List of Excipients in Branded Drug EQUATE LANSOPRAZOLE

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Wal-Mart Stores Inc	EQUATE LANSOPRAZOLE	lansoprazole	49035-373	ASCORBIC ACID
Wal-Mart Stores Inc	EQUATE LANSOPRAZOLE	lansoprazole	49035-373	CELLULOSE, MICROCRYSTALLINE
Wal-Mart Stores Inc	EQUATE LANSOPRAZOLE	lansoprazole	49035-373	CETYL ALCOHOL
Wal-Mart Stores Inc	EQUATE LANSOPRAZOLE	lansoprazole	49035-373	COPOVIDONE K25-31

Generic Drugs Containing EQUATE LANSOPRAZOLE

Company	Ingredient	NDC	Excipient
WALMART INC	lansoprazole	79903-068	D&C RED NO. 28
WALMART INC	lansoprazole	79903-068	D&C YELLOW NO. 10
WALMART INC	lansoprazole	79903-068	FD&C BLUE NO. 1
WALMART INC	lansoprazole	79903-068	FD&C RED NO. 40

What are the Most Frequently-Used Excipients in EQUATE LANSOPRAZOLE?

# Of NDCs	Excipient
1	D&C RED NO. 28
1	D&C YELLOW NO. 10
1	FD&C BLUE NO. 1
1	FD&C RED NO. 40

Equate Lansoprazole Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 13, 2026

Equate Lansoprazole is a U.S. private-label over-the-counter proton-pump inhibitor, generally marketed as a 15 mg delayed-release capsule for frequent heartburn. Its commercial value comes from low-cost substitution, Walmart distribution, and established lansoprazole demand rather than from proprietary drug substance or active patent protection.

The core formulation challenge is protecting acid-labile lansoprazole from degradation in the stomach while releasing the drug in the intestine. The principal commercial opportunities are lower-cost enteric systems, lactose-free and gelatin-free presentations, orally disintegrating products, larger-count packages, and combination heartburn products.

What is Equate Lansoprazole?

Equate Lansoprazole is a private-label OTC product containing lansoprazole, typically at a 15 mg strength. It is generally positioned for the short-term treatment of frequent heartburn, defined on OTC labels as heartburn occurring two or more days per week.

The product is not a new chemical entity. Equate is a retail brand, not the drug manufacturer or patent owner. Manufacturing and regulatory responsibility can change by product version, supplier, or packaging contract.

Attribute	Equate Lansoprazole
Active ingredient	Lansoprazole
Drug class	Proton-pump inhibitor
Typical strength	15 mg delayed-release capsule
U.S. route	Oral
Retail category	OTC heartburn treatment
Brand owner	Equate/Walmart private label
Likely regulatory pathway	Approved OTC product supplied under an NDA, ANDA, or private-label arrangement
Primary dosage-form requirement	Delayed intestinal release
Core technical risk	Acid degradation before intestinal absorption
Patent position	Mature generic drug with no meaningful compound-patent barrier

FDA labeling for OTC lansoprazole directs patients to take one capsule before eating for 14 consecutive days. The product is not intended for immediate relief of occasional heartburn because proton-pump inhibition develops over repeated dosing rather than through rapid acid neutralization [1].

What excipients are used in Equate Lansoprazole?

The exact excipient list depends on the manufacturer and product code. Public OTC labels for lansoprazole delayed-release capsules commonly identify excipient classes such as lactose, magnesium carbonate, crospovidone, hypromellose, magnesium stearate, colloidal silicon dioxide, methacrylic acid copolymers, polysorbate 80, talc, titanium dioxide, and capsule-shell materials.

A representative formulation architecture is as follows:

Formulation function	Common excipient or material	Commercial purpose
Drug-core diluent	Lactose monohydrate or similar filler	Provides mass and improves manufacturability
Alkalinizing agent	Magnesium carbonate	Stabilizes lansoprazole against acid-related degradation
Disintegrant	Crospovidone	Promotes dispersion after enteric-coating rupture
Binder or film former	Hypromellose	Supports pellet or granule integrity
Lubricant	Magnesium stearate	Reduces manufacturing friction
Glidant	Colloidal silicon dioxide	Improves powder flow
Enteric polymer	Methacrylic acid copolymer	Prevents release in the stomach
Surfactant	Polysorbate 80	Improves wetting and coating performance
Anti-tacking agent	Talc	Supports pellet coating and processing
Capsule shell	Gelatin or hypromellose	Provides final dosage form
Colorant or opacifier	Titanium dioxide or permitted colorants	Product identification and light protection

These materials should not be treated as proof of the composition of every Equate SKU. Private-label products can change suppliers while retaining the same active ingredient, strength, and labeling. For excipient due diligence, the relevant document is the current package insert or DailyMed entry for the specific national drug code [2].

Why does lansoprazole require an enteric formulation?

Lansoprazole is acid labile. Unprotected lansoprazole can degrade in the stomach before absorption. Commercial products therefore use an enteric-release design, commonly based on drug-containing pellets or granules placed inside a capsule.

A typical multi-layer system has four functional zones:

1. An inert or partially inert core.
2. A drug layer containing lansoprazole and an alkalizing microenvironment.
3. A protective subcoat that limits interaction between the drug layer and the enteric polymer.
4. An enteric coating that resists gastric fluid and dissolves at a higher intestinal pH.

The alkalizing agent is important because lansoprazole stability can be affected by acidic microenvironments. The enteric polymer is equally important because it controls the timing and location of release. Small changes in polymer grade, coating weight, plasticizer concentration, pellet size, or curing conditions can affect dissolution performance.

This technical complexity creates manufacturing barriers even though the drug itself is off patent. A competitor must demonstrate bioequivalence and meet delayed-release dissolution specifications. A cheaper formulation that releases lansoprazole too early can fail both stability and performance testing.

What excipient strategy supports the lowest-cost Equate product?

The likely cost-minimizing strategy is a conventional capsule containing enteric-coated pellets rather than a tablet, orally disintegrating tablet, or liquid product.

The principal cost levers are:

Standardized pellet manufacturing

Fluid-bed or pan coating can produce delayed-release pellets at commercial scale. A standardized pellet process reduces equipment changes and allows the same platform to support multiple private-label customers.

Low-cost enteric polymer selection

Methacrylic acid copolymers are established materials with broad supplier availability. The commercial objective is to minimize polymer loading while maintaining acid resistance, intestinal release, and shelf stability.

Alkaline microenvironment control

Magnesium carbonate or another alkalizing excipient can improve drug stability without requiring a proprietary stabilizer system. The balance is formulation-specific: excessive alkalinity may affect taste, pellet integrity, dissolution, or compatibility with other excipients.

Conventional hard capsules

Gelatin capsules are generally less expensive and easier to source than hypromellose capsules. They are suitable for mass-market products but exclude consumers seeking vegetarian, halal, kosher, or animal-free dosage forms.

Limited color and packaging complexity

A single-strength product with simple capsule identification and high-count packaging reduces conversion, inspection, and inventory costs. Retail private-label products benefit from predictable, low-variance packaging.

What commercial opportunities exist for Equate Lansoprazole?

The largest opportunities are line extensions and supplier differentiation rather than new indications.

Lactose-free lansoprazole

Many conventional lansoprazole capsules use lactose as a filler. A lactose-free formulation could target consumers with lactose intolerance or excipient-avoidance preferences. Replacing lactose with microcrystalline cellulose, mannitol, or another filler would require reassessment of flow, pellet density, dissolution, and capsule fill weight.

The commercial opportunity is credible but limited. Consumers with severe milk-protein allergy may still require careful label review because lactose excipient status and cross-contact controls differ by manufacturer.

Gelatin-free capsules

Hypromellose capsules would support vegetarian and selected religious-dietary markets. The tradeoff is higher capsule cost and possible changes in moisture transmission, fill behavior, and stability.

A private-label supplier could offer a gelatin-free platform across several OTC products, reducing incremental manufacturing cost.

Orally disintegrating and chewable products

An orally disintegrating lansoprazole product could improve administration for patients who have difficulty swallowing capsules. The formulation would still require protection from gastric acid. The commercial challenge is preserving enteric-release performance while avoiding a gritty texture, unpleasant taste, or high manufacturing cost.

Chewable and orally disintegrating systems also create a compliance risk. Consumers may chew or crush a conventional delayed-release product, which can compromise release control. A purpose-designed presentation could address that use case.

Larger-count packages

A 42-count or 84-count package can support planned 14-day courses and improve shelf visibility. Larger packages also increase retailer basket size and reduce packaging cost per dose. The main regulatory issue is maintaining compliant directions that do not encourage prolonged self-treatment beyond the OTC label.

Dual-action heartburn products

A combination of lansoprazole with an immediate-acting antacid could offer both early symptom relief and sustained acid suppression. The formulation must separate the immediate-release and delayed-release functions. A fixed combination would create new regulatory, stability, and labeling work.

The commercial space is more competitive than the single-ingredient category because consumers can choose products combining a proton-pump inhibitor with an antacid or H2-receptor antagonist.

What patents protect lansoprazole formulations?

Lansoprazole’s principal compound and original product patents are expired or no longer constitute a practical barrier to standard generic entry in the United States. The original branded product was Prevacid, marketed by Takeda and its predecessor entities.

The remaining IP risk is more likely to arise from narrow formulation, manufacturing, delivery, or combination claims than from the lansoprazole molecule itself. Potential claim categories include:

• Enteric-coated pellet structures.
• Specific polymer combinations.
• Alkaline stabilizer systems.
• Pellet size distributions.
• Coating thickness or curing parameters.
• Orally disintegrating dosage forms.
• Combination products.
• Manufacturing processes that improve stability or dissolution.

A supplier seeking to launch a materially different product should conduct a current claim search covering U.S. patents, continuations, terminal disclaimers, and Orange Book-listed patents. Patent expiration dates cannot be assigned reliably to an Equate SKU without identifying the underlying approved application and manufacturer.

What is the Orange Book status of Equate Lansoprazole?

The Orange Book generally lists approved applications and patent information by application holder, active ingredient, dosage form, strength, and product code. It does not necessarily identify a product through the retail name "Equate."

For Equate Lansoprazole, the relevant regulatory question is which approved application supports the product and whether the application has any current listed patents or exclusivity. A private-label product may be associated with a contract manufacturer’s application rather than Walmart as the application holder.

Because lansoprazole is an established OTC product, new private-label entry is unlikely to receive meaningful market exclusivity. Standard generic or private-label competition is therefore driven by approval status, supply economics, retailer contracts, and manufacturing reliability.

When does lansoprazole lose exclusivity?

Lansoprazole lost practical market exclusivity years ago. The original U.S. approval occurred in the 1990s, and generic lansoprazole products entered the market after expiration of the relevant branded-drug protections.

Exclusivity element	Status
New chemical entity exclusivity	Expired
Original branded compound protection	Expired
Standard delayed-release generic entry	Established
OTC switch exclusivity	No current meaningful barrier for mature products
Biosimilar exclusivity	Not applicable
Paragraph IV risk	Limited to any later-listed formulation or method patents
Current competitive barrier	Manufacturing, regulatory compliance, supply, and retailer access

Lansoprazole is a small-molecule drug. Biosimilar analysis does not apply. Competitors pursue generic, abbreviated, or OTC approval routes rather than the biologics license application pathway.

Are there Paragraph IV challenges to Equate Lansoprazole?

Paragraph IV litigation is generally directed at patents listed against an approved reference product, not against the Equate retail label itself. A generic applicant may certify that a listed patent is invalid, unenforceable, or will not be infringed. For a mature lansoprazole product, the probability of a new, commercially material Paragraph IV dispute is lower than for a recently approved product.

The principal litigation exposure would arise if a new formulation, combination product, or delivery system relied on an active listed patent. A standard 15 mg delayed-release capsule has limited differentiation and limited incentive for substantial patent litigation.

How strong is the patent estate for Equate Lansoprazole?

The patent estate is weak for the conventional product and potentially moderate for differentiated delivery systems.

Product strategy	Patent strength	Main protection source
Standard 15 mg delayed-release capsule	Low	Manufacturing know-how and regulatory dossier
Lactose-free capsule	Low	Usually difficult to patent broadly
Gelatin-free capsule	Low	Capsule material and formulation claims may be narrow
Orally disintegrating product	Moderate	Dosage-form and release-control claims
Dual-action combination	Moderate to high	Combination, dosing, and formulation claims
Novel pellet coating platform	Moderate	Process and coating architecture claims
New indication	Potentially moderate	Method-of-use claims, subject to validity and label constraints

For Equate, the highest-value assets are likely to be confidential manufacturing parameters, supplier qualification, dissolution control, stability data, and retailer distribution agreements. These assets can be commercially important even when they do not create patent exclusivity.

How does Equate Lansoprazole compare with competing products?

The closest U.S. OTC competitors are store-brand and branded delayed-release proton-pump inhibitors, especially omeprazole and esomeprazole.

Product	Active ingredient	Typical OTC position	Formulation opportunity
Equate Lansoprazole	Lansoprazole 15 mg	Frequent heartburn	Low-cost enteric pellets, lactose-free, capsule alternatives
Generic omeprazole	Omeprazole 20 mg	Frequent heartburn	Strong retail competition and broad supplier base
Nexium 24HR and store-brand esomeprazole	Esomeprazole 20 mg	Frequent heartburn	Premium branding and formulation differentiation
Famotidine products	Famotidine	Faster-acting acid reduction	Immediate relief and combination products
Antacid products	Calcium carbonate, magnesium hydroxide, alginate systems	Rapid symptom relief	High convenience and combination positioning

Lansoprazole can compete on price and established consumer familiarity. It is less differentiated than products with rapid relief claims or combination delivery systems.

What manufacturing and IP barriers affect commercial entry?

The critical barriers are technical and operational.

Acid stability

Lansoprazole requires protection against acidic conditions during processing, storage, and gastric transit. Moisture, heat, and excipient compatibility can affect assay and degradation products.

Enteric-coating reproducibility

Coating uniformity directly affects dissolution. Variability in spray rate, inlet temperature, atomization, polymer solids, and curing can create batch failures.

Bioequivalence

A private-label product must meet the applicable FDA requirements for the regulatory pathway used. Delayed-release products require more than simple active-ingredient matching. Release behavior and systemic exposure must be controlled.

Supply-chain resilience

A low-price retail product is vulnerable to shortages caused by a small supplier base, coating-capacity constraints, or quality holds. Dual sourcing for the active ingredient, enteric polymer, capsule shell, and packaging can protect retail continuity.

Label compliance

OTC labeling must comply with the applicable FDA monograph or approved application. Directions, warnings, duration of use, age restrictions, and claims must remain consistent with the authorized product.

What revenue exposure does Equate Lansoprazole create?

Equate Lansoprazole is likely a low-margin, high-volume retail product. Public financial reporting generally does not disclose revenue by individual Walmart OTC SKU. Revenue exposure therefore depends on unit volume, retail price, retailer margin, supplier transfer price, and shelf availability rather than on patent-protected pricing.

A simplified exposure model is:

Variable	Commercial effect
Higher count per package	Increases revenue per transaction
Lower unit cost	Supports Walmart price leadership
Multi-source supply	Reduces shortage risk
Premium excipient variant	Raises margin but narrows volume
Subscription or repeat purchase	Improves demand predictability
Product recall	Can rapidly eliminate retail revenue
Supplier change	May alter excipient profile and consumer acceptance

The product is commercially attractive for manufacturers with existing OTC coating capacity. It is less attractive as a stand-alone investment in a new facility because standard lansoprazole has limited pricing power.

What licensing deals could support Equate Lansoprazole?

Potential commercial arrangements include:

• Contract manufacturing agreements for delayed-release pellets.
• Private-label supply agreements with Walmart.
• Technology licenses for enteric coating or orally disintegrating delivery.
• Co-development agreements for lactose-free or gelatin-free products.
• API supply agreements with qualified lansoprazole manufacturers.
• Portfolio agreements covering multiple OTC proton-pump inhibitors.

A license for the active molecule is generally unnecessary because lansoprazole is off patent. Licensing value would instead reside in formulation technology, regulatory files, manufacturing processes, or differentiated dosage forms.

Key Takeaways

• Equate Lansoprazole is a mature OTC private-label product, typically containing 15 mg lansoprazole in a delayed-release capsule.
• The formulation depends on an alkalizing drug core and an enteric coating that prevents gastric release.
• Common excipient classes include lactose, magnesium carbonate, crospovidone, hypromellose, magnesium stearate, silica, methacrylic acid copolymers, talc, and capsule-shell materials.
• The active ingredient and standard product concept have no meaningful remaining compound-patent barrier.
• The main entry barriers are dissolution performance, stability, bioequivalence, coating reproducibility, FDA compliance, and supply reliability.
• The strongest commercial opportunities are lactose-free capsules, gelatin-free capsules, orally disintegrating products, larger-count packages, and dual-action heartburn products.
• Biosimilar risk does not apply because lansoprazole is a small molecule.
• Paragraph IV litigation risk is limited for a conventional delayed-release capsule but can arise around later formulation or combination patents.
• The commercial value of Equate Lansoprazole is tied to volume, cost control, Walmart distribution, and uninterrupted supply rather than exclusivity pricing.

FAQs

Is Equate Lansoprazole the same as Prevacid?

It contains the same active ingredient, lansoprazole, but it is a private-label product rather than the Prevacid brand. Inactive ingredients, manufacturer, capsule appearance, packaging, and regulatory application may differ.

Can Equate Lansoprazole capsules be opened?

Product-specific labeling controls this issue. Opening or altering a delayed-release capsule can disturb pellet distribution and enteric protection. Consumers should follow the instructions for the specific package.

Does Equate Lansoprazole contain lactose?

Many lansoprazole delayed-release formulations use lactose, but excipients vary by manufacturer and SKU. The current product label controls the answer for a particular package.

Is there a generic version of Equate Lansoprazole?

Equate Lansoprazole is itself a private-label version of a generic or otherwise approved lansoprazole product. Multiple manufacturers can supply therapeutically equivalent lansoprazole products.

What is the best patent opportunity in lansoprazole?

The strongest opportunity is usually a differentiated delivery system, such as an orally disintegrating enteric formulation, a stable combination product, or a manufacturing process that materially improves stability and dissolution. A standard delayed-release capsule offers limited patent differentiation.

References

1. U.S. Food and Drug Administration. (2024). Lansoprazole delayed-release capsules, 15 mg: Drug facts and directions. FDA OTC labeling database.

2. National Library of Medicine. (2024). DailyMed: Lansoprazole delayed-release capsule. U.S. National Library of Medicine.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA Center for Drug Evaluation and Research.

4. U.S. Food and Drug Administration. (2024). Approved drug products and patent and exclusivity information. FDA Center for Drug Evaluation and Research.

5. Takeda Pharmaceuticals U.S.A., Inc. (2024). Prevacid 24HR labeling and product information..eql