List of Excipients in Branded Drug GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE

Generic Drugs Containing GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE

Company	Ingredient	NDC	Excipient
L Perrigo Company	omeprazole, sodium bicarbonate	0113-0058	FD&C BLUE NO. 1
L Perrigo Company	omeprazole, sodium bicarbonate	0113-0058	FD&C BLUE NO. 2
L Perrigo Company	omeprazole, sodium bicarbonate	0113-0058	FD&C RED NO. 40
L Perrigo Company	omeprazole, sodium bicarbonate	0113-0058	GELATIN
L Perrigo Company	omeprazole, sodium bicarbonate	0113-0058	POLYSORBATE 80

What are the Most Frequently-Used Excipients in GOOD SENSE OMEPRAZOLE AND SODIUM BICARBONATE?

# Of NDCs	Excipient
1	FD&C BLUE NO. 1
1	FD&C BLUE NO. 2
1	FD&C RED NO. 40
1	GELATIN
1	POLYSORBATE 80

Good Sense Omeprazole and Sodium Bicarbonate: Excipient Strategy and Commercial Opportunities

Last updated: August 18, 2026

Good Sense Omeprazole and Sodium Bicarbonate is an OTC immediate-release proton-pump inhibitor combination built around omeprazole 20 mg and sodium bicarbonate 1,100 mg per capsule. Its commercial value comes from formulation engineering rather than new-molecule exclusivity. Sodium bicarbonate protects omeprazole from gastric acid and creates rapid-release positioning without relying on a conventional enteric-coated pellet system. The main opportunities are private-label expansion, capsule-count optimization, manufacturing-cost reduction, and differentiated packaging.

What is Good Sense Omeprazole and Sodium Bicarbonate?

Good Sense is a retail private-label product containing omeprazole and sodium bicarbonate. The product is used for the treatment of frequent heartburn, generally defined on OTC labeling as heartburn occurring two or more days per week.

Attribute	Product profile
Active ingredient	Omeprazole, 20 mg
Buffering agent	Sodium bicarbonate, 1,100 mg
Dosage form	Delayed-release capsule under OTC labeling
Therapeutic class	Proton-pump inhibitor
Primary use	Frequent heartburn
Commercial category	OTC private-label or store-brand acid reducer
Reference product	Zegerid OTC and related omeprazole/sodium bicarbonate products
Biological product risk	None
Primary competitive risk	Generic and private-label substitution

The combination is technically different from standard omeprazole delayed-release capsules. Conventional omeprazole products commonly use enteric-coated pellets or granules. Omeprazole/sodium bicarbonate products use an alkaline microenvironment to reduce acid degradation before absorption.

How does the excipient system protect omeprazole?

The central excipient strategy is chemical stabilization rather than enteric coating alone. Sodium bicarbonate raises the local pH and neutralizes gastric acid. This reduces exposure of omeprazole to the acidic conditions that rapidly degrade the active ingredient.

The formulation has four functional excipient groups:

1. Sodium bicarbonate as the alkalizing and buffering component.
2. Bulking and flow-control excipients for capsule filling.
3. Binder and disintegration aids to control powder behavior and release.
4. Capsule-shell and processing excipients that support manufacturability and product identification.

Public product labeling for omeprazole/sodium bicarbonate capsules identifies excipient classes that can include mannitol, crospovidone, povidone, hypromellose, magnesium stearate, sodium lauryl sulfate, talc, titanium dioxide, and capsule-shell materials. Exact excipient identity and quantity can vary by manufacturer, NDC, strength, and private-label supply arrangement. [1]

Why sodium bicarbonate is commercially important

Sodium bicarbonate performs more than a conventional filler function. It is part of the product's performance mechanism. Its main commercial advantages are:

• It avoids dependence on a separate enteric-coated pellet platform.
• It permits a rapid-release dosage form while protecting omeprazole.
• It is inexpensive and widely available.
• It has a long history of pharmaceutical use.
• It supports multiple capsule strengths and package configurations.

Its disadvantages include a relatively high mass burden. A 1,100 mg sodium bicarbonate load is large compared with the 20 mg omeprazole dose. That affects capsule size, powder density, fill-weight control, shipping volume, and patient acceptability.

What excipients are most important for manufacturing?

Fill-weight and powder-flow control

Sodium bicarbonate has a substantial role in capsule fill weight. Formulators must control particle-size distribution, bulk density, segregation, and moisture exposure. Inadequate flow can produce weight variation and content-uniformity problems, particularly when the active ingredient is present at a low percentage of total fill.

Mannitol can provide bulk and a relatively clean mouthfeel if the formulation is opened or accidentally contacted orally. Microcrystalline cellulose may improve compressibility and powder structure, although its suitability depends on the final capsule-filling process.

Binding and granulation

Povidone can improve cohesion during wet or dry granulation. The choice of grade affects granule strength, dissolution, residual moisture, and filling performance. Excessive binder can slow dispersion and alter the buffering environment.

Crospovidone can improve breakup of the fill mass after administration. The formulation target is rapid dispersion without compromising powder flow or causing segregation between sodium bicarbonate and the low-dose omeprazole component.

Lubrication and antiadherence

Magnesium stearate reduces friction during capsule filling and equipment operation. The level must be controlled because over-lubrication can reduce wetting and slow dissolution.

Talc can assist flow and reduce adherence to processing equipment. It also introduces a need for tight control of particle quality and regulatory specifications.

Capsule-shell selection

Hard gelatin capsules are common for this product class. Hypromellose capsules can provide an alternative for vegetarian positioning, supply-chain diversification, and selected moisture-control strategies.

Capsule-shell selection affects:

• Moisture transmission.
• Mechanical strength.
• Disintegration.
• Printing and color identification.
• Consumer positioning.
• Compatibility with high-load alkaline fills.

The sodium bicarbonate component makes moisture control important. Packaging selection should be treated as part of the formulation strategy, not as a separate commercial decision.

What formulation patents protect omeprazole and sodium bicarbonate products?

The historic patent position for this product class centered on pharmaceutical compositions combining omeprazole with an alkaline compound, particularly sodium bicarbonate. U.S. patents associated with the original Zegerid formulation included US 6,489,346 and US 6,926,907, among other formulation and dosage-form filings. [2][3]

The core formulation patents have reached or passed their ordinary patent terms. Their historical importance was that they protected the combination of:

• Omeprazole.
• A substantial alkaline compound load.
• Immediate-release or rapid-release delivery.
• Protection of omeprazole from gastric acid.
• Specific dosage forms and administration methods.

By 2026, the commercial barrier is therefore less likely to be a basic composition patent. Remaining risks can arise from later patents covering specific manufacturing processes, packaging configurations, dosage regimens, pediatric presentations, or improved formulations. Current Orange Book listings must be reviewed by NDA and product identifier because OTC and prescription products do not necessarily have identical listing histories. [4]

What is the Orange Book status of Good Sense Omeprazole and Sodium Bicarbonate?

Good Sense is an OTC product, so its commercial position should not be analyzed as if it were a conventional prescription NDA with a simple Orange Book patent listing. The FDA Orange Book primarily supports therapeutic-equivalence determinations for approved drug products and includes patent and exclusivity information for applicable listed products. [4]

For this product class, the relevant regulatory questions are:

• Whether the specific Good Sense NDC is marketed under an approved OTC NDA or as a private-label product linked to another approved application.
• Whether the product is an authorized generic or a separate approved product.
• Whether the reference product has unexpired listed patents.
• Whether the product's labeling and formulation match the approved reference.
• Whether any current exclusivity affects abbreviated approval or substitution.

The product's commercial name does not establish patent ownership. The controlling entities may include a private-label marketer, an application holder, a contract manufacturer, and a separate owner of formulation or process rights.

When does omeprazole and sodium bicarbonate lose exclusivity?

The active ingredient omeprazole has long been off-patent. The combination's original formulation protection also has largely expired. Market entry is therefore governed mainly by regulatory approval, manufacturing capability, supply agreements, and retail contracting.

Exclusivity category	Relevance to Good Sense
New chemical entity exclusivity	Expired
Core omeprazole composition patents	Expired
Original omeprazole/sodium bicarbonate formulation patents	Generally expired or at ordinary term end
Pediatric exclusivity	Not a meaningful current barrier for the OTC category
Orphan exclusivity	Not applicable
Biosimilar exclusivity	Not applicable
Retail private-label rights	Contractual, not statutory
Manufacturing know-how	Potentially relevant despite patent expiry

The commercial result is a low statutory barrier and a high execution requirement. A competitor can often use the same active-ingredient concept, but it still must meet stability, dissolution, content-uniformity, packaging, labeling, and supply requirements.

Are there Paragraph IV challenges for Good Sense?

Paragraph IV litigation is more relevant to abbreviated applications that challenge listed patents for an approved reference drug. It is less central to an OTC private-label product once the core formulation patents have expired and multiple products are already marketed.

Potential Paragraph IV issues could involve:

• A newly listed formulation patent.
• A later-developed dosage form.
• A process patent tied to an approved product.
• A specific method of use.
• A patent associated with a reference NDA rather than the Good Sense label itself.

The product does not face biosimilar litigation because omeprazole is a small molecule. Generic entrants would use an ANDA or another applicable FDA pathway, not a biosimilar application under the Public Health Service Act. [5]

What commercial opportunities exist in excipient reformulation?

1. Lower-cost private-label supply

The largest opportunity is cost reduction through optimized powder processing. A supplier can compete by improving:

• Sodium bicarbonate particle-size control.
• Low-dose omeprazole distribution.
• Blend uniformity.
• Capsule-filling speed.
• Yield and rejection rates.
• Moisture-protective packaging.

Because the active ingredients are inexpensive, process efficiency and packaging economics can have a material effect on gross margin.

2. Smaller capsule or reduced pill burden

The 1,100 mg sodium bicarbonate load limits miniaturization. Commercial development could focus on higher-density excipient systems, optimized granulation, or alternative dosage forms that preserve buffering performance with less apparent bulk.

A smaller capsule can improve swallowing and reduce package size. Any reduction in sodium bicarbonate must preserve acid-neutralization capacity and omeprazole stability.

3. Vegetarian and differentiated capsule shells

Hypromellose capsules could support a vegetarian or gelatin-free claim. This is a modest but practical point of differentiation in store-brand portfolios. The change requires evaluation of moisture transmission, shell brittleness, filling performance, and dissolution.

4. Dual-strength and package architecture

Potential line extensions include:

• 10 mg omeprazole/low-dose sodium bicarbonate products.
• 20 mg products in 14-, 28-, 30-, and 42-count formats.
• Three-month supply packages.
• Travel-size blister packs.
• Club-store multipacks.
• Calendarized dosing packs.

The package architecture must align with OTC labeling, which commonly directs once-daily use for a limited treatment period and advises medical consultation for persistent or recurrent symptoms. [1]

5. Stability-focused packaging

Blister packaging, high-barrier bottles, desiccants, and induction seals can protect the alkaline formulation from humidity. Packaging may provide greater practical value than a new excipient because moisture can affect powder flow, capsule performance, and long-term stability.

What manufacturing and intellectual-property barriers remain?

The main barriers are technical and operational:

• Uniform distribution of a low-dose active through a high-mass bicarbonate blend.
• Control of bicarbonate moisture uptake.
• Prevention of segregation during transport and filling.
• Consistent dissolution and buffering performance.
• Capsule-shell compatibility.
• Stability across temperature and humidity zones.
• Validation of cleaning procedures for alkaline powders.
• Reliable supply of pharmaceutical-grade sodium bicarbonate.
• FDA-compliant labeling and OTC quality systems.

Trade secrets can remain commercially important after patent expiration. Examples include blending order, granulation endpoint, lubricant addition time, sieve specifications, environmental controls, and packaging configurations. These measures do not create statutory market exclusivity, but they can reduce manufacturing failures and support supply contracts.

Which companies are challenging the market?

Competition comes from four groups:

1. Branded and authorized-generic Zegerid products.
2. Retail private-label products sold through pharmacies and mass merchants.
3. Standard omeprazole delayed-release capsules.
4. Other OTC acid-reducing products, including famotidine, lansoprazole, esomeprazole, calcium carbonate, and alginate-based products.

Standard omeprazole products compete directly on price but do not replicate the same sodium bicarbonate formulation. Famotidine competes on rapid symptom relief and a different mechanism. Combination products compete on convenience and consumer recognition.

The most credible entrant is a manufacturer with established OTC capsule capacity, validated stability data, and access to national retail distribution. Patent ownership alone is unlikely to determine market success.

What licensing deals affect Good Sense Omeprazole and Sodium Bicarbonate?

The commercial structure may involve a private-label agreement between the retailer, an application holder, and a contract manufacturer. Public product labeling generally identifies the responsible manufacturer or distributor but does not disclose the economic terms of private-label supply contracts.

Potentially important rights include:

• Approved application ownership.
• Use of reference-product data.
• Manufacturing and packaging rights.
• Trademark or store-brand rights.
• Territory-specific distribution rights.
• Formulation know-how.
• Technology-transfer obligations.

No licensing premium should be attributed to the basic omeprazole/sodium bicarbonate concept without evidence of an active patent, proprietary manufacturing process, or exclusive regulatory position.

What generic launch risks exist?

A generic or private-label launch would face low patent risk but meaningful operational risk. The main launch scenarios are:

Scenario	Market effect
Additional low-cost capsule supplier	Retail price pressure
National private-label rollout	Rapid share migration from branded products
Smaller-capsule reformulation	Potential consumer and retailer differentiation
High-barrier packaging upgrade	Better stability and expanded distribution
Standard omeprazole price reduction	Substitution away from the bicarbonate combination
Supply interruption by incumbent	Short-term opportunity for alternate suppliers

Revenue exposure is concentrated in the OTC heartburn category rather than in a protected prescription franchise. Without product-specific sales data, the appropriate commercial metric is retail distribution, unit velocity, gross margin, and retailer shelf placement rather than patent-protected revenue.

Key Takeaways

• Good Sense Omeprazole and Sodium Bicarbonate uses sodium bicarbonate as a functional stabilizer and buffer, not merely as a filler.
• The formulation's core patent barriers have largely expired.
• The product has no biosimilar risk because omeprazole is a small molecule.
• Paragraph IV risk is limited unless later formulation, process, or method-of-use patents apply.
• The strongest commercial opportunities are private-label expansion, process-cost reduction, capsule-size optimization, and moisture-protective packaging.
• Excipient reformulation must preserve buffering capacity, blend uniformity, dissolution, stability, and capsule manufacturability.
• Manufacturing know-how and retailer contracts may matter more than patent ownership.
• The key competitive threat is low-cost private-label substitution from established OTC manufacturers.

FAQs

Can sodium bicarbonate be replaced with another buffer?

Potentially, but replacement would change the product's stability mechanism, fill weight, dissolution profile, labeling basis, and regulatory position. Sodium bicarbonate is commercially attractive because it is inexpensive, familiar, and directly associated with the established formulation concept.

Does a conventional enteric coating create a new commercial product?

It can create a different formulation and regulatory product, but it does not automatically create meaningful exclusivity. A conventional enteric-coated omeprazole product would compete with numerous established generic products.

Is a gelatin-free version commercially viable?

Yes. Hypromellose capsules can support a vegetarian or gelatin-free presentation. The main development issues are moisture transmission, shell performance, filling speed, and stability.

Can the sodium bicarbonate dose be reduced to make a smaller capsule?

A lower dose may be feasible only if the formulation continues to protect omeprazole from acid degradation and meets dissolution and stability requirements. The bicarbonate load is a functional requirement, not a discretionary filler quantity.

Does Good Sense have a protected method of use?

The ordinary OTC heartburn use is unlikely to provide meaningful current exclusivity by itself. Any protection would depend on a specific unexpired patent tied to a defined regimen, population, dosage form, or approved application.

References

1. U.S. Food and Drug Administration. (n.d.). DailyMed: Omeprazole and sodium bicarbonate capsule labeling. National Library of Medicine.
2. U.S. Patent No. 6,489,346. (2002). Pharmaceutical compositions containing omeprazole and bicarbonate.
3. U.S. Patent No. 6,926,907. (2005). Pharmaceutical compositions containing omeprazole and an alkaline compound.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
5. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application process and generic drugs.