TheraRadar
Data updated: May 26, 2026

OMEPRAZOLE

Proton Pump Inhibitors
Gastrointestinal Approved 2002-07-31

OMEPRAZOLE is indicated for the treatment of Heartburn.

Source: FDA Label • GLENMARK PHARMS LTD
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
22
Indications
--
Phase 3 Trials
23
Years on Market

Details

Status
Prescription
First Approved
2002-07-31
Patent Cliff
2036

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, DELAYED REL PELLETS, TABLET, DELAYED RELEASE, TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE

Companies

GLENMARK PHARMS LTD Sun Pharma Novartis Aurobindo Pharma HETERO LABS LTD III BRECKENRIDGE Teva DEXCEL Apotex STRIDES PHARMA XIROMED DEXCEL PHARMA ZYDUS PHARMS USA INC PHARMOBEDIENT Dr. Reddy's Lupin LANNETT CO INC IMPAX LABS
Active Ingredient: OMEPRAZOLE

OMEPRAZOLE Approval History

2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
623 FDA actions from 2002 to 2026
Apr 2026 SUPPL
Mfg · Manufacturing (CMC)
Mar 2026 SUPPL
Label · Labeling
FDA Letter Label
Oct 2025 SUPPL
Mfg · Manufacturing (CMC)
FDA Letter Label

What OMEPRAZOLE Treats

1 indications

OMEPRAZOLE is approved for 1 conditions since its original approval in 2002. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Heartburn
Source: FDA Label

OMEPRAZOLE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE
Baxter
2024 4 indic.
TECHNETIUM TC-99M SULFUR COLLOID KIT
JUBILANT
2023 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to OMEPRAZOLE

3 of 6

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
BISMUTH SUBSALICYLATE
1 shared
AILEX PHARMS LLC
Shared indications:
Heartburn
DEXILANT
DEXLANSOPRAZOLE
1 shared
Takeda
Shared indications:
Heartburn
DEXLANSOPRAZOLE
DEXLANSOPRAZOLE
1 shared
Viatris
Shared indications:
Heartburn
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Clinical Trial Registry

154 trials
Trial Sponsor ID Phase Status Title
NCT05646862 INAVO121 WO43919 2022-502322-41-00 Ph 3 active not recruiting A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
NCT07214662 GO46057 Ph 1 recruiting A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
NCT06686628 INT18404 U1111-1303-3406, 2024-513495-17 Ph 1 completed An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates
NCT02783040 results posted 1346.22 2015-001371-41 Ph 1 completed Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin
NCT07223671 CA127-1088 Ph 1 completed Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
NCT06562907 GS-US-506-6610 Ph 1 recruiting Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
NCT07235748 S095032-230 Ph 1 completed Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants
NCT05444556 results posted 18413 J2J-MC-JZLI Ph 1 completed A Study of Imlunestrant (LY3484356) in Female Healthy Participants
NCT04840888 results posted 18204 J2J-MC-JZLD Ph 1 completed A Study of LY3484356 in Healthy Female Participants
NCT02950259 results posted 16-126B IRX-2 2016-B Ph 1 completed Pre-operative IRX-2 in Early Stage Breast Cancer (ESBC)
NCT06494761 results posted 1479-0014 2023-510263-35-00, U1111-1301-9035 Ph 1 completed A Study in Healthy Men to Test Whether Zongertinib Affects How 3 Other Medicines (Midazolam, Omeprazole, and Repaglinide) Are Taken up and Processed by the Body
NCT07156201 ABS1230-1001 Ph 1 recruiting A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ABS-1230 Given Orally Compared With Placebo in Healthy Participants Aged 18 to 55 Years
NCT07149415 296HV104 Ph 1 completed A Study to Learn if Taking BIIB141 (Omaveloxolone) Affects How Omeprazole is Processed in the Body and About BIIB141's Safety in Healthy Adults Aged 18 to 55
NCT05468164 results posted 17752 J2G-MC-JZJQ, LOXO-RET-18015 Ph 1 completed A Study of Effect of Food and a Proton Pump Inhibitor on Selpercatinib (LY3527723) in Healthy Participants
NCT05680870 MS.22.12.2244.R1 Ph 3 completed The Possible Protective Role of Omeprazole Against Oxaliplatin Induced Neuropathy in Cancer Patients
NCT06383338 PEGASUS PEGASUS 2023/ETH01954 Ph 1 recruiting A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.
NCT06948006 D9441C00003 Ph 1 completed A Study to Investigate the Relative Bioavailability of 2 Different Formulations of AZD4144, the Effect of Food and Omeprazole on the Pharmacokinetics of AZD4144 in Healthy Participants
NCT06605950 CN012-0030 Ph 1 completed A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants
NCT05487235 GO43712 2021-006479-40 Ph 1 completed A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors
NCT07037888 Keto 16671 Ph 4 recruiting Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy: A Prospective Double-Blinded Randomized Controlled Trial
NCT06279234 C4001002 NCT06279234 Ph 1 completed A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus
NCT03267680 results posted 5GYN-16-2 NCI-2017-01402, 5GYN-16-2 Ph 2 terminated IRX-2 Regimen in Treating Women With Cervical Squamous Intraepithelial Neoplasia 3 or Squamous Vulvar Intraepithelial Neoplasia 3
NCT06162169 JAB-21822-1010 Ph 1 completed A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects
NCT05581992 20190320 Ph 1 completed Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
NCT03556592 LP0162-1342 2018-000534-35 Ph 1 completed Drug-drug Interaction Trial With Tralokinumab in Moderate to Severe Atopic Dermatitis - ECZTRA 4
NCT06322706 ABSK021-105 Ph 1 completed A Clinical Trial to Evaluate a High-Fat Meal and Omeprazole Enteric-coated Tablets on ASBK021
NCT06822166 ET-26-HCL-CP-006 Ph 1 completed Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride
NCT02638116 CR108106 2015-005015-32, PCI-32765CLL1005 Ph 1 completed A Drug Interaction Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults
NCT01499368 results posted LAF-BR-CT-302 Ph 3 completed A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess and Compare to the Efficacy and Safety of Lafutidine, Famotidine and Omeprazole-referenced in Korean Erosive Esophagitis Patients
NCT05134350 results posted LOXO-BTK-20014 J2N-OX-JZNH Ph 1 completed Study of the Effect of Food and a Proton Pump Inhibitor (PPI; Omeprazole) on LOXO-305 in Healthy Participants
NCT05599828 20200199 Ph 1 completed A Study to Evaluate the Impact of Acid-reducing Agents on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
NCT05981365 results posted GBT440-0122 C5341029 Ph 1 completed Voxelotor CYP and Transporter Cocktail Interaction Study
NCT05338502 results posted 17574 J2G-OX-JZJL, LOXO-RET-19075 Ph 1 completed Study of H2 Antagonist and a Proton Pump Inhibitor of Selpercatinib in Healthy Participants
NCT03864042 results posted ARRAY-818-103 C4221003, 2019-001036-66 Ph 1 completed Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors
NCT04246762 results posted CL04041026 Ph 1 completed Study in Subjects With Rheumatoid Arthritis to Evaluate the Effect of a Single Dose of Olokizumab on the Pharmacokinetics of Substrates for CYP1A2, CYP2C9, CYP2C19 and CYP3A4
NCT05067439 results posted B7451092 Ph 1 completed A Study to Estimate the Effect of Multiple Dose Abrocitinib on Caffeine, Efavirenz, and Omeprazole in Healthy Participants
NCT06031454 RAY1216-23-05 Ph 1 completed Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin
NCT05635110 VX22-548-013 Ph 1 completed Evaluation of the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Participants
NCT02609386 INSPIRE results posted IRX-2 2015-A Ph 2 completed IRX-2 Regimen in Patients With Newly Diagnosed Stage II, III, or IVA Squamous Cell Carcinoma of the Oral Cavity
NCT05497557 results posted 20220024 Ph 1 completed A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
NCT04028466 RP 19-007 Ph 4 terminated Effectiveness of Vonoprazan vs Omeprazole as Empiric Therapy for Gastroesophageal Reflux Disease (GERD) Patients Without Alarm Features
NCT05932277 CN007-1000 Ph 1 completed A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy Participants
NCT05852769 IM038-022 Ph 1 completed A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
NCT05319912 results posted WTX101-102 CA13895 Ph 1 completed A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults
NCT05319899 results posted WTX101-101 CA12887 Ph 1 completed A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults
NCT03531762 results posted MS200095_0039 2017-002832-18 Ph 1 completed Effect of a Proton Pump Inhibitor on the PK of Tepotinib
NCT03028103 results posted EZH-105 Ph 1 completed Open-Label, Multicenter, Two-Part, Phase 1 Study to Characterize Effects of a Moderate CYP3A Inhibitor on PK of Tazemetostat, Effects of Tazemetostat on PK of CYP2C8 and CYP2C19 Substrates, and Effect of Increased Gastric pH on PK of Tazemetostat in B-cell Lymphoma or Advanced Solid Tumor Patients
NCT02740712 DDI CO-338-044 Ph 1 completed Pharmacokinetic Drug-Drug Interaction Study of Rucaparib
NCT04718181 BP42066 Ph 1 completed Bioavailability and Bioequivalence of Two Risdiplam Tablets in Healthy Participants
NCT02013427 results posted STU00080585 R01AT007987-01A1 Ph 4 completed Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial

Showing 50 of 154 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OMEPRAZOLE FDA Label Details

Indications & Usage

FDA Label (PDF)

OMEPRAZOLE is indicated for the treatment of Heartburn.

View full patent landscape →
2 OB patents · 1 families · 10 international docs across 4 countries

OMEPRAZOLE Patents & Exclusivity

Latest Patent: Dec 2036

Patents (2 active)

US10835488 Expires Dec 8, 2036
US10076494 Expires Dec 8, 2036
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for OMEPRAZOLE

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2036
  • • 2 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 6 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: ANDA091672 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.