List of Excipients in Branded Drug ALLEGRA--D 24 HOUR

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Physicians Total Care Inc	ALLEGRA--D 24 HOUR	fexofenadine hydrochloride and pseudoephedrine hydrochloride	54868-5419	ACETONE
Physicians Total Care Inc	ALLEGRA--D 24 HOUR	fexofenadine hydrochloride and pseudoephedrine hydrochloride	54868-5419	ALUMINUM OXIDE
Physicians Total Care Inc	ALLEGRA--D 24 HOUR	fexofenadine hydrochloride and pseudoephedrine hydrochloride	54868-5419	CELLULOSE ACETATE

Allegra-D 24 Hour Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: September 17, 2026

Allegra-D 24 Hour combines fexofenadine hydrochloride 180 mg with pseudoephedrine hydrochloride 240 mg in an extended-release tablet. Its commercial value comes from the combination of long-acting allergy control and nasal decongestion, not from novel active-ingredient exclusivity. The strongest formulation opportunities are lower-cost extended-release tablets, abuse-deterrent pseudoephedrine presentations, improved swallowability, and private-label products that comply with U.S. behind-the-counter requirements.

The key technical challenge is designing one dosage form that delivers fexofenadine without compromising its absorption while releasing pseudoephedrine over approximately 24 hours. The excipient system must also support tablet hardness, moisture stability, dose uniformity, and manufacturing reproducibility.

What is Allegra-D 24 Hour and how is it formulated?

Allegra-D 24 Hour is an extended-release oral tablet containing:

Component	Strength per tablet	Functional role
Fexofenadine hydrochloride	180 mg	Second-generation H1 antihistamine
Pseudoephedrine hydrochloride	240 mg	Systemic nasal decongestant
Dosage form	Extended-release tablet	Supports once-daily administration

The product is intended for adults and children aged 12 years and older. The fexofenadine component treats allergy symptoms such as sneezing, runny nose, itchy or watery eyes, and itching of the nose or throat. Pseudoephedrine reduces nasal and sinus congestion through vasoconstriction.

FDA labeling identifies an excipient platform that includes common direct-compression and wet-granulation materials, including microcrystalline cellulose, hypromellose, lactose monohydrate, povidone, croscarmellose sodium, sodium starch glycolate, magnesium stearate, crospovidone, and colloidal silicon dioxide. Exact excipient composition and manufacturing conditions should be taken from the current product label and technical dossier rather than inferred from the active ingredients alone. [1]

What release architecture does Allegra-D 24 Hour require?

The product requires differentiated release behavior:

• Fexofenadine must be released rapidly enough to provide antihistamine activity.
• Pseudoephedrine must be released gradually over the dosing interval.
• The system must prevent premature pseudoephedrine dumping after ingestion.
• The tablet must remain stable despite the high pseudoephedrine load.

A matrix-based design using hypromellose is commercially practical. Hydrophilic polymer hydration creates a gel barrier that slows pseudoephedrine diffusion and erosion. Crospovidone, croscarmellose sodium, or sodium starch glycolate can support rapid breakup of the immediate-release fraction, although excessive disintegrant may undermine extended-release control.

What excipients are most important in an Allegra-D 24 Hour generic?

The principal excipient decisions involve the release-controlling polymer, diluent system, disintegrant balance, lubricant level, and coating composition.

Release-controlling polymers

Hypromellose is the most commercially established option for a once-daily pseudoephedrine matrix. Grade selection affects:

• Hydration rate
• Gel strength
• Drug diffusion
• Tablet erosion
• Dissolution sensitivity to agitation
• Performance across fed and fasted conditions

Higher-viscosity hypromellose can reduce dose dumping but may slow release excessively. Lower-viscosity grades can improve release but create greater sensitivity to compression force and tablet porosity.

Alternative polymers include ethylcellulose, ammonio methacrylate copolymers, polyvinyl acetate-based systems, and hydrophilic polymer blends. These alternatives may support a differentiated product, but they increase formulation and regulatory complexity.

Diluent and compression system

Microcrystalline cellulose is useful for compactibility and tablet strength. Lactose can improve powder handling and reduce formulation cost, but lactose-containing systems require control of moisture and may create compatibility or patient-labeling considerations.

Calcium phosphate is another possible diluent for robust direct compression. It can improve hardness but may alter porosity and release behavior. A supplier using a lower-cost formulation should avoid assuming that replacing lactose or microcrystalline cellulose will preserve the reference dissolution profile.

Disintegrants

Croscarmellose sodium, crospovidone, and sodium starch glycolate can be used to accelerate disintegration of the fexofenadine portion. Their performance depends on:

• Particle size
• Swelling capacity
• Intragranular versus extragranular placement
• Compression force
• Polymer concentration

The main risk is a formulation that achieves acceptable early disintegration but produces an undesired pseudoephedrine release profile through excessive water penetration.

Lubricants and glidants

Magnesium stearate improves ejection and reduces tooling problems. Excessive lubrication can reduce tablet tensile strength, delay wetting, and alter dissolution. Colloidal silicon dioxide can improve flow in high-dose powder blends, particularly where pseudoephedrine represents a large proportion of tablet mass.

Film coating

A film coat can provide color, swallowability, moisture protection, and product differentiation. It must not create an unintentional barrier that changes the release profile. A thin, nonfunctional coating is generally easier to defend as a manufacturing choice than a new functional membrane intended to alter drug release.

What formulation patents protect Allegra-D 24 Hour?

The commercial protection for Allegra-D 24 Hour has historically depended more on formulation and combination-product patents than on new chemical entities. Fexofenadine and pseudoephedrine are established active ingredients, and the product’s commercial differentiation rests on their combined use in a once-daily extended-release dosage form.

Potential claim categories include:

Claim category	Typical scope	Commercial relevance
Combination composition	Fexofenadine plus pseudoephedrine	Protects the product concept
Extended-release formulation	Controlled pseudoephedrine release	Main technical barrier
Dosage regimen	Once-daily administration	Supports labeling differentiation
Tablet architecture	Separate or integrated release regions	Can limit design-around options
Manufacturing process	Granulation, compression, coating, or curing	Usually narrower protection
Method of treatment	Treating allergic rhinitis with congestion	May remain relevant where enforceable

The original branded product should not be treated as having current market exclusivity merely because the product name remains commercially active. Patent expiration, terminal disclaimers, ownership transfers, Orange Book listing status, and any later-issued patents must be confirmed against current USPTO and FDA records.

What is the Orange Book status of Allegra-D 24 Hour?

The FDA Orange Book is primarily relevant to approved prescription and certain approved drug applications. Allegra-D products are sold as nonprescription products, and the practical regulatory pathway differs from a conventional prescription NDA with active Paragraph IV litigation.

The absence of an active Orange Book exclusivity position does not eliminate all legal risk. A developer must still evaluate:

• Current or expired patents covering the combination
• Trade dress and trademark rights
• FDA monograph compliance
• Labeling differences
• Manufacturing know-how
• State and federal pseudoephedrine controls
• Potential claims involving a particular controlled-release architecture

When does Allegra-D 24 Hour lose exclusivity?

The active-ingredient exclusivity for Allegra-D 24 Hour is no longer the principal commercial barrier. Fexofenadine and pseudoephedrine have long been marketed, and the underlying active ingredients are available from multiple suppliers.

The relevant expiration analysis has four layers:

1. Chemical-entity patents: Historically important for fexofenadine but no longer a meaningful barrier to a new combination entrant.
2. Combination patents: May have expired or become commercially weak depending on claim scope and jurisdiction.
3. Extended-release formulation patents: The most relevant technical category for an Allegra-D-style product.
4. Regulatory exclusivity: No current brand-like exclusivity should be assumed for a nonprescription combination product without a specific FDA record.

A generic or private-label entrant can therefore pursue a formulation that is pharmaceutically equivalent or sufficiently comparable without copying every excipient or manufacturing step used by the brand.

What Paragraph IV challenges and litigation affect Allegra-D 24 Hour?

Paragraph IV litigation is generally associated with abbreviated new drug applications referencing listed prescription products. Allegra-D 24 Hour presents a different risk profile because it is an OTC combination product with an established nonprescription regulatory history.

The principal legal exposure is more likely to arise from:

• Patent infringement claims directed to extended-release formulation features
• Trademark or trade-dress disputes
• FDA objections to labeling or dosage presentation
• State-law restrictions on pseudoephedrine sales
• Contractual disputes involving private-label manufacturing
• Advertising claims concerning 24-hour duration or symptom superiority

No current, widely material Paragraph IV dispute should be presumed from the product name alone. Litigation searches should distinguish Allegra-D from fexofenadine-only products, pseudoephedrine-only products, and unrelated antihistamine-decongestant combinations.

What generic entry risks exist for Allegra-D 24 Hour?

The generic-entry risk is high at the active-ingredient level and moderate at the formulation level.

High-risk areas for the incumbent

• Generic fexofenadine supply is established.
• Pseudoephedrine hydrochloride is widely available.
• Tablet manufacturing is conventional.
• The combination does not require biologic manufacturing or complex device technology.
• Consumers recognize the active ingredients and can switch based on price.

Moderate-risk areas

• Reproducing 24-hour pseudoephedrine dissolution
• Demonstrating consistent performance after scale-up
• Controlling dose dumping under altered agitation conditions
• Maintaining tablet integrity during shipping
• Managing pseudoephedrine inventory and retail controls

Lower-risk design-around strategies

A competitor may avoid direct copying by using:

• A different hydrophilic polymer grade
• A multilayer tablet
• A coated pellet-in-tablet system
• A separate immediate-release and extended-release compartment
• Different diluents and disintegrants
• A different nonfunctional film coat
• A private-label package using distinct trade dress

The critical regulatory question is whether the alternative product meets the applicable FDA requirements for active ingredients, dosage, labeling, dissolution, and manufacturing quality.

What commercial opportunities exist for new Allegra-D excipient systems?

Lower-cost private-label tablets

Retailers can compete through store-brand extended-release tablets containing the same active ingredients. Cost savings can come from:

• Direct compression
• Reduced excipient count
• Standardized hypromellose grades
• High-speed tablet production
• Contract manufacturing
• Common packaging across multiple retailer brands

The principal commercial constraint is pseudoephedrine distribution and purchaser verification, not active pharmaceutical ingredient access.

Improved swallowability

A large once-daily tablet may create a patient-adherence problem. Opportunities include:

• Lower-friction film coatings
• Modified tablet shape
• Reduced tablet dimensions through higher-density excipients
• Bilayer compression
• Packaging that clearly explains the extended-release design

A smaller tablet cannot be achieved by compression alone if it compromises porosity or release control.

Abuse-deterrent or tamper-resistant presentations

Pseudoephedrine is subject to federal retail restrictions under the Combat Methamphetamine Epidemic Act. A manufacturer could explore packaging that improves inventory control, limits multiple-unit purchases, or provides tamper evidence. These measures would not remove statutory purchase limits, but they could reduce diversion and improve retailer compliance. [2]

Pediatric and geriatric opportunities

The standard product is intended for patients aged 12 years and older. A pediatric product would require separate dose justification and safety evaluation. A geriatric-oriented presentation could focus on swallowability and clearer labeling, but pseudoephedrine-associated cardiovascular and central nervous system effects remain important commercial constraints.

International market expansion

International opportunities are jurisdiction-specific because pseudoephedrine is controlled differently across countries. A formulation strategy may need:

• Country-specific dose strengths
• Alternative decongestants
• Different labeling
• Separate import and distribution controls
• Local patent and trademark clearance

A single global launch is unlikely to be optimal.

How does Allegra-D 24 Hour compare with competing products?

Product type	Antihistamine	Decongestant	Main differentiation
Allegra-D 24 Hour	Fexofenadine	Pseudoephedrine	Once-daily allergy and congestion control
Allegra-D 12 Hour	Fexofenadine	Pseudoephedrine	Twice-daily dosing
Loratadine-pseudoephedrine products	Loratadine	Pseudoephedrine	Alternative antihistamine
Cetirizine-pseudoephedrine products	Cetirizine	Pseudoephedrine	Alternative antihistamine, potentially more sedation
Fexofenadine-only products	Fexofenadine	None	Allergy control without decongestant restrictions
Intranasal steroid products	Various	None	Local anti-inflammatory therapy

Allegra-D 24 Hour has a convenience advantage over 12-hour products but faces substitution from fexofenadine-only products, intranasal corticosteroids, antihistamine-pseudoephedrine combinations, and nonprescription decongestants.

What FDA regulatory issues affect commercial launch?

A U.S. entrant must address both drug regulation and pseudoephedrine controls.

Key requirements include:

• Compliance with the applicable FDA nonprescription drug framework
• Active-ingredient identity, strength, and labeling
• Extended-release dissolution specifications
• cGMP manufacturing
• Stability data
• Tamper-evident packaging where applicable
• Retail sales and purchaser-record requirements
• Monthly purchase limits and identification procedures
• State-specific restrictions

FDA labeling also warns against taking fexofenadine with fruit juice because certain juices can reduce absorption. Aluminum- or magnesium-containing antacids may also reduce fexofenadine exposure when taken close to the dose. These warnings create a labeling and consumer-education issue for any follow-on product. [1]

How strong is the patent estate for Allegra-D 24 Hour?

The estate is commercially weaker than estates for new chemical entities or complex biologics. Its residual strength depends on whether any enforceable claims remain directed to a specific extended-release combination, tablet architecture, or manufacturing process.

Factor	Assessment
Active-ingredient protection	Low
Combination-product protection	Low to moderate, depending on surviving claims
Extended-release formulation protection	Moderate
Manufacturing complexity	Low to moderate
Regulatory substitution risk	Moderate
Pseudoephedrine distribution barrier	Moderate to high
Biosimilar risk	Not applicable

Biosimilar competition does not apply because Allegra-D 24 Hour is a small-molecule drug, not a biologic. The relevant competitive threat is generic, OTC monograph, private-label, and authorized-generic-style substitution.

What is the revenue exposure and market opportunity?

Sanofi does not generally disclose Allegra-D 24 Hour revenue as a separate public reporting line. Product-level revenue therefore cannot be reliably quantified from public corporate filings.

The revenue opportunity is concentrated in:

• Seasonal allergy demand
• Retail pharmacy and mass-market distribution
• Private-label substitution
• Contract manufacturing
• Reformulated once-daily products
• International markets where pseudoephedrine access is permitted

Commercial performance depends heavily on retail placement and supply continuity. Pseudoephedrine purchasing controls can reduce impulse sales and make inventory planning more complex than for fexofenadine-only products.

Key Takeaways

• Allegra-D 24 Hour contains fexofenadine hydrochloride 180 mg and pseudoephedrine hydrochloride 240 mg in an extended-release tablet.
• The main technical barrier is controlling pseudoephedrine release while maintaining rapid and reliable fexofenadine availability.
• Hypromellose, microcrystalline cellulose, lactose, disintegrants, glidants, and magnesium stearate form a commercially practical excipient platform.
• Active-ingredient patent risk is low; formulation and combination claims require targeted clearance.
• The strongest commercial opportunities are private-label products, lower-cost direct-compression tablets, improved-swallowability designs, and controlled-distribution packaging.
• Pseudoephedrine retail restrictions are a greater operational barrier than API availability.
• Biosimilar risk is irrelevant. Generic and OTC substitution are the material competitive risks.
• Product-level Allegra-D revenue is not separately disclosed by Sanofi.

FAQs

Can a manufacturer use the same excipients as Allegra-D 24 Hour?

Yes, excipients are generally not protected merely because they appear in a branded label. The manufacturer must still demonstrate acceptable quality, dissolution, stability, content uniformity, and regulatory compliance.

Is a bilayer tablet commercially viable for fexofenadine and pseudoephedrine?

Yes. A bilayer design can separate rapid fexofenadine release from controlled pseudoephedrine release. It introduces additional compression, layer-weight, cross-contamination, and delamination controls.

Can pseudoephedrine be replaced while preserving the Allegra-D commercial concept?

A replacement decongestant would create a different product and require separate regulatory and clinical evaluation. It would not be a direct Allegra-D equivalent.

Does an Allegra-D generic need to copy the brand’s excipient quantities?

No. It must meet the applicable requirements for active ingredients, dosage form, release performance, labeling, quality, and stability. A different excipient system may be used if it produces an acceptable product.

What is the largest manufacturing risk for a once-daily Allegra-D tablet?

The largest risk is uncontrolled pseudoephedrine release caused by polymer variability, excessive tablet porosity, inadequate process control, or scale-up changes in granulation and compression.

References

1. U.S. Food and Drug Administration. (n.d.). Allegra-D 24 Hour extended-release tablets: Drug facts and prescribing information. Drugs@FDA and DailyMed.

2. U.S. Drug Enforcement Administration. (2024). Retail sales of scheduled listed chemical products and pseudoephedrine purchase limits. U.S. Department of Justice.

3. U.S. Food and Drug Administration. (n.d.). Code of Federal Regulations, Title 21, Part 341: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. U.S. Department of Health and Human Services.

4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.

5. United States Pharmacopeial Convention. (2024). United States Pharmacopeia and National Formulary. USP Convention.