drug
omeprazole DR
Marketedupdated 3mo agoby Covis Pharmaceuticals Inc (Inactive)
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 8- tagApproval110 co-mentions · 54 sources
- drugOMEPRAZOLE AND SODIUM BICARBONATE63 co-mentions · 57 sources
- drugOMEPRAZOLE63 co-mentions · 57 sources
- drugomeprazole XR-ODT63 co-mentions · 57 sources
- tagSmall Molecule55 co-mentions · 54 sources
- companyDexcel Pharma Ltd27 co-mentions · 27 sources
- drug(omeprazole + sodium bicarbonate)16 co-mentions · 16 sources
- tagRecall5 co-mentions · 3 sources
all catalysts(38)
approval · 38
Dec 4, 2007
approval
OMEPRAZOLE — FDA approval
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Apr 2, 2009
approval
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Sep 21, 2009
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Jul 16, 2010
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Jun 27, 2011
approval
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Apr 9, 2012
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Sep 10, 2012
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Oct 29, 2012
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Aug 16, 2013
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Sep 13, 2013
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Mar 6, 2015
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Mar 30, 2015
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Jun 1, 2015
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Jun 11, 2015
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Aug 7, 2015
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Jan 5, 2016
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Feb 8, 2016
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Feb 10, 2016
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Dec 1, 2016
approval
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Jul 5, 2017
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Oct 30, 2017
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Nov 13, 2017
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Feb 28, 2018
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OMEPRAZOLE — FDA approval
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Jun 12, 2018
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OMEPRAZOLE — FDA approval
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Jul 12, 2018
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Jan 28, 2019
approval
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Apr 8, 2019
approval
OMEPRAZOLE — FDA approval
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Apr 29, 2020
approval
OMEPRAZOLE — FDA approval
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Nov 13, 2020
approval
OMEPRAZOLE — FDA approval
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Jul 7, 2021
approval
OMEPRAZOLE — FDA approval
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Jul 7, 2021
approval
OMEPRAZOLE — FDA approval
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Oct 21, 2021
approval
OMEPRAZOLE — FDA approval
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Sep 30, 2022
approval
OMEPRAZOLE — FDA approval
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Oct 21, 2022
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OMEPRAZOLE — FDA approval
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Nov 8, 2024
approval
OMEPRAZOLE — FDA approval
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Oct 3, 2025
approval
OMEPRAZOLE — FDA approval
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Dec 10, 2025
approval
OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE) — FDA approval
omeprazole DR
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Mar 11, 2026
approval
OMEPRAZOLE — FDA approval
omeprazole DR
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Trials studying omeprazole DR
- phase1A 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
- phase3A 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
- phase1A Multiple Dose Study of LY3502970 in Healthy Participants
- phase1An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates
- phase1A Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects
- phase1Interaction of BI 425809 With Midazolam, Warfarin, Omeprazole and Digoxin
- phase1Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants
- phase1Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Dec 8, 2036
~10.3 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (10)
- Mar 1, 2040method-of-use (U-623)US 11771686
- Jul 16, 2039formulationUS 10751333
- Jul 16, 2039formulationUS 11103492
- Jul 16, 2039formulationUS 11633478
- Jul 16, 2039method-of-use (U-624)US 11911473
- Jul 16, 2039formulationUS 12042539
- Jul 16, 2039formulationUS 12329752
- Jul 16, 2039formulationUS 12440566
- Dec 8, 2036formulationUS 10076494
- Dec 8, 2036formulationUS 10835488
News(1)
- Editor’s Corner: Why an AstraZeneca-Bristol Myers Squibb merger is a bad ideaCombining the two drugmakers would trigger severe regulatory concerns and significant pipeline disruptions, cost numerous jobs, all while damaging the broader biopharma ecosystem and hurting patien…fiercebiotech · 11d ago
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