List of Excipients in Branded Drug ALLEGRA D 12 HOUR ALLERGY AND CONGESTION

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Rebel Distributors Corp	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride and pseudoephedrine hydrochloride	21695-931	CARNAUBA WAX
Rebel Distributors Corp	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride and pseudoephedrine hydrochloride	21695-931	CELLULOSE, MICROCRYSTALLINE
Rebel Distributors Corp	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride and pseudoephedrine hydrochloride	21695-931	CROSCARMELLOSE SODIUM
Rebel Distributors Corp	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride and pseudoephedrine hydrochloride	21695-931	HYPROMELLOSES
Rebel Distributors Corp	ALLEGRA D 12 HOUR ALLERGY AND CONGESTION	fexofenadine hydrochloride and pseudoephedrine hydrochloride	21695-931	MAGNESIUM STEARATE

Allegra-D 12 Hour Excipient Strategy and Commercial Opportunities

Last updated: August 10, 2026

Allegra-D 12 Hour combines fexofenadine hydrochloride 60 mg with pseudoephedrine hydrochloride 120 mg in an extended-release oral tablet. Its commercial value is driven less by active-ingredient patent protection than by the difficulty of reproducing a stable, compliant dual-release formulation, navigating pseudoephedrine controls, and achieving reliable consumer substitution. The strongest opportunities are generic extended-release tablets, private-label products, excipient optimization, compliant packaging, and differentiated allergy-congestion delivery systems.

What is Allegra-D 12 Hour and how is it formulated?

Allegra-D 12 Hour is an oral combination product indicated for temporary relief of allergy symptoms and nasal congestion. Each tablet contains:

Component	Amount per tablet	Function
Fexofenadine hydrochloride	Equivalent to 60 mg fexofenadine	Second-generation antihistamine
Pseudoephedrine hydrochloride	120 mg	Nasal decongestant
Dosage form	Extended-release tablet	Sustained pseudoephedrine delivery over approximately 12 hours

The product is marketed as an extended-release tablet rather than as two immediate-release active ingredients. The formulation must deliver rapid antihistamine activity while controlling pseudoephedrine release over the dosing interval. FDA labeling identifies excipients including cellulose-based materials, povidone, disintegrants and lubrication or processing agents. The precise qualitative and quantitative composition is proprietary unless disclosed in regulatory or patent documents. [1]

What excipient functions are required?

The excipient system must support five formulation objectives:

1. Uniform distribution of a relatively low-dose antihistamine.
2. High-dose loading of pseudoephedrine hydrochloride.
3. Controlled release of pseudoephedrine.
4. Tablet mechanical strength during coating, packaging and transport.
5. Adequate disintegration and dissolution after the intended release period.

Typical excipient functions include:

Formulation need	Relevant excipient class	Commercial role
Dilution and compressibility	Microcrystalline cellulose	Supports direct compression and tablet strength
Matrix formation	Hypromellose or another hydrophilic polymer	Controls water penetration and pseudoephedrine diffusion
Binding	Povidone or related binder	Improves granule and tablet cohesion
Disintegration	Crospovidone, croscarmellose sodium or sodium starch glycolate	Promotes breakup of immediate-release regions
Lubrication	Magnesium stearate or equivalent	Supports ejection and high-speed compression
Flow improvement	Colloidal silicon dioxide	Reduces segregation and improves powder flow
Film coating	Hypromellose, titanium dioxide, pigments and plasticizers	Protects the tablet and supports identification

An important development issue is that a conventional disintegrant can conflict with an extended-release matrix. Excessive disintegrant may cause premature release, while insufficient disintegration can delay fexofenadine release and reduce dose uniformity.

How does the Allegra-D 12 Hour release architecture work?

The principal technical challenge is the combination of immediate and extended-release behavior in one tablet. Fexofenadine is generally intended to become available without the prolonged release profile required for pseudoephedrine. Pseudoephedrine must provide sustained decongestant activity while limiting a rapid concentration spike.

Which excipients are most commercially important?

Hydrophilic polymers are the central excipient category. Hypromellose can form a hydrated gel layer around the tablet. The gel controls penetration of gastrointestinal fluid and diffusion of dissolved pseudoephedrine.

Polymer grade is commercially important. Variables include:

• Methoxy and hydroxypropoxy substitution.
• Polymer viscosity.
• Particle size.
• Concentration in the matrix.
• Compression force.
• Tablet porosity.
• Interaction with soluble drug salts.

A generic manufacturer may use a different polymer grade or a different matrix system, but it must demonstrate equivalent release performance. The formulation target is not simply a 12-hour label claim. It includes the full dissolution profile, dose uniformity, tablet integrity, alcohol sensitivity where relevant, and stability under accelerated and long-term conditions.

What are the main excipient compatibility risks?

Pseudoephedrine hydrochloride is a highly water-soluble salt. Highly soluble drugs can diffuse rapidly from hydrophilic matrices unless polymer concentration and tablet geometry are carefully controlled. The principal risks are:

• Initial burst release.
• Excessive sensitivity to compression force.
• Release-rate changes after storage.
• Moisture-driven polymer or tablet changes.
• Segregation between active ingredients and excipients.
• Coating defects caused by tablet expansion or friability.
• Inconsistent release between manufacturing sites.

Fexofenadine hydrochloride also creates formulation constraints because the active ingredients differ in dose, physicochemical properties and intended release behavior. A formulation optimized for pseudoephedrine release may compromise fexofenadine dissolution.

What formulation patents protect Allegra-D 12 Hour?

The current commercial opportunity is not primarily protected by a strong, unexpired patent estate around the original product. Allegra-D 12 Hour was developed from established active ingredients, and the historical exclusivity period associated with the original NDA and formulation patents has largely elapsed.

The commercially relevant protection is more likely to arise from:

• Specific extended-release matrix compositions.
• Bilayer or multilayer tablet architecture.
• Controlled-release coatings.
• Manufacturing processes.
• Particle-size control.
• Stability improvements.
• Abuse-deterrent or tamper-resistant designs.
• Packaging and dispensing systems.
• Combination products using alternative antihistamines or decongestants.

A generic applicant generally faces a formulation equivalence problem rather than a broad composition-of-matter barrier. FDA Orange Book review is necessary for the applicable NDA and any remaining listed patents or exclusivities. [2]

Are there current Orange Book patents for Allegra-D 12 Hour?

Allegra-D 12 Hour is associated with an FDA-approved NDA rather than a new chemical entity with meaningful remaining market exclusivity. The Orange Book is the relevant source for any listed patents, pediatric exclusivity, regulatory exclusivity or reference-product information. Expired historical patents do not prevent ANDA development, although they may remain relevant to patent-history analysis. [2]

The key commercial conclusion is that a potential generic entrant should focus on:

• Paragraph IV exposure for any unexpired listed patent.
• Paragraph III certification where a listed patent remains but launch is delayed.
• Paragraph I or II certifications where applicable.
• Non-patent regulatory requirements for pseudoephedrine distribution.
• Abbreviated new drug application requirements for the extended-release combination.

When does Allegra-D 12 Hour lose exclusivity?

The original active ingredients, fexofenadine and pseudoephedrine, do not provide a meaningful current composition-of-matter exclusivity barrier for Allegra-D 12 Hour. The product's remaining commercial protection, if any, depends on current Orange Book listings and regulatory exclusivity tied to the reference product.

For practical market analysis, the exclusivity timeline is:

Protection category	Current commercial significance
Fexofenadine composition patent	Historical; not a meaningful barrier to current generic entry
Pseudoephedrine composition patent	Historical; not a meaningful barrier
Original combination or formulation patents	Requires current patent-by-patent Orange Book review
NDA exclusivity	Historical for the original reference product
Pediatric exclusivity	Must be confirmed in current FDA records
OTC monograph pathway	Relevant to some ingredients and claims, but the approved combination and extended-release presentation remain product-specific
ANDA pathway	Primary route for a therapeutically equivalent generic

FDA-approved combination products can remain commercially differentiated after patent expiration through brand recognition, retail placement, packaging, and supply reliability.

What Paragraph IV challenges and generic entry risks exist?

A generic applicant could challenge any unexpired listed patent through a Paragraph IV certification. The principal risk is not the active ingredients but the claimed release profile or dosage-form architecture.

Which claims create the greatest litigation risk?

Potentially vulnerable claim categories include:

• Extended-release tablets containing both active ingredients.
• Defined polymer-to-drug ratios.
• Specific dissolution windows.
• Multilayer tablets with separate release zones.
• Coated matrix systems.
• Manufacturing processes that produce a particular release profile.
• Stability claims tied to moisture or temperature control.

A Paragraph IV strategy would require a detailed non-infringement or invalidity analysis. Design-around options could include a different polymer system, a distinct tablet architecture, separate immediate-release and extended-release regions, or an alternative manufacturing process.

What litigation affects Allegra-D 12 Hour?

The principal current market risk is not a known active litigation event but the potential for patent litigation if a generic applicant certifies against an unexpired formulation patent. The product has been commercialized for many years, so litigation risk is likely to depend on the status of any surviving listed patent rather than on the original product launch.

A complete litigation assessment should distinguish:

• Patent cases involving the reference NDA holder.
• Patent cases involving unrelated pseudoephedrine products.
• State or federal cases concerning pseudoephedrine sales.
• Product-liability cases.
• Patent disputes involving different Allegra dosage forms.

These categories do not have the same impact on generic entry.

How does FDA regulate Allegra-D 12 Hour and pseudoephedrine products?

Allegra-D 12 Hour is subject to FDA drug regulation, while pseudoephedrine distribution is also affected by federal controls on retail sales. The Combat Methamphetamine Epidemic Act limits retail sales and requires purchaser identification, quantity controls and recordkeeping for regulated pseudoephedrine products. [3]

State requirements can be stricter. Retailers and manufacturers must account for:

• Behind-the-counter or locked-storage requirements.
• Daily and monthly purchase limits.
• Electronic tracking systems.
• State-specific consumer restrictions.
• Packaging and labeling controls.
• Restrictions on internet or mail-order fulfillment.

These controls increase operating complexity for private-label and e-commerce strategies. They also reduce the attractiveness of unrestricted direct-to-consumer distribution compared with ordinary antihistamine products.

Does the pseudoephedrine component create an abuse-deterrence opportunity?

Pseudoephedrine is regulated because it can be diverted for illicit methamphetamine production. Conventional Allegra-D tablets are not necessarily abuse-deterrent products in the pharmaceutical abuse-deterrence sense. However, manufacturers can pursue operational controls such as:

• Unit-dose packaging.
• Tamper-evident cartons.
• Controlled retailer distribution.
• Serial or lot-level inventory tracking.
• Anti-diversion monitoring.
• Formulation changes that make extraction more difficult.

These measures may improve retailer acceptance and compliance, although they also add cost and may not provide patent protection.

What commercial opportunities exist for Allegra-D excipient suppliers?

The most attractive excipient opportunity is a validated extended-release platform that can support high-solubility salts in combination tablets. Suppliers can create value through formulation performance rather than commodity pricing.

Which excipient platforms have the strongest opportunity?

High-viscosity hypromellose matrices

A high-viscosity hypromellose platform can control pseudoephedrine release and support direct compression or wet granulation. Supplier differentiation depends on lot-to-lot consistency, hydration behavior, particle-size control and regulatory documentation.

Co-processed excipients

Co-processed cellulose, silicified cellulose and disintegrant systems can improve flow, compressibility and tablet robustness. These systems may reduce development time for manufacturers moving from laboratory batches to commercial compression.

Low-moisture excipient systems

Moisture control is important for extended-release tablets. Low-moisture excipients and protective packaging can improve stability and reduce dissolution drift over shelf life.

Functional film coatings

A film coating can improve swallowability, color consistency, product identification and resistance to handling damage. Coatings also offer an opportunity for brand or private-label differentiation without changing the active release mechanism.

Continuous manufacturing inputs

Continuous blending and compression require excipients with predictable flow, bulk density and segregation behavior. Suppliers able to provide narrow material specifications can support continuous or high-speed manufacturing.

What private-label and generic opportunities exist?

The product supports several commercial models:

Opportunity	Market rationale	Main barrier
Authorized generic	Uses established reference formulation or licensing structure	Commercial agreement and supply economics
ANDA generic	Can compete on price and retailer contracts	Bioequivalence and extended-release performance
Store-brand product	High consumer familiarity with allergy and congestion claims	Pseudoephedrine controls and retailer compliance
Regional private label	Can target pharmacy chains and wholesalers	Limited scale and inventory obligations
Dual-tablet alternative	Separates antihistamine and decongestant release functions	Different regulatory and consumer-use profile
Novel controlled-release combination	May improve tolerability or dosing convenience	New clinical and regulatory burden
Excipient platform licensing	Enables multiple controlled-release products	Need for reproducible, transferable performance

The most practical opportunity is a therapeutically equivalent generic or private-label extended-release tablet. A new formulation with a materially different release profile would require a more complex regulatory strategy and may lose the commercial advantage of direct substitution.

How does Allegra-D compare with competing allergy and congestion products?

Product category	Antihistamine	Decongestant	Release profile	Key commercial issue
Allegra-D 12 Hour	Fexofenadine	Pseudoephedrine	Extended-release combination	Strong brand recognition; pseudoephedrine controls
Claritin-D 12 Hour	Loratadine	Pseudoephedrine	Extended-release combination	Direct branded and generic competition
Zyrtec-D 12 Hour	Cetirizine	Pseudoephedrine	Extended-release combination	Sedation perception and established consumer demand
Antihistamine alone	Various	None	Immediate or extended	Avoids pseudoephedrine restrictions
Phenylephrine combination	Various	Phenylephrine	Usually immediate release	Oral phenylephrine effectiveness concerns after FDA review
Separate products	Antihistamine plus decongestant	Separate	Customizable	More dosing flexibility but lower convenience

The closest competitive products are Claritin-D and Zyrtec-D. Their patent estates and generic-entry positions are separate from Allegra-D and should not be treated as interchangeable. Competition is based on symptom relief, perceived sedation, price, retailer access and availability.

What manufacturing and intellectual-property barriers matter most?

Manufacturing barriers

The main manufacturing barriers are technical rather than proprietary:

• Maintaining blend uniformity across two active ingredients.
• Preventing segregation during transfer and compression.
• Controlling tablet porosity and hardness.
• Achieving a reproducible pseudoephedrine dissolution profile.
• Preventing dose dumping.
• Managing coating uniformity.
• Demonstrating stability under moisture and temperature stress.
• Complying with pseudoephedrine inventory and distribution controls.

An established extended-release tablet manufacturer has a meaningful execution advantage because scale-up changes can alter dissolution behavior.

Intellectual-property barriers

The strongest potential IP positions for future products would involve:

• Novel polymer combinations.
• Abuse-deterrent matrices.
• Improved stability at high humidity.
• Reduced tablet size at equivalent dose.
• Multilayer release systems.
• Specific dissolution profiles linked to clinical performance.
• Manufacturing processes that reduce content variability.

A generic version that copies the reference product closely may face greater patent exposure than a deliberately differentiated design. A design-around can reduce patent risk but may increase bioequivalence and development cost.

What revenue exposure does Allegra-D create for manufacturers and retailers?

Allegra-D revenue is exposed to three factors:

1. Seasonal allergy demand.
2. Retail availability of pseudoephedrine.
3. Generic and private-label price erosion.

The product's value is concentrated in spring and summer allergy seasons but remains relevant for perennial allergic rhinitis and nasal congestion. Retailers may prefer private-label products because the active ingredients are mature and consumer demand is established. The limiting factor is inventory management under pseudoephedrine controls, not consumer awareness.

For manufacturers, the product can provide a portfolio anchor for additional allergy products, including:

• Fexofenadine-only tablets.
• Fexofenadine oral suspension.
• Antihistamine nasal sprays.
• Non-pseudoephedrine congestion products.
• Pediatric or lower-dose presentations.
• Seasonal multipacks.

Key Takeaways

• Allegra-D 12 Hour contains fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg in an extended-release tablet.
• The central formulation challenge is immediate antihistamine availability combined with controlled pseudoephedrine release.
• Hypromellose, cellulose-based diluents, binders, disintegrants and lubricants are the key excipient categories.
• Original active-ingredient exclusivity is no longer the primary commercial barrier.
• Generic entry risk depends on any remaining Orange Book-listed formulation patents, ANDA requirements and release-profile equivalence.
• Pseudoephedrine controls create substantial distribution, tracking and retail-compliance obligations.
• The strongest commercial opportunities are generic extended-release tablets, private-label supply, excipient platform licensing and manufacturing optimization.
• Excipient suppliers can differentiate through reproducible polymer performance, low-moisture systems, co-processed materials and continuous-manufacturing compatibility.
• Allegra-D competes most directly with Claritin-D and Zyrtec-D, while non-pseudoephedrine products avoid major regulatory and distribution constraints.

FAQs

Is Allegra-D 12 Hour an extended-release formulation?

Yes. The product combines immediate allergy treatment from fexofenadine with extended delivery of pseudoephedrine in a 12-hour tablet.

Can a manufacturer sell an Allegra-D private-label equivalent?

A manufacturer can pursue a therapeutically equivalent generic or private-label product through the applicable FDA pathway. The product must meet requirements for pharmaceutical equivalence, bioequivalence, manufacturing quality and pseudoephedrine distribution compliance.

Which excipient controls pseudoephedrine release in Allegra-D?

A hydrophilic polymer matrix, commonly based on hypromellose or a similar controlled-release polymer, is the principal mechanism used to regulate release. The exact composition and polymer grade must be confirmed from the applicable product and regulatory records.

Does Allegra-D have biologic or biosimilar competition?

No. Allegra-D contains small-molecule active ingredients. Competition comes from generic drugs and other small-molecule allergy and decongestant products, not biosimilars.

Can an excipient supplier patent a new Allegra-D formulation?

Potentially. Patentable subject matter may include a novel controlled-release matrix, multilayer tablet, abuse-deterrent system, stability improvement or manufacturing process. Patentability depends on novelty, non-obviousness, written description and enforceable claim scope.

References

1. U.S. National Library of Medicine. (n.d.). DailyMed: Allegra-D 12 hour allergy and congestion, fexofenadine hydrochloride and pseudoephedrine hydrochloride tablet, extended release. https://dailymed.nlm.nih.gov/

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

3. U.S. Drug Enforcement Administration. (n.d.). Combat methamphetamine epidemic act requirements for retail sales of pseudoephedrine. https://www.deadiversion.usdoj.gov/partnerships/eme/

4. U.S. Food and Drug Administration. (n.d.). Abbreviated new drug application process and generic drug requirements. https://www.fda.gov/drugs/generic-drugs/abbreviated-new-drug-application-anda-guidance-documents