List of Excipients in Branded Drug KIRKLAND SIGNATURE ALLERCLEAR D 24 HR

Generic Drugs Containing KIRKLAND SIGNATURE ALLERCLEAR D 24 HR

Company	Ingredient	NDC	Excipient
Costco Wholesale Company	loratadine, pseudoephedrine sulfate	63981-138	FERRIC OXIDE RED
Costco Wholesale Company	loratadine, pseudoephedrine sulfate	63981-138	HYPROMELLOSE
Costco Wholesale Company	loratadine, pseudoephedrine sulfate	63981-138	MAGNESIUM STEARATE
Costco Wholesale Company	loratadine, pseudoephedrine sulfate	63981-138	POLYETHYLENE GLYCOL
Costco Wholesale Company	loratadine, pseudoephedrine sulfate	63981-138	PROPYLENE GLYCOL

What are the Most Frequently-Used Excipients in KIRKLAND SIGNATURE ALLERCLEAR D 24 HR?

# Of NDCs	Excipient
1	CALCIUM CARBONATE
1	CELLULOSE, MICROCRYSTALLINE
1	FERRIC OXIDE RED
1	FERROSOFERRIC OXIDE
1	HYDROXYPROPYL CELLULOSE

Kirkland Signature Allerclear D 24 Hour: Excipient Strategy, Patent Position and Commercial Opportunities

Last updated: August 24, 2026

Kirkland Signature Allerclear D 24 Hour is an extended-release combination product containing loratadine, an antihistamine, and pseudoephedrine sulfate, a nasal decongestant. Its commercial value comes from private-label pricing, 24-hour dosing, and consumer recognition of the Allerclear brand. The active ingredients are long off-patent, so the main barriers to competition are formulation performance, regulatory compliance, pseudoephedrine controls, manufacturing scale, and retail distribution.

The strongest excipient opportunities are controlled-release matrix optimization, improved tablet robustness, lower-cost coating systems, excipient simplification, and differentiated packaging. The product is primarily a generic and private-label opportunity rather than a conventional patent-protected innovation.

What is Kirkland Signature Allerclear D 24 Hour?

Kirkland Signature Allerclear D 24 Hour is an oral extended-release tablet for temporary relief of allergy and nasal-congestion symptoms.

Product attribute	Commercial profile
Brand	Kirkland Signature Allerclear D 24 Hour
Retailer	Costco Wholesale
Active ingredients	Loratadine and pseudoephedrine sulfate
Antihistamine dose	Loratadine 10 mg
Decongestant dose	Pseudoephedrine sulfate equivalent to 240 mg pseudoephedrine
Dosage form	Extended-release tablet
Dosing	One tablet every 24 hours
Therapeutic category	Allergy, antihistamine, nasal decongestant
Regulatory category	OTC drug product
Primary competition	Claritin-D 24 Hour and generic loratadine-pseudoephedrine extended-release tablets
Biosimilar relevance	None
Prescription conversion opportunity	Limited, because both active ingredients are established OTC products

The product combines a rapid or controlled antihistamine effect with prolonged pseudoephedrine release. The formulation must maintain drug release over approximately 24 hours while preventing excessive early exposure, tablet failure, and pseudoephedrine dose dumping.

What excipients are used in Allerclear D 24 Hour?

The exact inactive-ingredient profile should be taken from the current package insert or DailyMed record for the specific Kirkland product and manufacturing version. Private-label OTC products can change manufacturers, tablet coatings, colorants, and processing aids without changing the active ingredients.

Typical excipient functions for this product class include:

Excipient function	Likely formulation role
Microcrystalline cellulose or similar filler	Tablet mass, compactability, and mechanical strength
Pregelatinized starch or other binder	Granulation and tablet cohesion
Croscarmellose sodium or sodium starch glycolate	Disintegration control for the immediate-release component
Hypromellose or comparable polymer	Extended-release matrix or film coating
Magnesium stearate	Lubrication during compression
Colloidal silicon dioxide	Flow improvement and moisture management
Povidone	Binder or coating aid
Talc	Anti-adherent and coating processing aid
Titanium dioxide and approved colorants	Tablet identification and appearance
Waxes or coating polymers	Surface protection and release control

The formulation challenge is the coexistence of two release requirements. Loratadine needs adequate availability for allergy control, while pseudoephedrine must release gradually across the dosing interval. A formulation designed only for rapid disintegration may produce excessive pseudoephedrine release. A formulation designed only for strong matrix control may delay loratadine availability or create variable absorption.

How does the extended-release excipient strategy work?

The commercial formulation likely uses a multipart or matrix-based release strategy, although the exact architecture depends on the manufacturer. The principal design options are:

Hydrophilic polymer matrix

Hypromellose and related polymers hydrate after ingestion and form a gel layer. Drug diffusion and matrix erosion then control pseudoephedrine release.

Advantages include:

• Low manufacturing complexity
• Broad supplier availability
• Compatibility with direct compression or wet granulation
• Scalable release adjustment through polymer grade and concentration

Risks include sensitivity to polymer substitution, tablet hardness, compression force, particle size, and gastrointestinal conditions.

Coated or embedded drug particles

Pseudoephedrine particles can be coated with a polymeric membrane or embedded in a controlled-release matrix. The coating thickness and permeability determine the release rate.

This approach can provide tighter release control but creates more process steps and greater sensitivity to coating uniformity. It also creates manufacturing know-how that may be more difficult for a competitor to replicate consistently.

Bilayer or compartmentalized tablet

A tablet may separate the antihistamine and decongestant components physically. One portion can support rapid loratadine release, while a second portion controls pseudoephedrine release.

Bilayer technology can reduce component incompatibility and improve release design. It requires specialized compression equipment and tighter weight-control systems.

Film coating and identification layer

The film coating protects the tablet, controls appearance, improves swallowability, and supports product identification. It usually has limited effect on the principal 24-hour release profile unless the coating is intentionally functional.

A commercial reformulation could use a color-free or lower-pigment coating to reduce regulatory and supply-chain exposure. The tradeoff is reduced visual differentiation and possible packaging changes.

What patent protection covers Allerclear D 24 Hour?

The original active-ingredient patents for loratadine and pseudoephedrine are expired. Loratadine was developed and commercialized decades ago, and pseudoephedrine has been used in OTC products for many years. The commercial product therefore does not depend on current composition-of-matter exclusivity.

Protection category	Current commercial significance
Loratadine composition patent	Expired
Pseudoephedrine composition patent	Expired or otherwise unavailable as a meaningful barrier to entry
Original Claritin brand patents	Expired for practical generic-entry purposes
24-hour formulation patents	Historical patents may have expired; current relevance depends on specific claims and jurisdictions
Manufacturing process patents	Possible but product-specific and difficult to assess without a live patent search
Method-of-use patents	Limited value for a long-established OTC indication
Trade dress and trademarks	Brand and packaging protection remain relevant
Manufacturing know-how	Potentially important, especially for release control and scale-up

The most relevant intellectual-property assets are likely to be trade secrets and process know-how rather than blocking patents. These may include:

• Polymer grade and concentration
• Granulation endpoint
• Compression force and tablet hardness
• Coating parameters
• Particle-size control
• In-process dissolution specifications
• Stability controls
• Packaging configurations
• Methods for preventing premature pseudoephedrine release

A competitor can avoid infringement risk by using a different polymer system, manufacturing process, or tablet architecture, provided it meets the applicable regulatory requirements.

What is the Orange Book status of Kirkland Allerclear D 24 Hour?

Kirkland Signature Allerclear D 24 Hour is generally positioned as an OTC private-label product rather than a branded NDA product with a commercially meaningful Orange Book patent estate.

The Orange Book is most important for approved NDA and ANDA products and associated patent and exclusivity listings. For OTC products marketed under an applicable monograph or through an abbreviated pathway, the key competitive questions may instead involve:

• Whether the product is legally marketed under the applicable OTC framework
• Whether the product relies on an approved application
• Whether the formulation meets the relevant monograph or application requirements
• Whether a competitor has a pending or approved ANDA
• Whether the competitor must certify against listed patents

The product’s practical exclusivity is therefore driven by retail position, supply, price, compliance, and consumer familiarity rather than an active Orange Book patent listing.

When does Allerclear D 24 Hour lose exclusivity?

The product has no meaningful remaining active-ingredient exclusivity. Generic and private-label competition is legally possible because loratadine and pseudoephedrine are established molecules.

The effective commercial timeline is:

Period	Commercial status
Original launch period	Brand-led market with formulation and trademark differentiation
Post-patent period	Generic extended-release competition becomes possible
Current market	Private-label and generic competition based on price, availability, and retailer access
Future market	Further margin pressure, formulation substitutions, and packaging-led differentiation

Kirkland’s remaining advantage is not statutory exclusivity. Costco can maintain an advantage through purchasing scale, member traffic, private-label pricing, and retailer control.

Which companies compete with Allerclear D 24 Hour?

The principal competitive set includes:

• Bayer’s Claritin-D 24 Hour
• Generic loratadine-pseudoephedrine extended-release tablets
• Retailer-branded allergy and decongestant products
• Stand-alone loratadine products
• Stand-alone pseudoephedrine products
• Intranasal corticosteroids such as fluticasone
• Intranasal antihistamines and decongestant sprays
• Combination cold and allergy products

Claritin-D retains brand recognition, but the product’s price premium creates an opening for Kirkland and other private labels. The most important substitute is not another identical tablet. It is a treatment sequence in which consumers use loratadine alone and add pseudoephedrine only when congestion is severe.

What generic entry risks exist for Allerclear D 24 Hour?

Generic entry risk is high because the active ingredients are old, the indication is established, and the dosage form is technically reproducible. The principal barriers are regulatory and operational.

Regulatory equivalence

A competing product must demonstrate appropriate pharmaceutical quality and, where required, bioequivalence. Extended-release products require careful comparison of pharmacokinetic exposure and dissolution behavior.

Pseudoephedrine controls

Pseudoephedrine is subject to federal and state restrictions because it can be diverted for illicit methamphetamine production. Retailers must apply purchase limits, identification controls, sales-record requirements, and storage practices under the Combat Methamphetamine Epidemic Act and related rules. These controls raise operating costs and constrain online distribution. [1]

Manufacturing complexity

The product requires consistent release performance across lots. A low-cost supplier that cannot maintain dissolution specifications may face recalls, retailer delisting, or regulatory action.

Retail access

Costco’s private-label placement is a commercial barrier. A competing manufacturer must obtain shelf space or pharmacy-channel distribution while complying with pseudoephedrine controls.

What formulation patents could protect a new Allerclear-type product?

A new entrant could pursue patent protection for a genuine formulation or manufacturing improvement. Potential claim areas include:

1. A defined hydrophilic polymer matrix that maintains pseudoephedrine release over a specified interval.
2. A multiparticulate system combining immediate-release loratadine and controlled-release pseudoephedrine.
3. A tablet architecture that reduces alcohol-induced or pH-induced dose dumping.
4. A low-moisture process that improves loratadine stability.
5. A reduced-excipient formulation with improved tablet hardness and lower friability.
6. A color-free, allergen-controlled, or lactose-free formulation with comparable dissolution.
7. A manufacturing process that improves content uniformity at commercial scale.
8. A packaging system that limits moisture ingress or tampering.

A patent would need more than a routine substitution of one filler or lubricant for another. The strongest claims would connect a defined excipient composition or process parameter to an unexpected dissolution, stability, bioavailability, or manufacturing result.

How strong is the patent estate for Allerclear D 24 Hour?

The patent estate is weak as a blocking platform and moderate as a formulation-development reference point.

Criterion	Assessment
Active-ingredient protection	Very weak; molecules are long established
Brand protection	Moderate for trademarks and trade dress
Formulation protection	Potentially relevant but likely narrow and product-specific
Manufacturing barriers	Moderate where process know-how is difficult to reproduce
Regulatory barriers	Moderate because extended-release equivalence and pseudoephedrine controls matter
Retail barriers	Stronger for Costco placement than for legal exclusivity
Biosimilar protection	Not applicable

The main diligence risk is assuming that the lack of composition patents means the product is simple to copy. It is legally accessible but operationally more demanding than an immediate-release loratadine tablet.

What excipient commercial opportunities exist?

1. Controlled-release polymer platforms

Excipient suppliers can target hypromellose, polyvinyl alcohol, ethylcellulose, and related polymers for pseudoephedrine matrix systems. The value proposition is reproducible 24-hour dissolution rather than simply lower cost.

2. Direct-compression formulations

A formulation using engineered co-processed excipients could reduce wet-granulation steps, shorten manufacturing time, and improve content uniformity. The opportunity is strongest for manufacturers serving private-label customers with high-volume seasonal demand.

3. Color-free and allergen-controlled products

Consumer demand for simpler labels creates an opportunity for:

• Titanium-dioxide-free coatings
• Dye-free tablets
• Lactose-free products
• Gluten-free positioning where supported by manufacturing controls
• Lower-excipient formulations
• Reduced artificial-color systems

These changes require confirmation that dissolution, stability, appearance, and identification remain acceptable.

4. Tablet robustness

Large extended-release tablets can have swallowing and mechanical-strength problems. Excipient systems that improve hardness without slowing release may support a smaller tablet or a thinner coating.

5. Moisture and stability control

Packaging and excipient systems that reduce moisture sensitivity can extend shelf life and lower inventory losses. High-barrier bottles, desiccant systems, and moisture-resistant coatings are practical development targets.

6. Abuse and tamper resistance

Pseudoephedrine products face diversion concerns. Tamper-evident packaging, transaction controls, and formulation designs that limit crushing or rapid extraction could improve retailer acceptance. The commercial benefit is operational and compliance-related, not necessarily patent-based.

What licensing deals are relevant to Allerclear D 24 Hour?

The product is a private-label OTC medicine, so licensing opportunities are more likely to involve supply and technology agreements than molecule licenses.

Potential deal structures include:

Deal type	Commercial purpose
Contract manufacturing agreement	Supply Costco or another retailer at defined volume and cost
Formulation license	Transfer a controlled-release platform
Excipient supply agreement	Secure polymer, coating, or direct-compression excipients
Private-label development agreement	Create retailer-specific packaging and specifications
Dual-source agreement	Reduce dependence on one manufacturer
Process technology license	Transfer coating, granulation, or matrix-manufacturing know-how
Packaging license	Implement tamper-evident or moisture-protective systems

Public product-level licensing terms and revenue allocations are generally not reported. Costco reports broader merchandise and membership results rather than sales for individual Kirkland OTC products. [2]

What generic launch scenarios are most likely?

Scenario 1: Price-led generic substitution

A manufacturer launches a bioequivalent extended-release tablet and competes through pharmacy and mass-retail channels. This is the most direct risk to branded Claritin-D and other private labels.

Scenario 2: Retailer private-label expansion

A retailer adds a lower-cost loratadine-pseudoephedrine product or switches suppliers. The key selection criteria are landed cost, fill-rate reliability, regulatory history, and pseudoephedrine compliance.

Scenario 3: Formulation differentiation

A supplier offers a smaller tablet, dye-free coating, lactose-free formulation, or improved packaging. These changes can support a premium only if consumers or retailers value the attribute.

Scenario 4: Ingredient substitution

Consumers use loratadine alone, pseudoephedrine alone, or a nasal corticosteroid. This scenario limits the long-term growth of fixed-dose combination products even when direct generic competition is stable.

What regulatory status applies to the product?

The product is an OTC allergy and decongestant medicine. Loratadine is an H1 antihistamine, while pseudoephedrine is a sympathomimetic nasal decongestant. FDA labeling requires warnings relating to hypertension, cardiovascular disease, thyroid disease, diabetes, glaucoma, urinary retention, and use with monoamine oxidase inhibitors, among other conditions. [3]

Pseudoephedrine creates a separate compliance burden. Sales are subject to federal purchase limits and recordkeeping requirements. State-level restrictions can be stricter, and retailer policies may limit quantity, channel, or fulfillment method. [1]

How does Allerclear D 24 Hour compare with Claritin-D 24 Hour?

Factor	Kirkland Allerclear D 24 Hour	Claritin-D 24 Hour
Active ingredients	Loratadine plus pseudoephedrine	Loratadine plus pseudoephedrine
Dosing	24-hour extended release	24-hour extended release
Primary advantage	Lower private-label price and Costco access	Brand recognition and established consumer demand
Patent advantage	No meaningful active-ingredient advantage	Historical formulation and brand assets; limited current blocking value
Retail model	Membership warehouse and private label	Broad pharmacy and retail distribution
Excipient opportunity	Reformulation, cost reduction, supply optimization	Brand-preserving reformulation and lifecycle management
Main risk	Supplier disruption and formulation equivalence	Generic and private-label price erosion

The products compete primarily on price, availability, consumer trust, and perceived equivalence. The active ingredients do not provide durable differentiation.

What geographic coverage and manufacturing barriers matter?

The United States is the core market because pseudoephedrine controls and the Allerclear private-label brand are U.S.-oriented. International expansion is constrained by differences in:

• Pseudoephedrine scheduling
• OTC versus prescription status
• Combination-product rules
• Acceptable excipients
• Labeling requirements
• Import controls
• Bioequivalence standards
• Trademark ownership

Manufacturing barriers include controlled-substance-related inventory controls, validated extended-release processing, dissolution testing, supplier qualification, and capacity planning for seasonal allergy demand. A dual-source strategy is commercially attractive but can create comparability work when changing excipients or manufacturing sites.

Key Takeaways

• Kirkland Signature Allerclear D 24 Hour contains loratadine and extended-release pseudoephedrine sulfate.
• The active ingredients are long off-patent, so the product has little meaningful composition-of-matter exclusivity.
• The most defensible know-how concerns release control, tablet manufacture, dissolution performance, stability, and packaging.
• The strongest excipient opportunities involve hydrophilic matrices, direct compression, robust coatings, lower-moisture systems, and color-free or allergen-controlled formulations.
• Generic entry risk is high, but commercial execution is complicated by pseudoephedrine controls and extended-release manufacturing requirements.
• Costco’s main advantage is private-label pricing, retail access, and purchasing scale rather than patent protection.
• Biosimilar risk is irrelevant because the product contains small-molecule active ingredients.
• Product-level revenue exposure is not publicly reported by Costco and must be evaluated through broader Kirkland, OTC, and warehouse-channel performance indicators.

FAQs

Is Allerclear D 24 Hour the same as Claritin-D 24 Hour?

Both products use loratadine and extended-release pseudoephedrine, but inactive ingredients, tablet construction, manufacturer, labeling, and release specifications can differ.

Can a company patent a new loratadine-pseudoephedrine tablet?

Yes. A company may pursue patents for a novel release system, excipient composition, manufacturing process, stability improvement, or abuse-resistant design. A routine excipient substitution is unlikely to support broad claims.

Is pseudoephedrine an ingredient that limits online sales?

Yes. Federal and state controls restrict sales quantity, identification, recordkeeping, storage, and fulfillment. Retailer policies can impose further limits. [1]

Does Allerclear D 24 Hour have biosimilar competition?

No. Biosimilars apply to biological products. Loratadine and pseudoephedrine are chemically synthesized small molecules, so competition comes from generic and private-label products.

What is the best excipient innovation for a competing product?

A controlled-release polymer system that delivers consistent 24-hour pseudoephedrine release while maintaining tablet strength, low variability, and scalable manufacturing has the clearest commercial value.

References

1. U.S. Drug Enforcement Administration. (n.d.). Pseudoephedrine and ephedrine consumer protection requirements. U.S. Department of Justice.

2. Costco Wholesale Corporation. (2024). Annual report for fiscal year 2024. Costco Wholesale Corporation.

3. U.S. Food and Drug Administration. (n.d.). DailyMed: Loratadine and pseudoephedrine sulfate extended-release tablet labeling. National Library of Medicine.

4. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

5. U.S. Food and Drug Administration. (2023). Nonprescription drug products and OTC monograph regulatory framework. U.S. Department of Health and Human Services.