List of Excipients in Branded Drug HYDROXYZINE HYDROCHLORIDE

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Generic Drugs Containing HYDROXYZINE HYDROCHLORIDE

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals USA Inc	hydroxyzine hydrochloride	0093-5060	ANHYDROUS LACTOSE
Teva Pharmaceuticals USA Inc	hydroxyzine hydrochloride	0093-5060	CARNAUBA WAX
Teva Pharmaceuticals USA Inc	hydroxyzine hydrochloride	0093-5060	CELLULOSE, MICROCRYSTALLINE
Teva Pharmaceuticals USA Inc	hydroxyzine hydrochloride	0093-5060	CROSPOVIDONE

What are the Most Frequently-Used Excipients in HYDROXYZINE HYDROCHLORIDE?

# Of NDCs	Excipient
15	ALCOHOL
18	ANHYDROUS CITRIC ACID
2	ANHYDROUS DIBASIC CALCIUM PHOSPHATE
145	ANHYDROUS LACTOSE

Hydroxyzine Hydrochloride Excipient Strategy, Patent Position, and Commercial Opportunities

Last updated: August 22, 2026

Hydroxyzine hydrochloride is a mature, off-patent antihistamine and anxiolytic with limited composition-of-matter protection. Commercial opportunity is concentrated in differentiated oral liquids, pediatric products, preservative-free presentations, hospital-ready unit doses, and formulation improvements that reduce dosing errors or improve acceptability. The core molecule has low patent risk, but regulatory execution, formulation quality, controlled-substance-adjacent prescribing concerns, and competition from hydroxyzine pamoate, cetirizine, diphenhydramine, and nonpharmacologic alternatives constrain pricing.

What is the FDA status of hydroxyzine hydrochloride?

Hydroxyzine hydrochloride is an FDA-approved active pharmaceutical ingredient used primarily for pruritus associated with allergic conditions, anxiety, and preoperative sedation. It is marketed in oral and parenteral dosage forms. Hydroxyzine pamoate is a separate salt and should not be treated as the same active ingredient for abbreviated approval purposes.

Hydroxyzine hydrochloride products include:

Product type	Typical strengths or concentrations	Main commercial use
Tablets	10 mg, 25 mg, 50 mg	Allergy, pruritus, anxiety
Capsules	Market-dependent	Oral therapy where capsule presentation is preferred
Oral solution or syrup	Commonly 10 mg/5 mL or equivalent	Pediatric and geriatric dosing
Injection	Commonly 25 mg/mL or 50 mg/mL	Acute care and preoperative use

FDA labeling identifies hydroxyzine hydrochloride as an antihistamine with sedative and anxiolytic effects. The product is not a biologic, does not require a biosimilar pathway, and is generally eligible for an ANDA pathway when a suitable reference-listed drug and dosage form are available (FDA, 2024a; DailyMed, 2024a).

When does hydroxyzine hydrochloride lose exclusivity?

Hydroxyzine hydrochloride lost practical market exclusivity decades ago. The active ingredient was introduced in the 1950s, and the original patents and regulatory exclusivity periods have expired.

Exclusivity category	Current position
Composition-of-matter patent	Expired
Original formulation patents	Expired or commercially irrelevant
New chemical entity exclusivity	Expired
Pediatric exclusivity	No current commercially meaningful protection identified
Orphan-drug exclusivity	Not applicable to the conventional products
Biologic exclusivity	Not applicable
Orange Book patent term	No meaningful blocking term for the mature active ingredient

A new applicant would not face a live molecule patent blocking conventional hydroxyzine hydrochloride tablets, capsules, oral solutions, or standard injections. The relevant regulatory question is whether the proposed product can qualify for an ANDA under section 505(j), rather than whether the molecule remains patent protected.

What patents protect hydroxyzine hydrochloride products?

No current patent estate appears to provide broad commercial exclusivity for conventional hydroxyzine hydrochloride products. Historical patents covering hydroxyzine, its salts, or early pharmaceutical preparations are expired.

Formulation patents

A new formulation could generate patent claims if it contains a technically non-obvious composition or manufacturing process. Potential claim categories include:

• Taste-masked oral liquids
• Extended-release tablets
• Orally disintegrating tablets
• Multiparticulate granules
• Low-sedation combination products
• Preservative-free aqueous injections
• Improved stability systems
• Unit-dose packaging that controls moisture or light exposure
• Pediatric dosage forms with accurate low-volume dosing

The commercial value of these claims would depend on whether the formulation provides measurable clinical or manufacturing advantages. A simple substitution of common sweeteners, buffers, colors, or flavorants would generally present weak patent subject matter.

Method-of-use patents

A method-of-use patent could be pursued for a new indication, dosing regimen, patient population, or combination treatment. Conventional uses such as pruritus, anxiety, and preoperative sedation have long histories and limited prospects for broad, enforceable exclusivity.

A method patent would have greater commercial value only if it supported a clinically differentiated use, such as a defined dosing protocol for a narrow patient population or a validated combination approach. Even then, enforcement would be difficult where prescribing is discretionary and generic substitution is widespread.

What is the Orange Book status of hydroxyzine hydrochloride?

The Orange Book should be reviewed by active ingredient, dosage form, strength, and reference-listed drug designation before filing. Mature hydroxyzine hydrochloride products generally do not present a current, commercially significant Orange Book patent barrier.

For a conventional ANDA:

1. The applicant identifies the reference-listed drug.
2. The applicant demonstrates pharmaceutical equivalence.
3. The applicant demonstrates bioequivalence where required.
4. The applicant certifies against any listed patents.
5. The applicant addresses labeling, inactive ingredients, stability, and manufacturing controls.

If no relevant patent is listed, a Paragraph IV challenge may not be necessary. If a later-listed formulation patent covers a particular dosage form, a Paragraph IV certification could become relevant, but that risk would attach to the formulation rather than to hydroxyzine hydrochloride itself.

Are there Paragraph IV challenges for hydroxyzine hydrochloride?

Hydroxyzine hydrochloride is unlikely to generate a major current Paragraph IV litigation market because the core product is old and genericized. Any Paragraph IV dispute would more likely involve:

• A newly approved modified-release product
• A proprietary oral liquid
• A novel delivery system
• A combination product
• A formulation patent listed after approval

A conventional immediate-release tablet or oral solution applicant would usually face lower patent litigation exposure than an applicant pursuing a proprietary delivery platform.

What excipients are used in hydroxyzine hydrochloride tablets?

Immediate-release tablets generally use conventional excipient systems. Typical functions include:

Formulation function	Candidate excipient classes	Development objective
Dilution	Lactose, microcrystalline cellulose, dibasic calcium phosphate, mannitol	Dose uniformity and tablet weight
Binding	Povidone, hydroxypropyl cellulose, pregelatinized starch	Granule strength
Disintegration	Crospovidone, croscarmellose sodium, sodium starch glycolate	Rapid tablet breakup
Lubrication	Magnesium stearate, sodium stearyl fumarate	Ejection and manufacturability
Glidant	Colloidal silicon dioxide	Powder flow
Film coating	Hypromellose, polyethylene glycol, titanium dioxide, iron oxides	Appearance, swallowability, light protection
Sweetening or flavoring	Sucralose, aspartame, saccharin, flavor systems	Acceptability in chewable or dispersible products

The preferred formulation depends on the target market. A low-cost generic tablet should prioritize high-speed compression, low friability, rapid disintegration, and broad supplier availability. An orally disintegrating tablet should prioritize mouthfeel, mechanical strength, low residual grittiness, and rapid wetting.

Hydroxyzine hydrochloride is a salt with adequate aqueous solubility for conventional immediate-release development. Formulation value therefore comes less from increasing dissolution and more from taste, dosing flexibility, stability, and patient adherence.

What excipients are best for hydroxyzine hydrochloride oral liquids?

Oral liquid development is the clearest excipient opportunity. Hydroxyzine hydrochloride can produce a strong bitter taste, and the dose is often adjusted by age, weight, indication, or clinical response. A successful product must balance taste masking with chemical stability and dosing accuracy.

Recommended oral-liquid excipient strategy

A commercial oral solution or suspension should assess:

• A buffered aqueous vehicle
• A high-intensity sweetener system
• A compatible flavor system
• A viscosity modifier
• A preservative system, unless the product is unit-dose or preservative-free
• A chelating agent where metal-catalyzed degradation is relevant
• Light-protective packaging if stability data support the requirement

Potential sweetener systems include sucralose, sodium saccharin, acesulfame potassium, or combinations. Sucrose may improve taste but increases sugar content and may be unsuitable for some patients. Polyols such as sorbitol can improve mouthfeel but may cause gastrointestinal effects at higher exposures.

The product should avoid excipients that create unnecessary regulatory or patient-use constraints. For pediatric positioning, developers should evaluate alcohol-free and sugar-free presentations. Propylene glycol and ethanol may complicate pediatric, geriatric, or institutional purchasing decisions, even when permitted by the label.

Solution versus suspension

A clear oral solution offers dose uniformity and simple administration. A suspension may provide better taste masking or permit a more concentrated formulation, but it introduces requirements for:

• Redispersibility
• Sedimentation control
• Shake-before-use labeling
• Dose uniformity throughout container life
• Viscosity control
• Container-closure compatibility

A suspension is commercially defensible only if it solves a material problem, such as improved taste, higher concentration, or reduced dosing volume.

What pediatric formulation opportunities exist for hydroxyzine hydrochloride?

Pediatric hydroxyzine hydrochloride is a practical formulation opportunity because dosing may require small, variable volumes. Product differentiation can focus on reducing measurement error and improving caregiver use.

Priority concepts include:

1. A 10 mg/5 mL sugar-free, alcohol-free oral solution.
2. A concentrated low-volume solution for older children and adolescents.
3. Unit-dose oral syringes prefilled with common doses.
4. A calibrated dosing device packaged with the product.
5. A palatable suspension with documented dose uniformity after shaking.
6. A low-volume dispersible tablet for children who cannot swallow conventional tablets.

The most defensible commercial claims would concern dosing accuracy, stability, taste masking, or a technically differentiated dosage form. A generic oral solution using standard excipients would have lower development cost but limited pricing power.

FDA guidance requires close attention to inactive-ingredient precedent, maximum daily exposure, pediatric acceptability, and measuring-device performance. New excipients or novel exposure levels may shift the product from a straightforward ANDA strategy toward a more complex regulatory pathway (FDA, 2019).

What excipients are relevant to hydroxyzine hydrochloride injections?

Parenteral hydroxyzine hydrochloride products require a conservative excipient strategy. The formulation must control pH, tonicity, particulate matter, sterility, extractables, leachables, and container compatibility.

Relevant formulation elements may include:

• Water for injection
• Sodium chloride or another tonicity-adjusting agent
• A pH-adjusting system
• A suitable preservative for multidose presentations, if justified
• Low-sorption container and closure materials

A preservative-free, single-dose presentation could target hospitals seeking lower preservative exposure and simplified medication-use protocols. The opportunity is technically more demanding than oral solid dosage development because sterile manufacturing and container-closure validation become central commercial barriers.

Injection products also carry higher supply-chain and shortage risk. A reliable contract manufacturing network and validated sterile fill-finish capacity may create more value than a marginal excipient improvement.

How strong is the patent estate for hydroxyzine hydrochloride?

The patent estate is weak for conventional products and potentially moderate for a genuinely differentiated delivery system.

Product concept	Patent strength	Regulatory complexity	Commercial attractiveness
Immediate-release tablet	Low	Low	Low to moderate
Conventional capsule	Low	Low	Low
Standard oral solution	Low	Moderate	Moderate
Taste-masked pediatric solution	Moderate if technically novel	Moderate	Moderate to high
Orally disintegrating tablet	Moderate	Moderate	Moderate
Extended-release product	Potentially moderate to high	High	Uncertain
Preservative-free injection	Moderate formulation opportunity	High	Moderate in institutional markets
Prefilled oral syringe	Packaging and use-system opportunity	Moderate	Moderate
Novel combination product	Potentially high	High	Indication-dependent

Patent strength should be assessed through claim breadth, enablement, freedom to operate, formulation reproducibility, and design-around options. Hydroxyzine's low dose and established chemistry make many formulation concepts easy to replicate unless the claims depend on measurable performance parameters.

Which companies are challenging hydroxyzine hydrochloride products?

The market is supplied by generic manufacturers, contract manufacturers, and pharmaceutical distributors rather than by a single dominant innovator. Competition can include manufacturers such as Hikma, Amneal, Rising Pharmaceuticals, Major Pharmaceuticals, and other FDA-approved or private-label suppliers, depending on dosage form and current product availability.

The competitive field changes by presentation. Tablets are likely to have the highest supplier count and lowest barriers. Oral liquids may have fewer qualified suppliers because of taste, preservative, stability, and packaging requirements. Sterile injections have the narrowest manufacturing base and the greatest potential for supply interruption.

A product launch should therefore prioritize supply reliability, shortage monitoring, wholesaler access, and institutional contracting rather than relying on patent exclusivity.

What commercial opportunities exist for hydroxyzine hydrochloride?

The strongest opportunities are formulation-led rather than molecule-led.

1. Pediatric and caregiver-focused oral liquid

A sugar-free, alcohol-free, palatable solution with an oral syringe can command a modest premium where existing products have poor taste, limited availability, or inconvenient concentration.

2. Institutional oral unit doses

Unit-dose cups, sachets, or prefilled oral syringes can reduce medication errors and support hospitals, emergency departments, behavioral-health facilities, and long-term-care settings.

3. Orally disintegrating tablets

An ODT could target patients with swallowing difficulty and outpatient settings where water is unavailable. The product must avoid a gritty texture and control the bitter taste.

4. Hospital injection supply

A reliable hydroxyzine hydrochloride injection can benefit from contract purchasing, shortage resilience, and ready-to-administer packaging. The economics depend heavily on sterile capacity and procurement contracts.

5. Private-label and co-branded supply

Because the molecule is generic, distributors and retail chains may seek differentiated packaging, dosing devices, or supply guarantees. Private-label programs can produce volume but usually limit margin.

6. Combination or indication-specific development

Combination products may have greater intellectual-property potential but also create clinical, regulatory, and reimbursement risk. The commercial case requires a defined unmet need rather than simple co-packaging.

What revenue exposure exists for hydroxyzine hydrochloride?

Hydroxyzine hydrochloride is unlikely to provide meaningful originator-level revenue because the molecule is generic and competition is broad. Revenue exposure is concentrated in:

• Retail generic volume
• Medicaid and government reimbursement
• Hospital contracts
• Oral-liquid shortages
• Sterile injectable supply constraints
• Private-label distribution
• Formulation premiums

Pricing power is usually highest where there are few suppliers, especially sterile injections and specialized liquids. Tablet markets are more vulnerable to rapid price erosion after launch.

A manufacturer should model three launch scenarios:

Scenario	Product	Expected economics
Commodity generic	Immediate-release tablet	Low margin, high price competition
Differentiated generic	Taste-masked liquid or ODT	Moderate margin, moderate development cost
Institutional specialty	Preservative-free injection or unit-dose system	Higher barriers, contract-driven revenue

What generic launch risks exist for hydroxyzine hydrochloride?

The main risks are regulatory and operational rather than patent-based.

• Reference-product discontinuation or uncertainty
• Inactive-ingredient differences requiring additional justification
• Oral-liquid microbial or preservative failure
• Inadequate taste masking
• Inconsistent suspension redispersibility
• Failure of dissolution or content uniformity
• Sterile manufacturing deviations
• Limited wholesale access
• Rapid price erosion
• Labeling differences between hydroxyzine hydrochloride and hydroxyzine pamoate
• Confusion between salt-specific products during substitution or procurement

A tablet applicant has the lowest technical risk. An oral liquid applicant faces more formulation variability, while an injectable applicant faces the highest quality-system and manufacturing risk.

How does hydroxyzine hydrochloride compare with hydroxyzine pamoate?

Hydroxyzine hydrochloride and hydroxyzine pamoate contain the same active moiety but are different salts with distinct regulatory records, formulations, and product identifiers.

Attribute	Hydroxyzine hydrochloride	Hydroxyzine pamoate
Salt form	Hydrochloride	Pamoate
Common presentations	Tablets, oral liquids, injection	Capsules, oral liquids
Sterile injection use	Available in historical and current products	Generally not the main injectable form
ANDA substitution	Salt-specific regulatory assessment required	Salt-specific regulatory assessment required
Formulation focus	Aqueous liquids and injection compatibility	Capsule and oral suspension development
Patent position	Mature and largely expired	Mature and largely expired

A company should not assume that a hydroxyzine pamoate product can automatically serve as the reference product for a hydroxyzine hydrochloride ANDA. Salt equivalence, labeling, dosage form, and FDA product-specific requirements must be assessed separately.

What licensing deals and settlement agreements affect hydroxyzine hydrochloride?

No major current licensing deal or settlement agreement is central to the conventional hydroxyzine hydrochloride market. The product is generally available through generic manufacturing and distribution arrangements.

Commercial transactions are more likely to involve:

• Contract manufacturing
• Private-label supply
• Hospital purchasing agreements
• Technology licenses for taste masking or ODT manufacture
• Sterile fill-finish partnerships
• Distribution agreements

A licensing strategy could be justified for a proprietary taste-masking platform, novel packaging system, or sterile manufacturing process. Licensing the hydroxyzine molecule itself would provide little strategic value because the active ingredient is widely available.

What geographic markets offer the best opportunity?

The United States offers the clearest ANDA framework but also intense generic competition. European markets may provide opportunities for pediatric liquids and hospital products, but national pricing and reimbursement systems differ. Emerging markets may reward stable, low-cost oral liquids and tablets, although local registration, tender pricing, and counterfeit-control requirements can dominate the business case.

Geographic differentiation may come from:

• Sugar-free formulations for markets with pediatric-care demand
• Unit-dose products for hospitals
• Local-language dosing devices and labeling
• Preservative-free products in markets with strong institutional demand
• Stable formulations for regions with high temperature and humidity

Manufacturing IP is unlikely to be a major barrier for conventional products. Quality systems, sterile capacity, excipient sourcing, and container-closure performance are more important barriers.

Key Takeaways

• Hydroxyzine hydrochloride is an old, genericized active ingredient with no meaningful current composition-of-matter exclusivity.
• Conventional tablets and capsules offer limited margin and low patent protection.
• Pediatric oral liquids, taste masking, accurate dosing devices, ODTs, and preservative-free injections offer the strongest formulation-led opportunities.
• Hydroxyzine hydrochloride and hydroxyzine pamoate are separate salt forms with distinct regulatory considerations.
• Paragraph IV litigation risk is low for conventional products and higher only for novel formulations or delivery systems.
• The FDA pathway is generally an ANDA for established dosage forms, subject to reference-product and inactive-ingredient requirements.
• The most important commercial barriers are product quality, sterile manufacturing, supply reliability, institutional contracting, and price erosion.
• There is no meaningful biosimilar risk because hydroxyzine hydrochloride is a small-molecule drug.

FAQs

Can hydroxyzine hydrochloride be developed as a 505(b)(2) product?

Yes, but a conventional tablet, capsule, or oral solution generally fits an ANDA strategy if an appropriate reference product exists. A 505(b)(2) application becomes more relevant for a novel dosage form, new route, new strength, or clinically differentiated formulation.

Is hydroxyzine hydrochloride compatible with sugar-free pediatric formulations?

It can be, subject to stability, taste, preservative, and inactive-ingredient review. Polyols and high-intensity sweeteners may support sugar-free positioning, but each system requires palatability and gastrointestinal-tolerability assessment.

Does hydroxyzine hydrochloride require a taste-masking patent?

No. A taste-masking patent is optional. Commercial protection is more credible when the formulation demonstrates a defined taste-masking mechanism, dissolution profile, stability advantage, or manufacturing benefit.

Is an extended-release hydroxyzine hydrochloride product commercially attractive?

The concept has potential but carries higher development and regulatory risk. Hydroxyzine's sedative effects, dose timing, pharmacokinetics, and clinical tolerability would need to support a clear advantage over immediate-release products.

Can hydroxyzine hydrochloride injection support a premium generic strategy?

Yes, particularly where competitors have supply interruptions or limited sterile capacity. The premium depends on validated sterility, container-closure performance, ready-to-administer packaging, and hospital procurement access.

References

1. DailyMed. (2024a). Hydroxyzine hydrochloride tablet and oral solution labeling. U.S. National Library of Medicine.

2. U.S. Food and Drug Administration. (2019). Size of commonly used pediatric oral liquid medications: Guidance for industry. FDA.

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

4. U.S. Food and Drug Administration. (2024b). Inactive ingredient database. FDA.

5. U.S. Food and Drug Administration. (2024c). ANDA submissions: Content and format of an abbreviated new drug application. FDA.

6. U.S. National Library of Medicine. (2024). Hydroxyzine hydrochloride drug labels and product listings. DailyMed.