List of Excipients in Branded Drug ALLEGRA D-12 HOUR

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Physicians Total Care Inc	ALLEGRA D-12 HOUR	fexofenadine hydrochloride and pseudoephedrine hydrochloride	54868-4258	CARNAUBA WAX
Physicians Total Care Inc	ALLEGRA D-12 HOUR	fexofenadine hydrochloride and pseudoephedrine hydrochloride	54868-4258	CELLULOSE, MICROCRYSTALLINE
Physicians Total Care Inc	ALLEGRA D-12 HOUR	fexofenadine hydrochloride and pseudoephedrine hydrochloride	54868-4258	CROSCARMELLOSE SODIUM

Allegra-D 12 Hour Excipient Strategy and Commercial Opportunities

Last updated: September 9, 2026

Allegra-D 12 Hour combines fexofenadine hydrochloride 60 mg, a non-sedating antihistamine, with pseudoephedrine hydrochloride 120 mg in an extended-release oral tablet. Its commercial value depends less on active-ingredient exclusivity than on controlled pseudoephedrine distribution, robust modified-release performance, consumer tolerability, and regulatory compliance. The strongest opportunities are generic or private-label substitution, improved tablet robustness, lower-cost excipient systems, and differentiated products that address swallowing, gastrointestinal tolerance, and pharmacy-channel restrictions.

What is the formulation of Allegra-D 12 Hour?

Allegra-D 12 Hour is an extended-release combination tablet containing:

Attribute	Product detail
Brand	Allegra-D 12 Hour
Active ingredients	Fexofenadine hydrochloride 60 mg; pseudoephedrine hydrochloride 120 mg
Dosage form	Extended-release tablet
Route	Oral
Primary indications	Temporary relief of nasal congestion, sinus pressure, sneezing, runny nose, itchy or watery eyes
Typical adult and pediatric dose	One tablet every 12 hours
Maximum labeled use	Two tablets in 24 hours
Key regulatory constraint	Pseudoephedrine sales controls under the Combat Methamphetamine Epidemic Act
Drug class	Antihistamine and nasal decongestant combination

The formulation must release fexofenadine rapidly enough to provide antihistamine activity while controlling pseudoephedrine release over approximately 12 hours. The product therefore presents a formulation challenge that differs from a conventional immediate-release combination tablet.

The FDA label identifies inactive ingredients that include common tablet and film-coating excipients such as microcrystalline cellulose, croscarmellose sodium, hypromellose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, polyethylene glycol, and titanium dioxide. Exact excipient composition can vary by manufacturing site, product revision, and regulatory filing. The current FDA-approved labeling is the controlling source for the commercial product composition (U.S. Food and Drug Administration [FDA], 2024a).

Which excipients are most important in Allegra-D 12 Hour?

The key excipient functions are immediate-release disintegration, pseudoephedrine release control, compression, flow, lubrication, and film coating.

Excipient class	Likely function in the product	Commercial importance
Microcrystalline cellulose	Diluent and compression aid	Supports tablet hardness and manufacturability
Hypromellose	Matrix former or coating polymer	Controls release and improves tablet integrity
Croscarmellose sodium	Superdisintegrant	Promotes rapid breakup of the immediate-release portion
Sodium starch glycolate	Superdisintegrant	Supports rapid drug exposure after tablet hydration
Povidone	Binder	Improves granule and tablet cohesion
Colloidal silicon dioxide	Glidant and moisture-control aid	Improves powder flow and blend uniformity
Magnesium stearate	Lubricant	Reduces ejection force and tooling friction
Polyethylene glycol	Film-coating plasticizer or processing aid	Improves coating flexibility
Titanium dioxide	Opacifier and colorant	Supports appearance and light protection

The formulation strategy must avoid excessive hydrophobic lubrication. High magnesium stearate concentration or extended lubrication can slow wetting and disintegration, which can alter fexofenadine release and the early portion of pseudoephedrine release.

Hypromellose is the most commercially significant excipient because its viscosity grade, particle size, hydration profile, and concentration can affect pseudoephedrine dissolution. A low-viscosity grade may provide insufficient release control. A high-viscosity grade can produce an overly slow release profile, increase tablet size, or create sensitivity to compression force.

What excipient strategy is required for a 12-hour combination tablet?

A viable formulation should separate the performance objectives of the two actives.

Fexofenadine release

Fexofenadine is generally intended to provide relatively rapid antihistamine activity. The formulation should therefore support:

• Fast tablet wetting
• Rapid disintegration or immediate drug liberation
• Adequate dissolution across physiological pH
• Low variability caused by compression force
• Minimal interaction with cationic or highly adsorptive excipients

Microcrystalline cellulose, croscarmellose sodium, and sodium starch glycolate are suitable tools for rapid tablet breakup. The formulation team must balance disintegrant level against tablet mechanical strength. Excessive disintegrant can reduce tensile strength, increase friability, or complicate coating.

Pseudoephedrine release

Pseudoephedrine requires sustained delivery over the dosing interval. A hydrophilic hypromellose matrix is a commercially practical approach because it uses widely available pharmaceutical-grade materials and avoids more complex multiparticulate manufacturing.

The main development variables include:

1. Hypromellose viscosity grade.
2. Polymer concentration.
3. Drug-to-polymer ratio.
4. Tablet porosity.
5. Compression force.
6. Lubrication time.
7. Coating weight gain.
8. Dissolution medium and agitation rate.

The release mechanism can involve polymer hydration, gel-layer formation, diffusion, and matrix erosion. A formulation that releases too quickly may increase early pseudoephedrine exposure and reduce the 12-hour commercial claim. A formulation that releases too slowly may fail comparative dissolution or produce inadequate decongestant activity.

Combination-tablet architecture

A bilayer or functionally segregated tablet may offer better control than a homogeneous blend. One portion can prioritize fexofenadine disintegration, while another controls pseudoephedrine release. The main disadvantages are higher equipment requirements, layer-weight variability, and greater process-validation burden.

A monolithic matrix tablet is simpler and cheaper to manufacture. It may be more attractive for a generic or private-label product if comparative dissolution can be matched without reproducing the branded tablet’s exact architecture.

What formulation patents protect Allegra-D 12 Hour?

The principal commercial barrier is unlikely to be a currently enforceable brand-specific formulation patent. Allegra-D 12 Hour has been marketed for many years, and the product’s active ingredients are established small molecules. Any original patent protection associated with fexofenadine, pseudoephedrine, or the combination would generally have expired or lost practical importance by 2026.

The relevant IP review should focus on:

• Historical patents covering fexofenadine and pseudoephedrine combinations.
• Modified-release matrix patents.
• Tablet architecture and manufacturing patents.
• Orange Book-listed patents associated with the applicable FDA application.
• Patent litigation involving abbreviated new drug applications.
• Trade secrets involving granulation, coating, tooling, and process controls.

A patent search should not assume that the Allegra-D brand name identifies a single patent estate. The commercial product may have changed ownership, manufacturing sites, labeling, or application records over time.

What is the Orange Book status of Allegra-D 12 Hour?

Allegra-D 12 Hour should be evaluated through the FDA Orange Book by product name, active ingredients, dosage form, and application number. Orange Book relevance can be limited for products that are marketed under OTC frameworks or that are not currently listed as prescription products.

The key distinction is between:

• A prescription NDA with Orange Book-listed patents and exclusivities.
• An OTC monograph product.
• An OTC product supported by an approved NDA.
• A private-label or store-brand product that relies on an approved regulatory pathway.

For a prospective competitor, the absence of a current Orange Book patent listing would not eliminate regulatory risk. It would shift the risk assessment toward product-specific bioequivalence, dissolution, labeling, manufacturing, and pseudoephedrine-control requirements.

When does Allegra-D 12 Hour lose exclusivity?

The product’s practical exclusivity has already eroded. Fexofenadine and pseudoephedrine are established active ingredients, and competing products have been available for years. The commercial question is not when brand exclusivity ends. It is whether a competitor can obtain and maintain a compliant product with equivalent release performance and reliable distribution.

Key barriers include:

Barrier	Effect on market entry
Modified-release performance	Requires comparative dissolution and formulation control
Pseudoephedrine regulation	Limits retail access and creates inventory controls
Pharmacy-channel restrictions	Complicates forecasting and distribution
Combination-product labeling	Requires accurate warnings and age restrictions
Manufacturing variability	Can cause dissolution failures
Consumer substitution	Encourages price competition once a generic is available

Are there Paragraph IV challenges for Allegra-D 12 Hour?

Paragraph IV litigation is most relevant when an applicant relies on an abbreviated new drug application against an unexpired Orange Book-listed patent. The commercial significance of a Paragraph IV challenge depends on whether the branded product has live listed patents, the filing date of the ANDA, and the applicant’s certification.

For Allegra-D 12 Hour, the likely risk profile is lower than for a recently approved prescription product because the active ingredients and dosage form are mature. A market entrant would still need to review historical ANDA litigation and any patent listed against the relevant FDA application. No current litigation conclusion should be drawn solely from the brand name.

The more material risks may be:

• Failure to demonstrate equivalent extended-release performance.
• Inability to match dissolution across multiple media.
• Manufacturing changes after approval.
• Labeling differences involving pseudoephedrine controls.
• Supply interruptions caused by controlled-ingredient procurement.

What commercial opportunities exist for excipient suppliers?

Excipient suppliers can target four opportunity areas.

Modified-release polymers

Hypromellose remains the most direct opportunity. Suppliers can differentiate through:

• Consistent viscosity across lots.
• Narrow particle-size distribution.
• Improved compressibility.
• Lower sensitivity to shear and lubrication.
• Documentation supporting global regulatory filings.
• Grades optimized for direct compression.

Ethylcellulose, methacrylate copolymers, and lipid-based barriers could support alternative release technologies, although each introduces additional development and regulatory work.

Direct-compression systems

A co-processed filler-binder system could reduce granulation steps and improve batch-to-batch uniformity. This may be attractive for generic manufacturers seeking lower operating costs and simpler scale-up.

The main technical objective is to produce a tablet with sufficient hardness without slowing immediate-release fexofenadine liberation or creating excessive variability in pseudoephedrine release.

Low-moisture processing

Moisture management matters because polymer hydration, tablet hardness, and active stability can change with water activity. Low-moisture excipient systems, improved packaging, and controlled-humidity manufacturing may reduce dissolution drift during shelf life.

Patient-centered excipients

Potential differentiation includes:

• Smaller tablets through higher-density excipient systems.
• Lower friability for pharmacy handling.
• Reduced chalkiness and improved swallowability.
• Alternative colorants for clean-label positioning.
• Reduced titanium dioxide where permitted and commercially desirable.
• Excipient systems compatible with lactose-free or specific dietary claims.

These improvements may not create strong patent protection, but they can support private-label contracts and retail differentiation.

How does Allegra-D 12 Hour compare with competing products?

Product category	Antihistamine	Decongestant	Release profile	Main commercial distinction
Allegra-D 12 Hour	Fexofenadine	Pseudoephedrine	Extended release	Non-sedating antihistamine plus 12-hour decongestion
Allegra-D 24 Hour	Fexofenadine	Pseudoephedrine	Extended release	Once-daily dosing
Claritin-D 12 Hour	Loratadine	Pseudoephedrine	Extended release	Alternative antihistamine platform
Claritin-D 24 Hour	Loratadine	Pseudoephedrine	Extended release	Once-daily dosing
Zyrtec-D 12 Hour	Cetirizine	Pseudoephedrine	Extended release	Strong allergy recognition, with greater sedation potential in some users
Separate products	Variable	Variable	Immediate or extended release	Flexible titration but more tablets

Allegra-D 12 Hour competes on perceived low sedation, brand recognition, and a two-dose-per-day schedule. Its disadvantages include pseudoephedrine purchase restrictions, potential cardiovascular warnings, and competition from intranasal therapies.

What FDA regulatory requirements affect commercialization?

The product must comply with FDA requirements for the applicable OTC or NDA pathway, including:

• Identity and strength of both active ingredients.
• Extended-release dissolution performance.
• Assay and content uniformity.
• Stability through labeled shelf life.
• Microbiological and elemental impurity controls where applicable.
• Child-resistant packaging requirements.
• Pseudoephedrine sales and transaction controls.
• Accurate Drug Facts labeling.
• Manufacturing under current good manufacturing practice.

Pseudoephedrine is subject to federal sales limits, identification requirements, logbook or electronic-record controls, and restrictions on mail-order and retail distribution under applicable law. State requirements can be more restrictive. These rules create a distribution barrier that does not apply to ordinary fexofenadine-only products (U.S. Congress, 2005).

What generic launch scenarios exist?

Three launch models are commercially plausible.

Low-cost equivalent

This model uses conventional microcrystalline cellulose, hypromellose, superdisintegrants, and standard coating materials. It competes primarily on price and pharmacy availability. The main risk is failure to match the branded dissolution profile.

Private-label retailer product

A retailer or pharmacy chain can use an approved supplier while emphasizing lower price and store-brand loyalty. The commercial advantage is distribution. The limitation is that pseudoephedrine controls still restrict consumer access and inventory movement.

Reformulated differentiated product

A manufacturer could pursue a smaller tablet, improved swallowability, lower-cost coating, or alternative release technology. The product would need a clear regulatory pathway and a commercial claim that justifies development expense.

How strong is the patent estate for Allegra-D 12 Hour?

The estate is likely weak as a current exclusivity barrier but potentially relevant as a historical formulation and process record. The product’s defensibility is more likely to come from:

• Brand awareness.
• Retail placement.
• Supply reliability.
• Pseudoephedrine procurement.
• Manufacturing know-how.
• Consumer familiarity.
• Regulatory execution.

A competitor should assign greater weight to formulation reproducibility and controlled-substance distribution than to expected patent damages exposure. Patent risk remains jurisdiction-specific and requires a current search of FDA records, USPTO records, and court dockets.

What revenue exposure exists for manufacturers?

Revenue exposure is concentrated in the broader oral allergy and congestion market rather than in a single patent-protected product. Brand revenue can decline rapidly after credible generic or store-brand substitution. The impact is moderated by:

• Seasonal demand.
• Retailer inventory cycles.
• Pseudoephedrine restrictions.
• Consumer preference for non-sedating antihistamines.
• Availability of 24-hour alternatives.
• Competition from nasal corticosteroids and antihistamine sprays.

For excipient suppliers, the highest-value accounts are manufacturers with large retail contracts, established pseudoephedrine procurement, and validated extended-release platforms. A formulation that reduces manufacturing complexity can create value even when the final product is sold at a low retail price.

Key Takeaways

• Allegra-D 12 Hour contains fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg in an extended-release tablet.
• The core formulation challenge is rapid fexofenadine availability combined with controlled pseudoephedrine delivery.
• Hypromellose, microcrystalline cellulose, superdisintegrants, binders, glidants, and lubricants are the principal excipient categories.
• The strongest excipient opportunity is a reproducible hypromellose-based matrix with improved compressibility and dissolution control.
• Practical exclusivity is limited because the active ingredients and product category are mature.
• Paragraph IV and Orange Book risk require product-specific review but are unlikely to be the main commercial barrier.
• Pseudoephedrine controls, pharmacy distribution, dissolution matching, and manufacturing consistency are more important launch risks.
• Commercial opportunities include generics, private-label products, smaller tablets, improved coating systems, and lower-cost direct-compression platforms.

FAQs

Can fexofenadine and pseudoephedrine be formulated as an immediate-release tablet?

Yes, but an immediate-release combination would not replicate the 12-hour Allegra-D profile. It would require a different dosing and labeling strategy and could produce higher early pseudoephedrine exposure.

Which excipient is most important for pseudoephedrine release control?

Hypromellose is usually the leading polymer candidate for a hydrophilic extended-release matrix. Its grade and concentration must be optimized against dissolution, tablet size, and mechanical strength.

Does Allegra-D 12 Hour require a controlled-substance manufacturing license?

Pseudoephedrine is regulated as a precursor chemical and is subject to sales, procurement, recordkeeping, and distribution controls. The exact obligations depend on the activity, facility, jurisdiction, and applicable federal and state rules.

Can a manufacturer use a different excipient composition in a generic product?

Yes. A generic product does not generally need to copy the brand’s inactive ingredients. The alternative formulation must meet applicable equivalence, quality, dissolution, stability, labeling, and manufacturing requirements.

Is a 24-hour formulation commercially stronger than Allegra-D 12 Hour?

A 24-hour product offers dosing convenience, but the 12-hour product can compete through lower unit pricing, flexible dosing, and established consumer familiarity. The stronger commercial position depends on retail access, seasonal demand, and comparative formulation performance.

References

1. U.S. Food and Drug Administration. (2024a). Allegra-D 12 hour extended-release tablets: Drug labeling. DailyMed.

2. U.S. Food and Drug Administration. (2024b). Approved drug products with therapeutic equivalence evaluations. FDA Orange Book.

3. U.S. Food and Drug Administration. (2024c). Code of Federal Regulations, Title 21, Parts 210 and 211: Current good manufacturing practice for finished pharmaceuticals. FDA.

4. U.S. Congress. (2005). Combat Methamphetamine Epidemic Act of 2005, Pub. L. No. 109-177, Title VII.

5. U.S. Food and Drug Administration. (2024d). Approved drug product labeling and OTC drug monograph resources. FDA.