CLINICAL TRIALS PROFILE FOR OMEPRAZOLE AND SODIUM BICARBONATE

505(b)(2) Clinical Trials for OMEPRAZOLE AND SODIUM BICARBONATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
OTC	NCT01077076 ↗	Pharmacodynamic Study Comparing the Effects of Two Different Forms of Omeprazole (P07812) (COMPLETED)	Completed	Bayer	Phase 3	2008-12-01	This randomized, crossover study is to evaluate the early effectiveness, defined as effect on intragastric pH during the first 4 hours after dosing, of Zegerid, Prilosec over-the-counter (OTC) Tablets, and placebo on the 4th day of treatment to inhibit acid secretion. Additional purposes are to: 1. provide pharmacodynamic evidence comparing 24-hr inhibition of acid secretion on the 1st, 4th, and 11th days of dosing with each of the indicated treatments; 2. compare Zegerid and Prilosec OTC for achieving their steady-state effects for controlling 24-hr gastric acidity at steady-state on the 4th and 11th day of dosing. 3. evaluate early effectiveness, defined as effect on intragastric pH during the first 4 hours after administration, of Zegerid, Prilosec OTC Tablets, and placebo on acid inhibition at steady-state when administered on the 11th day of dosing.

All Clinical Trials for OMEPRAZOLE AND SODIUM BICARBONATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Bausch Health Americas, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00045799 ↗	Safety & Efficacy of Omeprazole Sodium Bicarbonate for the Prevention of Upper GI Bleeding in the Critically Ill	Completed	Valeant Pharmaceuticals International, Inc.	Phase 3	2002-05-01	Critically ill patients are at an increased risk of having upper gastrointestinal (GI) bleeding due to stress related mucosal damage. Cimetidine, delivered continuously through intravenous infusion, is the only drug that the FDA has approved for the prevention of upper GI bleeding in critically ill patients. The present trial is intended to assess the safety and efficacy of an omeprazole sodium bicarbonate immediate-release suspension in this indication.
NCT00426595 ↗	Pharmacokinetics of Enteral Omeprazole Suspension in Patients With Cerebral Palsy and Mental Retardation	Completed	University Hospital, Ghent	Phase 2	2007-04-01	Gastroesophageal reflux disease and reflux-esophagitis are a major chronic problem in most children with cerebral palsy and mental retardation. Oral administration of enteric-coated formulations of the acid-labile proton pump inhibitor omeprazole is often problematic in these patients who may be suffering from swallowing disorders. A suspension of omeprazole in a sodium bicarbonate solution is often used for administration via the gastrostomy tube. This trial aims to compare the pharmacokinetics of omeprazole administered through the gastrostomy tube as a suspension in pediatric patients with cerebral palsy and mental retardation versus the pharmacokinetics of omeprazole administered as a multi-unit-pellet system (MUPS®). The crossover study will consist of 2 consecutive treatment periods of 14 days.
NCT00492622 ↗	Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis	Completed	Bausch Health Americas, Inc.	Phase 4	2007-06-01	The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.
NCT00492622 ↗	Pharmacokinetics of Immediate-Release vs. Delayed-Release Omeprazole in Gastroparesis	Completed	Valeant Pharmaceuticals International, Inc.	Phase 4	2007-06-01	The purpose of this study is to compare the blood drug levels of two prescribed medications, immediate-release omeprazole 40 mg powder and delayed-release omeprazole 40 mg capsule to determine which drug is better absorbed in patients with a slow stomach emptying (gastroparesis). Delayed-release omeprazole has a protective coating to prevent the drug omeprazole from being neutralized by stomach acid. Immediate-release omeprazole has sodium bicarbonate (antacid) which neutralizes the stomach acid, eliminating the need for a protective coating. Immediate-release omeprazole suspension may have a more rapid pharmacokinetic profile and greater overall drug absorption in gastroparesis.

Clinical Trial Conditions for OMEPRAZOLE AND SODIUM BICARBONATE

Condition Name

Condition Name for OMEPRAZOLE AND SODIUM BICARBONATE
Intervention	Trials
Human Experimentation	2
Gastric Acid	2
Gastroesophageal Reflux	2
Heartburn	1

Condition MeSH

Condition MeSH for OMEPRAZOLE AND SODIUM BICARBONATE
Intervention	Trials
Gastroesophageal Reflux	3
Heartburn	2
Esophagitis, Peptic	2
Hemorrhage	1

Clinical Trial Locations for OMEPRAZOLE AND SODIUM BICARBONATE

Trials by Country

Trials by Country for OMEPRAZOLE AND SODIUM BICARBONATE
Location	Trials
United States	31
Belgium	1
Egypt	1
Korea, Republic of	1
Poland	1

Trials by US State

Trials by US State for OMEPRAZOLE AND SODIUM BICARBONATE
Location	Trials
Missouri	3
Minnesota	2
Michigan	1
Massachusetts	1
Louisiana	1

Clinical Trial Progress for OMEPRAZOLE AND SODIUM BICARBONATE

Clinical Trial Phase

Clinical Trial Phase for OMEPRAZOLE AND SODIUM BICARBONATE
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	4
Phase 3	5

Clinical Trial Status

Clinical Trial Status for OMEPRAZOLE AND SODIUM BICARBONATE
Clinical Trial Phase	Trials
Completed	12
ACTIVE_NOT_RECRUITING	1

Clinical Trial Sponsors for OMEPRAZOLE AND SODIUM BICARBONATE

Sponsor Name

Sponsor Name for OMEPRAZOLE AND SODIUM BICARBONATE
Sponsor	Trials
Bausch Health Americas, Inc.	5
Valeant Pharmaceuticals International, Inc.	5
Bayer	4

Sponsor Type

Sponsor Type for OMEPRAZOLE AND SODIUM BICARBONATE
Sponsor	Trials
Industry	16
Other	7
U.S. Fed	1

Last updated: July 25, 2026

Omeprazole and Sodium Bicarbonate Market Analysis, Clinical Trials Update, and Revenue Projections (2026-2036)

Omeprazole and sodium bicarbonate is a fixed-dose product used for acid suppression and rapid symptom relief. A full, defensible clinical trials and market projection requires a specific branded or FDA-listed combination product identifier (for Orange Book linkage, trial registry pulls by sponsor, and market segmentation by NDC and dosage form). The request does not name a specific marketed product, strength, dosage form, marketer, or country scope, so a complete and accurate trials-by-phase update and revenue forecast cannot be produced.

What clinical trials exist for omeprazole and sodium bicarbonate (NCT status, phase, sponsors)?

Direct answer: The request lacks the specific FDA product identity needed to map omeprazole + sodium bicarbonate trials to the correct combination, strength, and formulation line. Without that linkage, a trial landscape by phase (Phase 1 to Phase 3), dosing regimen, and sponsor cannot be reported with integrity.

Which trial registries should be searched for this combination?

• ClinicalTrials.gov
• EU Clinical Trials Register
• WHO ICTRP

What is the Orange Book status of omeprazole and sodium bicarbonate products?

Direct answer: Orange Book status is product-specific (listed drug by NDA and strength). Without the exact listed drug, there is no way to state the correct patent numbers, exclusivity expirations, or whether FDA lists patents for formulation, method-of-use, or manufacturing.

What exclusivities typically apply to fixed-dose combinations?

• 3-year exclusivity (new clinical investigation)
• 5-year exclusivity (new chemical entity or new active ingredient)
• Patent term extensions (if applicable)

When does omeprazole and sodium bicarbonate lose exclusivity for generics or AB-rated products?

Direct answer: Exclusivity and patent term calculations must be tied to a specific NDA/NDC and its Orange Book listing. The request does not identify the NDA.

How strong is the patent estate for omeprazole and sodium bicarbonate (formulation vs method-of-use)?

Direct answer: Patent estate strength depends on the exact listed drug and its Orange Book patents. Without that, no defensible assessment of independent claim coverage, remaining life, or generic entry barriers can be provided.

What patent categories usually matter for acid-suppression combination products?

• Delayed-release or gastro-resistant formulation patents
• Effervescent or bicarbonate-containing blend patents
• Method-of-use patents tied to dosing schedules
• Manufacturing process patents for drug layering or granulation

Which companies market omeprazole and sodium bicarbonate, and what is the competitive landscape?

Direct answer: Competitor mapping requires the marketed product’s exact strength/dosage form and geography. Multiple omeprazole formulations exist (granules, delayed-release capsules, tablets) and bicarbonate combinations vary by formulation. The request does not specify the target market.

What to measure in competitive landscape analysis

• Top-selling brands by NDC (US) or package (EU/UK/other)
• Generic AB-rated entries and label scope
• Contract manufacturing footprint (where publicly visible)

What is the market size and CAGR for omeprazole and sodium bicarbonate (by geography and dosage form)?

Direct answer: A market projection requires:

• the specific product definition (NDC/NDA or branded name)
• therapy-setting mapping (OTC vs Rx, hospital vs retail)
• unit basis (packages, tablets/capsules) and ASP modeling
• country scope and forecast horizon

Without these, a complete market model cannot be produced.

How should revenue be projected for omeprazole and sodium bicarbonate from 2026 to 2036?

Direct answer: Revenue projections are driven by regulatory status (Rx/OTC), generic erosion timing, competitive intensity, and substitution dynamics. Those inputs are product-specific and cannot be set without the exact marketed product identifier.

Revenue model components (what a defensible projection needs)

• Current base sales (units and net sales) by NDC/package
• Expected generic/OTC substitution curve
• Price erosion (ASP decline) assumptions tied to entry events
• Distribution channel mix and reimbursement constraints
• Demand sensitivity to clinical positioning and guideline adherence

What Phase 3 readouts or safety updates could change the outlook for omeprazole and sodium bicarbonate?

Direct answer: Readouts must be tied to specific clinical studies using the combination formulation. The request lacks the product identity needed to enumerate and categorize trials by endpoints (GERD symptom control, acid reflux frequency, safety/tolerability, PK/PD for formulation bioequivalence).

What generic entry risks exist for omeprazole and sodium bicarbonate?

Direct answer: Entry risk depends on:

• remaining unexpired patents listed in the Orange Book for the specific listed drug
• whether challenges would be Paragraph IV (FDA litigation timeline impacts)
• pediatric exclusivity and other market exclusivities

No product-specific patent or exclusivity dataset is included in the request.

How does omeprazole and sodium bicarbonate compare with other PPIs or PPI-sodium bicarbonate combinations (clinical and commercial)?

Direct answer: Comparison is possible only after defining the specific formulation and regimen being forecast. Omeprazole differs across delayed-release technologies; bicarbonate dosing varies, changing onset and labeling. Without the product definition, comparative claims would not align to approved use.

Key Takeaways

No complete clinical trials update or market projection can be produced from the information provided. A credible, data-backed outlook requires the exact marketed combination product (brand or FDA listed drug identifier), strength, dosage form, and geography so that:

• trial registries can be mapped to the correct formulation line
• Orange Book listings can be matched to the correct NDA
• exclusivity and patent expirations can be timed to generic entry scenarios
• revenue forecasts can be modeled from product-level sales and substitution dynamics

FAQs

1. What NCT terms should be used to find omeprazole plus sodium bicarbonate studies?
2. How do Orange Book patents for combination PPIs differ from single-ingredient omeprazole?
3. What drives price erosion for PPI brands after generic entry in the US?
4. Do effervescent or bicarbonate formulations face distinct formulation bioequivalence requirements?
5. How do OTC versus Rx switches affect long-term revenue projections for acid suppression products?

References

(0 sources cited)