List of Excipients in Branded Drug ALLEGRA-D

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
A-S Medication Solutions	ALLEGRA-D	fexofenadine hydrochloride and pseudoephedrine hydrochloride	50090-1203	CARNAUBA WAX
A-S Medication Solutions	ALLEGRA-D	fexofenadine hydrochloride and pseudoephedrine hydrochloride	50090-1203	CELLULOSE, MICROCRYSTALLINE
A-S Medication Solutions	ALLEGRA-D	fexofenadine hydrochloride and pseudoephedrine hydrochloride	50090-1203	CROSCARMELLOSE SODIUM

ALLEGRA-D Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 6, 2026

ALLEGRA-D is an immediate-release fexofenadine component combined with extended-release pseudoephedrine hydrochloride. Its commercial value depends less on active-ingredient exclusivity than on controlled-release performance, tablet manufacturability, OTC compliance, supply reliability, and access to pseudoephedrine distribution channels. The core formulation is mature, and the strongest opportunities are generic substitution, authorized-generic supply, excipient optimization, abuse-resistant packaging, and differentiated delivery formats rather than new-molecule patent protection.

What is ALLEGRA-D and how is it formulated?

ALLEGRA-D combines:

Product	Fexofenadine HCl	Pseudoephedrine HCl	Release profile
ALLEGRA-D 12 Hour	60 mg	120 mg	Fexofenadine immediate release; pseudoephedrine extended release
ALLEGRA-D 24 Hour	180 mg	240 mg	Fexofenadine immediate release; pseudoephedrine extended release

The products are oral tablets used for temporary relief of allergy symptoms with nasal congestion. Fexofenadine is the antihistamine component. Pseudoephedrine is the systemic nasal decongestant component.[1,2]

The formulation challenge is asymmetric. Fexofenadine must dissolve promptly, while pseudoephedrine must release over approximately 12 or 24 hours. A generic manufacturer therefore must reproduce the combined dissolution behavior, not simply match the total drug content.

What excipients are used in ALLEGRA-D?

US labeling identifies excipient classes including:

• Microcrystalline cellulose
• Lactose monohydrate
• Croscarmellose sodium
• Crospovidone
• Sodium starch glycolate
• Povidone
• Hypromellose
• Colloidal silicon dioxide
• Magnesium stearate

The precise inactive-ingredient list can differ between the 12-hour and 24-hour strengths and between commercial labeling versions. DailyMed labeling should control for product-specific formulation review.[1,2]

These excipients perform distinct functions:

Excipient class	Likely formulation role	Commercial relevance
Microcrystalline cellulose	Diluent and compression aid	Supports tablet hardness and scale-up
Lactose monohydrate	Diluent	Low-cost bulk and acceptable tabletability
Croscarmellose sodium, crospovidone, sodium starch glycolate	Superdisintegrants	Promote rapid fexofenadine release
Hypromellose	Matrix former or film-coating polymer	Controls pseudoephedrine release
Povidone	Binder	Improves granule and tablet strength
Colloidal silicon dioxide	Glidant and moisture-control aid	Improves powder flow
Magnesium stearate	Lubricant	Reduces ejection force but can slow dissolution if overused

How does the ALLEGRA-D excipient strategy control release?

The primary technical strategy is a bilayer or functionally separated release system. The fexofenadine portion is designed for rapid availability, while pseudoephedrine is incorporated into a matrix or controlled-release structure.

Immediate-release fexofenadine layer

The fexofenadine portion requires:

1. Rapid wetting.
2. Tablet breakup.
3. Prompt dissolution.
4. Consistent release across normal gastrointestinal conditions.

Superdisintegrants such as croscarmellose sodium, crospovidone, and sodium starch glycolate can accelerate tablet breakup. Excessive disintegrant, however, can impair tablet strength or increase manufacturing variability.

Lactose and microcrystalline cellulose provide a conventional diluent system. The combination supports compression, but particle-size distribution, moisture, and lubricant exposure must be controlled. Over-lubrication with magnesium stearate can reduce wetting and delay dissolution.

Extended-release pseudoephedrine portion

Pseudoephedrine is present at a high dose, particularly in the 24-hour product. The release-controlling system therefore must accommodate a substantial active load without producing dose dumping.

Hypromellose is a common controlled-release polymer for hydrophilic matrix tablets. On contact with gastrointestinal fluid, the polymer hydrates and forms a gel layer. Drug release then occurs through a combination of diffusion, matrix erosion, and tablet geometry.

A successful substitute must control:

• Polymer viscosity grade
• Polymer concentration
• Drug-to-polymer ratio
• Granule porosity
• Compression force
• Tablet coating permeability
• Hydration and erosion behavior
• Release under varying pH conditions

The main development risk is that a formulation can match a single dissolution condition while failing under agitation, alcohol exposure, fed-state conditions, or prolonged storage.

What excipient changes create the highest technical value?

The strongest excipient opportunities are incremental rather than radical.

Polymer substitution

A manufacturer can evaluate alternative grades of hypromellose or other hydrophilic matrix polymers to reduce cost, improve supply security, or simplify global sourcing. The substitution must preserve the complete dissolution profile.

Reduced-lactose or lactose-free formulations

Lactose reduction can support customers seeking lactose-free products and may reduce dependence on dairy-derived excipients. A direct switch to mannitol, dibasic calcium phosphate, or additional microcrystalline cellulose would require reassessment of compressibility, friability, dissolution, and stability.

Direct compression

Direct compression can reduce processing steps and improve manufacturing economics. It requires excipients with consistent flow and compaction properties. Silicified microcrystalline cellulose or co-processed excipients may reduce segregation risk in a combination tablet.

Moisture and stability optimization

Moisture can alter polymer hydration, tablet hardness, disintegration, and dissolution. Improved packaging, desiccant integration, low-moisture excipients, and tighter humidity controls can provide more commercial value than a new excipient alone.

Taste and swallowability improvements

Because ALLEGRA-D tablets are relatively large and contain a high pseudoephedrine dose, tablet size and swallowability are meaningful product attributes. Film-coating optimization, tablet shape, reduced tablet weight, and alternative multi-unit systems may improve patient acceptance.

What patents protect ALLEGRA-D?

The original active ingredients and basic combination are mature technologies. Fexofenadine and pseudoephedrine are established small molecules, and the principal commercial opportunity is not protected by new-chemical-entity exclusivity.

The relevant historical IP categories include:

• Fexofenadine composition and pharmaceutical-use patents
• Pseudoephedrine controlled-release formulation patents
• Combination-product patents
• Tablet-matrix and release-profile patents
• Manufacturing-process patents
• Method-of-use patents covering allergic rhinitis and congestion

Most foundational rights associated with these actives and early combination products would be expected to have expired or become commercially weak. Current protection, where present, is more likely to involve specific formulations, manufacturing processes, packaging, trademarks, or later product variants.

What is the Orange Book status of ALLEGRA-D?

ALLEGRA-D is an OTC product rather than a conventional prescription product. Its commercial status should not be analyzed solely through the FDA Orange Book, which primarily addresses approved prescription and certain other FDA-listed products with patent and exclusivity information.[3]

For an OTC combination, the relevant regulatory record includes:

• FDA-approved or legacy NDA labeling, where applicable
• FDA OTC monograph requirements
• Drug Facts labeling
• Establishment registration and listing
• State and federal pseudoephedrine controls
• Product-specific labeling and manufacturing records

An Orange Book search alone is not sufficient to identify every formulation, process, trademark, or packaging barrier affecting ALLEGRA-D.

When does ALLEGRA-D lose exclusivity?

ALLEGRA-D has no meaningful remaining new-chemical-entity exclusivity. The practical exclusivity position is defined by the maturity of the ingredients, the availability of competing fexofenadine-pseudoephedrine products, and the absence of a high barrier to developing equivalent OTC products.

The key timing distinction is:

Exclusivity category	ALLEGRA-D relevance
New chemical entity exclusivity	Not commercially relevant
Orphan exclusivity	Not relevant
Biologic exclusivity	Not relevant
Pediatric exclusivity	Not a current commercial barrier
Prescription Hatch-Waxman exclusivity	Limited relevance because the product is OTC
Formulation patent protection	Potentially relevant only for specific surviving claims
Trademark protection	Relevant to branded substitution and packaging
Regulatory compliance	Material ongoing barrier

A competitor can therefore pursue a product with the same active ingredients if it satisfies FDA requirements, demonstrates appropriate quality and performance, and complies with pseudoephedrine controls.

What generic entry risks exist for ALLEGRA-D?

Generic entry risk is high at the active-ingredient level but moderate at the finished-product level.

High-risk areas for the brand

• Low active-ingredient differentiation
• Mature antihistamine and decongestant classes
• Existing competing products such as CLARITIN-D and ZYRTEC-D
• Consumer willingness to switch based on price
• Limited ability to sustain premium pricing without brand loyalty
• Retailer preference for private-label and store-brand products

Barriers facing generic manufacturers

• Reproducing the dual release profile
• Demonstrating dose uniformity in a high-load tablet
• Controlling pseudoephedrine release after storage
• Meeting dissolution specifications across scale
• Managing tablet size and mechanical strength
• Complying with pseudoephedrine sales and tracking rules
• Establishing retail distribution for a controlled-sale OTC product

The biggest technical barrier is not active-ingredient sourcing. It is matching the release behavior of the reference product with a commercially robust process.

Which companies are challenging ALLEGRA-D?

The competitive field includes branded and private-label products containing fexofenadine and pseudoephedrine, as well as products using different antihistamine-decongestant combinations.

Competitor	Antihistamine	Decongestant	Strategic position
CLARITIN-D	Loratadine	Pseudoephedrine	Direct combination competitor
ZYRTEC-D	Cetirizine	Pseudoephedrine	Direct combination competitor
Store-brand fexofenadine-D	Fexofenadine	Pseudoephedrine	Price-based substitution
Store-brand loratadine-D	Loratadine	Pseudoephedrine	Retail private-label competitor
Store-brand cetirizine-D	Cetirizine	Pseudoephedrine	Retail private-label competitor

The closest formulation challenge is a private-label product that matches the dose, duration, tablet count, and consumer instructions of ALLEGRA-D. The closest clinical alternatives are other antihistamine-pseudoephedrine combinations.

What commercial opportunities exist for ALLEGRA-D excipients?

1. Generic and private-label supply

The largest opportunity is supply of excipient systems to generic manufacturers. A supplier that offers a validated extended-release matrix platform can reduce formulation-development time and provide a stronger commercial proposition than a commodity excipient sale.

Potential offerings include:

• Co-processed direct-compression blends
• Controlled-release hypromellose systems
• Low-moisture excipient packages
• Ready-to-use granulation systems
• Lubricant and glidant optimization
• Excipient systems designed for high-dose pseudoephedrine tablets

2. Reformulation for manufacturing efficiency

A reformulation that reduces granulation steps, improves yield, or expands the acceptable compression window can create margin without changing the active ingredients.

Relevant performance metrics include:

• Tablet weight variation
• Compression-force sensitivity
• Friability
• Ejection force
• Dissolution variability
• Manufacturing cycle time
• Yield loss
• Stability failures

3. Smaller or easier-to-swallow dosage forms

A smaller tablet or multiparticulate capsule could address a practical consumer complaint. The main difficulty is preserving the extended-release pseudoephedrine profile while maintaining an immediate-release fexofenadine fraction.

Potential formats include:

• Multiparticulate capsules
• Mini-tablets
• Osmotic or membrane-controlled systems
• Bilayer tablets with reduced overall dimensions
• Film-coated tablets with improved swallowability

These products would require product-specific regulatory and bioequivalence analysis. They may also create new formulation patents if the release architecture is technically distinct.

4. Abuse-resistant packaging

Pseudoephedrine sales are subject to federal purchase limits, identification requirements, recordkeeping, and retailer controls under the Combat Methamphetamine Epidemic Act framework.[4] Packaging does not eliminate these obligations, but secure blister packaging, unit-dose formats, and tamper-evident designs can reduce diversion and improve retailer handling.

Commercial opportunities include:

• Unit-dose blister cards
• Controlled-count cartons
• Tamper-evident seals
• Serialized distribution
• Retailer-integrated inventory controls

Packaging rights may offer more practical differentiation than a narrow excipient patent.

5. Lactose-free and clean-label positioning

A lactose-free version could target consumers who avoid lactose or prefer a simplified excipient profile. The opportunity is commercially plausible but requires careful control of tablet hardness, dissolution, cost, and consumer-facing claims.

Clean-label positioning is more difficult because extended-release products require functional polymers, binders, lubricants, and processing aids. A credible strategy should focus on specific excipient exclusions rather than broad claims about being "natural."

How strong is the ALLEGRA-D patent estate?

The estate is likely weak for the basic product and potentially stronger for narrow formulation or manufacturing claims.

IP category	Relative strength	Commercial assessment
Fexofenadine composition	Low	Mature active ingredient
Pseudoephedrine composition	Low	Long-established active ingredient
Basic combination	Low to moderate	Vulnerable to prior-art attacks
Extended-release matrix	Moderate if claims are narrow	Dependent on dissolution and claim scope
Manufacturing process	Moderate	May create operational rather than market-wide protection
Packaging	Moderate	More useful for channel control than molecule protection
Trademark and trade dress	Moderate	Protects brand presentation, not substitution
Method of use	Low to moderate	OTC allergy and congestion uses are crowded

A new excipient patent would need a defensible technical effect, such as an improved dissolution profile, reduced dose dumping, enhanced stability, smaller tablet size, or improved manufacturing yield. A claim limited to substituting one conventional diluent for another would face significant validity risk.

What FDA regulatory issues affect reformulation?

A new ALLEGRA-D formulation must address both active ingredients and the product’s OTC status. The regulatory pathway depends on whether the product remains within an applicable OTC monograph or relies on an approved application and reference-product framework.

Key issues include:

• Correct active-ingredient strength
• Appropriate Drug Facts labeling
• Demonstrated extended-release performance
• Dissolution testing across relevant conditions
• Stability under accelerated and long-term storage
• Content uniformity
• Impurity and degradation control
• Bioequivalence or comparative performance requirements
• Pseudoephedrine purchase and distribution controls
• Manufacturing under current good manufacturing practice

A formulation change that appears minor from an excipient perspective can materially change drug release. Polymer grade, lubricant level, coating weight, and compression force can each affect regulatory comparability.

Does ALLEGRA-D face biosimilar risk?

No. ALLEGRA-D contains small-molecule active ingredients, not a biologic. Biosimilar regulation under the Public Health Service Act does not apply. The relevant competitive risk is generic or private-label substitution, not biosimilar entry.

What is the revenue exposure of ALLEGRA-D?

Product-level revenue is not generally disclosed separately by the brand owner. Public company reporting typically aggregates ALLEGRA-D within broader consumer-health, allergy, respiratory, or US over-the-counter categories.

Revenue exposure is driven by:

• Seasonal allergy intensity
• Pseudoephedrine availability
• Retailer stocking decisions
• Private-label price competition
• Consumer preference for non-drowsy antihistamines
• State and federal sales restrictions
• Substitution by nasal corticosteroids and other allergy products

The 12-hour and 24-hour products serve different usage occasions. The 24-hour product supports convenience and lower daily dosing frequency. The 12-hour product can offer lower per-dose cost and more flexible timing.

What licensing opportunities exist for ALLEGRA-D excipients?

No single license is required to use standard excipients such as lactose, microcrystalline cellulose, povidone, hypromellose, or magnesium stearate. Licensing opportunities arise when the formulation uses:

• Proprietary co-processed excipients
• Novel controlled-release polymers
• Encapsulation or multiparticulate technology
• Abuse-deterrent delivery systems
• Patented coating systems
• Proprietary manufacturing equipment or process controls

For a generic manufacturer, an excipient license can be attractive when it shortens development time or improves approval probability. The licensing case is weak when the technology merely replaces a readily available conventional excipient without measurable performance improvement.

What generic launch scenarios are most likely?

Scenario 1: Conventional private-label substitution

A manufacturer launches a standard immediate-plus-extended-release tablet using commonly available excipients. This is the most probable and lowest-cost pathway.

Scenario 2: Cost-optimized matrix formulation

The manufacturer uses a co-processed diluent or alternative hypromellose grade to improve production economics. The product competes primarily on price and retailer margin.

Scenario 3: Differentiated dosage form

A smaller tablet, multiparticulate capsule, or improved-swallowability product targets consumers dissatisfied with tablet size. This creates greater formulation and regulatory risk but may support better margins.

Scenario 4: Packaging-led product

The active formulation remains conventional, while unit-dose packaging and retailer controls address pseudoephedrine handling. The value lies in distribution execution rather than formulation exclusivity.

Key Takeaways

• ALLEGRA-D uses a dual-release design: immediate-release fexofenadine and extended-release pseudoephedrine.
• Hypromellose and disintegrant systems are central to release control and manufacturability.
• The foundational active-ingredient and combination-product IP is mature, so basic product exclusivity is weak.
• Orange Book data alone does not define the OTC patent or regulatory position.
• Generic and private-label competition is the primary commercial threat.
• The strongest excipient opportunities involve controlled-release platforms, direct compression, moisture control, lactose reduction, and smaller dosage forms.
• A commercially valuable formulation patent must show a measurable technical advantage, not only a conventional excipient substitution.
• There is no biosimilar risk because ALLEGRA-D is a small-molecule combination product.
• Product-level revenue is not separately disclosed, making market share and retailer access more useful commercial indicators than brand-specific reported sales.

FAQs

Can ALLEGRA-D be reformulated without changing its regulatory status?

A reformulation may remain within the same regulatory framework only if it satisfies applicable OTC, labeling, quality, and performance requirements. Changes to the release-controlling system can trigger additional comparative or bioequivalence requirements.

Which excipient is most important for ALLEGRA-D extended release?

Hypromellose is typically the most important release-controlling excipient because its grade, concentration, and hydration behavior can determine pseudoephedrine release. The full formulation matrix, compression process, and coating system also affect performance.

Is a lactose-free ALLEGRA-D generic commercially viable?

Yes, but the opportunity is primarily consumer and manufacturing differentiation. Replacing lactose requires optimization of tabletability, disintegration, dissolution, stability, and cost.

Can an excipient supplier patent an ALLEGRA-D generic formulation?

Yes, if the formulation contains patentable subject matter such as a novel polymer system, release profile, particle architecture, manufacturing process, or stability improvement. A routine substitution among conventional excipients is less likely to support strong patent claims.

Does pseudoephedrine regulation make ALLEGRA-D difficult to commercialize?

Pseudoephedrine controls complicate distribution, retail sales, inventory management, and packaging. They do not prevent commercialization, but they reduce the attractiveness of uncontrolled e-commerce and make retailer compliance a material competitive factor.

References

1. DailyMed. (n.d.). ALLEGRA-D 12 hour: Fexofenadine hydrochloride and pseudoephedrine hydrochloride extended-release tablets. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

2. DailyMed. (n.d.). ALLEGRA-D 24 hour: Fexofenadine hydrochloride and pseudoephedrine hydrochloride extended-release tablets. U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

3. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

4. U.S. Drug Enforcement Administration. (n.d.). Combat methamphetamine epidemic act requirements for retail distributors and sellers of scheduled listed chemical products. https://www.deadiversion.usdoj.gov/--