03-14 |
| equate lansoprazole delayed release | ANDA | 2020-05-06 |
| foster and thrive acid reducer | ANDA | 2023-09-14 |
| good neighbor pharmacy lansoprazole | ANDA | 2022-08-08 |
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Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Lansoprazole, Lansoprazole, Dexcel | |||
| 11077055 | 2036-04-21 | 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
— A02BC03: Lansoprazole
— A02BC53: Lansoprazole, combinations
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD02: Lansoprazole, tetracycline and metronidazole
— A02BD03: Lansoprazole, amoxicillin and metronidazole
— A02BD07: Lansoprazole, amoxicillin and clarithromycin
— A02BD09: Lansoprazole, clarithromycin and tinidazole
— A02BD10: Lansoprazole, amoxicillin and levofloxacin
HCPCS
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Clinical
Clinical Trials
309 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 | 6 | 3 | 8 | 4 | 6 | 27 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | 4 | 2 | 11 | 1 | 3 | 21 |
| Esophagitis | D004941 | HP_0100633 | K20 | 1 | 4 | 10 | 1 | 1 | 17 |
| Heartburn | D006356 | — | R12 | 1 | 1 | 2 | 1 | — | 5 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | — | — | 1 | 1 | 2 |
| Laryngopharyngeal reflux | D057045 | EFO_1001355 | — | — | — | — | 1 | 1 | 2 |
| Hypertrophy | D006984 | EFO_0002460 | — | — | — | — | 1 | — | 1 |
| Endocrine gland neoplasms | D004701 | EFO_0003769 | D35 | — | — | — | 1 | — | 1 |
| Gastrinoma | D015408 | — | — | — | — | — | 1 | — | 1 |
| Zollinger-ellison syndrome | D015043 | — | E16.4 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ulcer | D014456 | MPATH_579 | — | — | — | 11 | — | 3 | 14 |
| Duodenal ulcer | D004381 | EFO_0004607 | K26 | — | — | 8 | — | 3 | 11 |
| Stomach ulcer | D013276 | — | K25 | — | — | 8 | — | 1 | 9 |
| Gout | D006073 | EFO_0004274 | M10 | — | 1 | 1 | — | — | 2 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 1 | — | — | 1 |
| Peptic ulcer | D010437 | — | K27 | — | — | 1 | — | — | 1 |
| Helicobacter infections | D016481 | EFO_1000961 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Recurrence | D012008 | — | — | — | 1 | — | — | 2 | 3 |
| Renal insufficiency | D051437 | — | N19 | — | 1 | — | — | — | 1 |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | — | 1 | — | — | — | 1 |
| Metaplasia | D008679 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | 1 | — | — | — | 1 | 2 |
| Homeostasis | D006706 | — | — | 1 | — | — | — | — | 1 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | — | — | — | — | 1 | 1 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | — | — | — | 1 | 1 |
| Obstructive lung diseases | D008173 | — | — | — | — | — | — | 1 | 1 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | — | — | — | 1 | 1 |
| Asthma | D001249 | EFO_0000270 | J45 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lansoprazole |
| INN | lansoprazole |
| Description | Lansoprazole is a member of benzimidazoles, a member of pyridines and a sulfoxide. It has a role as an EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor and an anti-ulcer drug. |
| Classification | Small molecule |
| Drug class | antiulcer agents (benzimidazole derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | Cc1c(OCC(F)(F)F)ccnc1C[S+]([O-])c1nc2ccccc2[nH]1 |
Identifiers
| PDB | — |
| CAS-ID | 103577-45-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL480 |
| ChEBI ID | 6375 |
| PubChem CID | 3883 |
| DrugBank | DB00448 |
| UNII ID | 0K5C5T2QPG (ChemIDplus, GSRS) |
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Estimated US medical usage
Lansoprazole
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Amoxicillin
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Clarithromycin
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Lansoprazole
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Lansoprazole
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Naproxen
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Safety
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Adverse Events
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76,344 adverse events reported
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