List of Excipients in Branded Drug ALLEGRA HIVES 24HR

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Chattem Inc	ALLEGRA HIVES 24HR	fexofenadine hydrochloride	41167-4126	BROWN IRON OXIDE
Chattem Inc	ALLEGRA HIVES 24HR	fexofenadine hydrochloride	41167-4126	CELLULOSE, MICROCRYSTALLINE
Chattem Inc	ALLEGRA HIVES 24HR	fexofenadine hydrochloride	41167-4126	CROSCARMELLOSE SODIUM
Chattem Inc	ALLEGRA HIVES 24HR	fexofenadine hydrochloride	41167-4126	HYPROMELLOSE

Allegra Hives 24HR Excipient Strategy and Commercial Opportunities

Last updated: September 3, 2026

Allegra Hives 24HR is an over-the-counter fexofenadine hydrochloride product containing 180 mg of active ingredient per tablet. Its commercial position depends on brand recognition, rapid consumer access, regulatory compliance, and retail distribution rather than active-ingredient patent protection. The current tablet uses a conventional immediate-release excipient system built around microcrystalline cellulose, starch-based disintegrants, povidone, hypromellose, polyethylene glycol, talc, titanium dioxide, and magnesium stearate.[1]

The strongest excipient opportunities are differentiated delivery formats, dye-free and allergen-positioned formulations, pediatric extensions, improved swallowability, and packaging designed for episodic hives use. A new formulation would need to provide a clear consumer benefit because generic fexofenadine 180 mg tablets are widely available.

What is Allegra Hives 24HR and how is it formulated?

Allegra Hives 24HR is a once-daily oral tablet for relief of hives and associated itching. The active ingredient is fexofenadine hydrochloride, a second-generation antihistamine.[1]

Current active and inactive ingredients

Component	Role in formulation
Fexofenadine hydrochloride, 180 mg	Antihistamine active ingredient
Microcrystalline cellulose	Diluent, compression aid, tablet structure
Corn starch	Filler and disintegration support
Croscarmellose sodium	Superdisintegrant
Sodium starch glycolate	Superdisintegrant
Povidone	Binder
Colloidal silicon dioxide	Glidant and powder-flow aid
Magnesium stearate	Lubricant
Hypromellose	Film-coating polymer
Polyethylene glycol	Film-coating plasticizer
Talc	Coating aid and anti-tacking agent
Titanium dioxide	Opacifier and whitening agent

The listed ingredients indicate a standard direct-compression or dry-granulation architecture with a film-coated immediate-release tablet. The formulation does not rely on a complex controlled-release system, lipid carrier, gastroretentive platform, or biologic stabilization strategy.[1]

What excipient strategy does Allegra Hives 24HR use?

The current excipient strategy prioritizes manufacturability, mechanical strength, rapid disintegration, and low-cost scale-up.

Microcrystalline cellulose and starch provide bulk and compressibility. Croscarmellose sodium and sodium starch glycolate create a dual-disintegrant system, which supports tablet breakup after ingestion. Povidone improves granule or powder cohesion. Colloidal silicon dioxide improves flow, while magnesium stearate controls tooling friction during compression.

The film coat uses hypromellose and polyethylene glycol. That combination supports tablet appearance, handling, swallowing, and moisture protection. Talc reduces sticking during coating, and titanium dioxide provides opacity.

This approach is commercially efficient but offers limited differentiation. Most generic manufacturers can reproduce a comparable immediate-release fexofenadine tablet using standard compendial excipients.

What the excipient system does not currently optimize

The formulation does not appear designed specifically for:

• Rapid oral dissolution in the mouth
• Chewing without bitterness
• Pediatric dosing flexibility
• Liquid dosing
• Sugar-free or low-carbohydrate positioning
• Dye-free consumer positioning
• Enhanced absorption
• Modified release
• High-moisture environmental stability beyond normal film-coating protection

Fexofenadine is generally associated with oral products that do not require a sophisticated absorption-enhancing system. Excipient changes that increase exposure could create regulatory and safety concerns, particularly for an OTC product where the established reference profile is well understood.

What commercial opportunities exist for Allegra Hives 24HR excipient innovation?

The most credible opportunities are consumer-facing dosage-form extensions rather than incremental changes to the existing tablet core.

1. Orally disintegrating tablet

An orally disintegrating tablet could address consumers who have difficulty swallowing during acute hives episodes. A formulation could use crospovidone, mannitol, low-substituted hydroxypropyl cellulose, and taste-masking agents.

The main technical barriers are fexofenadine’s bitter taste, tablet friability, moisture sensitivity, and the relatively high 180 mg dose. A large-dose orally disintegrating tablet may require a porous but mechanically stable structure, potentially using lyophilization, spray drying, or specialized compression.

Commercial value would depend on whether the product can deliver a meaningful convenience advantage over standard tablets and existing dissolving or chewable antihistamine products.

2. Chewable tablet

A chewable version could target adults and adolescents who prefer not to swallow tablets. Mannitol, sorbitol, xylitol, or isomalt could provide bulk and mouthfeel. Sweeteners and flavor systems would be necessary to control fexofenadine bitterness.

A sugar-free chewable format has stronger commercial logic than a sugar-containing version because it can support dental-health and low-sugar positioning. Polyols create potential gastrointestinal tolerance issues at higher quantities, so the dose weight and serving size would require careful control.

3. Oral solution or suspension

A liquid product could improve access for children and adults with dysphagia. Fexofenadine’s aqueous solubility, pH stability, taste, preservative compatibility, and container interaction would determine feasibility.

Potential excipient categories include:

• Purified water
• Buffering agents
• Solubilizers or wetting agents
• Suspending agents
• Sweeteners
• Flavors
• Preservatives
• Chelating agents
• Viscosity modifiers

An oral suspension may be more practical than a clear solution if solubility or taste limits are significant. A multidose liquid creates additional risks involving dosing errors, microbial control, sedimentation, and in-use stability.

4. Dye-free and excipient-reduced tablet

A dye-free Allegra Hives 24HR product could appeal to consumers who avoid colorants or perceive a lower excipient burden as safer. The current film-coated tablet includes titanium dioxide and talc according to the product labeling.[1]

A reformulation could use a transparent or uncoated tablet, a naturally colored coating, or a minimal white coating based on alternative opacifiers. The commercial claim must remain precise. "Dye-free" is easier to substantiate than broad claims such as "clean," "natural," or "non-toxic."

5. Allergen-positioned formulation

A label and supply-chain strategy could emphasize the absence of selected allergens, gluten, lactose, and animal-derived ingredients. The opportunity is mainly packaging and consumer communication because the current listed excipients are conventional pharmaceutical ingredients.

The manufacturer would need supplier-level controls for cross-contact, especially for starch-based materials. Corn starch is listed in the current product, which may matter to consumers seeking highly restricted excipient profiles.[1]

6. Unit-dose and travel packaging

Hives can occur episodically, making portability commercially relevant. Blister packaging, stick packs, and small travel cartons could improve convenience and support pharmacy, grocery, mass retail, and e-commerce channels.

Packaging is not an excipient innovation, but it can increase the value of an otherwise undifferentiated tablet. Moisture-barrier blister materials could also support stability for chewable or orally disintegrating formats.

What FDA regulatory pathway applies to Allegra Hives 24HR?

Allegra Hives 24HR is an OTC drug product. Fexofenadine products may be marketed under the FDA OTC monograph framework when they meet the applicable conditions for use, labeling, dosage, and active ingredient requirements. FDA’s antihistamine monograph establishes conditions for nonprescription antihistamine products, while the product-specific Drug Facts label governs the marketed presentation.[1][2]

A reformulation may require:

• Compliance with the applicable OTC monograph
• Updated Drug Facts labeling
• Manufacturing-process validation
• Stability data
• Inactive-ingredient safety assessment
• Dissolution and performance testing
• Product-specific FDA submission if the formulation falls outside monograph conditions
• New packaging and human-factors review for liquid or pediatric formats

Changing excipients does not automatically create regulatory exclusivity. A new dosage form or formulation may qualify for a separate approval pathway, but commercial protection depends on whether the innovation satisfies patentability, FDA requirements, and consumer demand.

What is the Orange Book status of Allegra Hives 24HR?

Allegra Hives 24HR is an OTC product, and its core commercial protection is not based on a current Orange Book patent listing. Orange Book-based patent litigation is primarily relevant to approved prescription and certain approved drug products submitted through NDA pathways. OTC monograph products generally compete through compliance with the monograph, trademarks, manufacturing capability, and distribution.

The practical consequence is that a generic or store-brand manufacturer can market fexofenadine 180 mg products without waiting for expiry of a current Allegra Hives 24HR product patent, provided the product satisfies the applicable FDA requirements.

When does fexofenadine lose exclusivity?

Fexofenadine’s core active-ingredient and conventional immediate-release tablet exclusivity expired years ago. The market has long included generic fexofenadine products in multiple strengths and dosage forms.

There is no meaningful current market exclusivity associated with the fexofenadine molecule itself. Any remaining defensible rights would more likely involve:

• Brand trademarks
• Specific formulation claims
• Device or packaging claims
• Manufacturing processes
• Trade dress
• Private-label or distribution arrangements

Are Paragraph IV challenges relevant?

Paragraph IV litigation is not the principal entry mechanism for an OTC monograph fexofenadine tablet. A competitor selling a monograph-compliant OTC product does not need to challenge a current Allegra patent in the same way an ANDA applicant challenges an Orange Book-listed patent.

Paragraph IV risk could arise if a specific approved NDA product or separately patented formulation were involved. That is not the central risk for the conventional Allegra Hives 24HR tablet.

How strong is the Allegra Hives 24HR patent estate?

The patent estate is weak for the conventional product and stronger only for genuinely differentiated follow-on formats.

Estate assessment

Asset category	Estimated commercial strength
Fexofenadine active ingredient	Low; mature generic market
Conventional 180 mg tablet	Low; readily reproducible formulation
Standard film coating	Low
Specific orally disintegrating formulation	Moderate if technically narrow and clinically useful
Taste-masked chewable	Moderate, but design-around risk is high
Pediatric liquid or suspension	Moderate if stability and palatability are difficult to replicate
Packaging and dispensing system	Low to moderate
Brand trademark and trade dress	High for consumer recognition, not for generic exclusion
Manufacturing know-how	Moderate if linked to yield, stability, or taste performance

A patentable formulation would need more than a list of routine excipients. Stronger claims would require a defined composition range, measurable performance characteristic, unexpected stability advantage, improved palatability, reduced variability, or a manufacturing process that competitors cannot easily reproduce.

What manufacturing and intellectual-property barriers affect new fexofenadine products?

The active ingredient is commercially available, so API sourcing is not the primary barrier. The more relevant barriers are:

• Taste masking at a 180 mg dose
• Consistent tablet hardness and rapid disintegration
• Moisture control for orally disintegrating products
• Suspension uniformity for liquids
• Preservative effectiveness
• Stability in high-temperature retail environments
• Packaging compatibility
• Supplier qualification for specialty excipients
• Scale-up from laboratory compression to commercial tooling
• Avoidance of trademark and trade-dress infringement

A formulation that uses common excipients will be easy to design around. A formulation that relies on a specialized co-processed excipient, proprietary taste-masking matrix, or tightly defined dissolution profile may create stronger manufacturing friction.

Which companies are challenging Allegra Hives 24HR?

The competitive threat comes primarily from generic and private-label fexofenadine manufacturers rather than from biosimilar developers. Major pharmacy chains, mass retailers, and online platforms can source fexofenadine 180 mg tablets from contract manufacturers and sell them under store brands.

Relevant competitive groups include:

• Generic drug manufacturers
• Retailer private-label suppliers
• Consumer-health companies with antihistamine portfolios
• E-commerce sellers
• Combination allergy and cold-product brands

Biosimilar risk is zero in the conventional sense because fexofenadine is a chemically synthesized small molecule, not a biologic. Competition is generic substitution and brand switching, not biosimilar interchangeability.

How does Allegra Hives 24HR compare with competing antihistamines?

Product category	Active ingredient	Common differentiation
Allegra Hives 24HR	Fexofenadine 180 mg	Once-daily hives positioning, non-drowsy consumer brand
Cetirizine products	Cetirizine 10 mg	Broad allergy use, strong generic presence
Loratadine products	Loratadine 10 mg	Once-daily allergy positioning
Diphenhydramine products	Diphenhydramine	Older sedating antihistamine, lower-cost positioning
Levocetirizine products	Levocetirizine 5 mg	Once-daily allergy positioning

Fexofenadine’s commercial advantage is its established non-drowsy positioning. Its disadvantage is the limited differentiation available from a conventional tablet and the intensity of generic competition.

The best follow-on opportunity is a format that improves convenience without undermining the non-drowsy positioning or creating clinically meaningful exposure changes.

What licensing deals and commercial partnerships exist?

No public licensing arrangement is identified in the FDA product labeling for Allegra Hives 24HR. The product is distributed in the United States by Chattem, Inc., a Sanofi company, according to the label.[1]

For a new excipient-enabled product, likely deal structures would include:

• Technology licensing for orally disintegrating or taste-masked platforms
• Contract development and manufacturing agreements
• Private-label supply arrangements
• Retail-exclusive packaging or dosage forms
• Regional consumer-health licensing
• Co-development of pediatric or liquid products

The strongest licensing asset would be a platform that applies to multiple antihistamines, not a single conventional fexofenadine tablet.

What revenue exposure and launch scenarios exist?

The precise revenue attributable to Allegra Hives 24HR is not separately disclosed in the cited public materials. The product is part of a broader Allegra consumer-health franchise, so SKU-level revenue exposure cannot be reliably isolated from public labeling and regulatory records.

Launch scenarios

Scenario	Commercial outcome
Conventional reformulated tablet	Low incremental value; rapid generic imitation
Dye-free tablet	Moderate niche value; limited pricing power
Chewable tablet	Moderate opportunity if taste is acceptable
Orally disintegrating tablet	Higher convenience value, with technical execution risk
Pediatric liquid	Potentially attractive, but requires stronger safety and dosing controls
Premium blister or travel pack	Moderate margin opportunity with limited regulatory complexity
Combination product	Larger basket opportunity, but greater regulatory and clinical complexity

A premium dosage form would need a clear price-to-convenience relationship. A simple excipient substitution is unlikely to support durable premium pricing.

Key Takeaways

• Allegra Hives 24HR contains 180 mg of fexofenadine hydrochloride in a conventional immediate-release, film-coated tablet.
• Its excipient system is optimized for manufacturing efficiency, compression, disintegration, and coating performance.
• The conventional tablet has limited patent-based defensibility because fexofenadine is a mature generic active ingredient.
• The strongest commercial opportunities are orally disintegrating, chewable, pediatric liquid, dye-free, and travel-oriented formats.
• Taste masking, moisture control, stability, and dose size are the main formulation challenges.
• Paragraph IV litigation and biosimilar competition are not the principal risks for the current OTC product.
• Trademark, distribution, packaging, and consumer recognition are more important than active-ingredient exclusivity.
• A new formulation patent would need measurable technical advantages beyond routine excipient substitution.

FAQs about Allegra Hives 24HR excipients and commercialization

Can Allegra Hives 24HR be reformulated without changing the active ingredient?

Yes. A company can retain fexofenadine hydrochloride at 180 mg while changing the excipient system, dosage form, coating, flavor, packaging, or release characteristics, subject to FDA requirements.

Is Allegra Hives 24HR gluten-free?

The listed ingredients do not identify wheat or gluten, but a gluten-free commercial claim requires manufacturing and supplier controls beyond the ingredient list.[1]

Could a fexofenadine gummy compete with Allegra Hives 24HR?

A gummy could improve consumer appeal, but the 180 mg dose creates a large mass and taste-masking challenge. A gummy would also require careful control of content uniformity, stability, moisture migration, and child-directed labeling.

Can titanium dioxide be removed from the Allegra formulation?

Yes, titanium dioxide can potentially be removed or replaced in a reformulation. The replacement coating must preserve appearance, stability, manufacturability, and regulatory acceptability.

What is the most defensible new patent opportunity for fexofenadine?

A narrow formulation or manufacturing patent covering a demonstrated technical effect, such as improved taste masking, rapid disintegration at a high active load, enhanced suspension stability, or extended shelf life, is more defensible than a broad claim listing ordinary excipients.

References

1. Chattem, Inc. (n.d.). Allegra Hives 24HR: Fexofenadine hydrochloride tablet, film coated, Drug Facts label. U.S. National Library of Medicine, DailyMed.

2. U.S. Food and Drug Administration. (n.d.). 21 C.F.R. Part 341: Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use. Electronic Code of Federal Regulations.

3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Center for Drug Evaluation and Research.

4. Sanofi. (2024). Universal registration document and annual financial report. Sanofi.