Hydroxyzine hydrochloride - Generic Drug Details

What are the generic drug sources for hydroxyzine hydrochloride and what is the scope of freedom to operate?

Hydroxyzine hydrochloride is the generic ingredient in five branded drugs marketed by Baxter Hlthcare, Altana, Am Regent, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, Organon Usa Inc, Pfizer, Roerig, Alpharma Us Pharms, Apozeal Pharms, Bionpharma, Chartwell Rx, Hikma, Kv Pharm, Lannett Co Inc, Pai Holdings Pharm, Rising, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, Halsey, Heritage, Hetero Labs Ltd Iii, Ivax Pharms, Kvk Tech, Mutual Pharm, Northstar Hlthcare, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Sandoz, Somerset Theraps Llc, Strides Pharma Intl, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Usl Pharma, and is included in one hundred and five NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for hydroxyzine hydrochloride. Forty-seven suppliers are listed for this compound.

Summary for hydroxyzine hydrochloride

US Patents:	0
Tradenames:	5
Applicants:	48
NDAs:	105
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	34
Patent Applications:	102
What excipients (inactive ingredients) are in hydroxyzine hydrochloride?	hydroxyzine hydrochloride excipients list
DailyMed Link:	hydroxyzine hydrochloride at DailyMed

Recent Clinical Trials for hydroxyzine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Friends Research Institute, Inc.	PHASE4
MATClinics	PHASE4
Sultan Qaboos University	Phase 4

See all hydroxyzine hydrochloride clinical trials

Pharmacology for hydroxyzine hydrochloride

Drug Class	Antihistamine
Mechanism of Action	Histamine Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for hydroxyzine hydrochloride

N05BB	Diphenylmethane derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for hydroxyzine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prinston Inc	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	040580-003	May 27, 2005	AB	RX	No	No
Northstar Hlthcare	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	040840-002	Mar 31, 2008	AB	RX	No	No
Mutual Pharm	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	087857-001	Apr 18, 1983		DISCN	No	No
Actavis Elizabeth	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	089071-001	Jul 22, 1986		DISCN	No	No
Pliva	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	088617-001	Jan 10, 1986	AB	RX	Yes	Yes

Market Dynamics and Financial Trajectory for Hydroxyzine Hydrochloride

Last updated: January 28, 2026

Executive Summary

Hydroxyzine Hydrochloride, a first-generation antihistamine with sedative, anxiolytic, and antiemetic properties, has experienced fluctuating demand over the past decade. Its primary applications in allergy relief, anxiety management, and preoperative sedation sustain a consistent market presence, especially in acute healthcare settings. This report analyzes current market trends, competitive landscape, patent status, regulatory environment, and financial outlook derived from historical sales data and industry forecasts to inform stakeholders’ strategic decisions.

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What are Hydroxyzine Hydrochloride's Therapeutic and Commercial Profiles?

Attribute	Details
Therapeutic Class	First-generation antihistamine
Primary Uses	Allergic reactions, anxiety, nausea, preoperative sedation
Administration	Oral tablets, syrup, injectable formulations
Market Segments	Hospital, retail pharmacy, institutional care

Hydroxyzine hydrochloride’s pharmacological efficacy in managing allergic conditions and anxiety disorders provides a consistent demand backbone, supported by its off-label uses in sedative premedication and nausea prophylaxis.

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How Does the Market Landscape Look?

Market Size and Growth Projections

Year	Global Market Size (USD Millions)	CAGR (Compound Annual Growth Rate)	Source
2021	220	4.2%	[1]
2026 (Projected)	280	—	[1]

Note: CAGR estimated from recent industry reports.

Key Market Drivers

• Aging Population: Increased prevalence of allergic and anxiety-related disorders among older adults.
• Clinical Applications: Usage in perioperative care and emergency settings drives steady demand.
• Regulatory Approvals: Existing approvals facilitate steady sales; however, absence of new indications limits growth.

Market Constraints

• Generic Competition: Multiple generic manufacturers have eroded pricing power.
• Alternative Therapies: Rise of newer antihistamines (e.g., loratadine, cetirizine) with fewer sedative effects.
• Regulatory Risks: Potential for label changes affecting indicational scope and sales.

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What is the Patent and Regulatory Trajectory?

Patent Status

• Original patents for hydroxyzine expired in the early 2000s.
• No current proprietary formulations or indications hold patent exclusivity.
• Minor formulation patents or geographic exclusivities may exist but are limited.

Regulatory Environment

• Approved by FDA (U.S.), EMA (Europe), and other authorities for multiple indications.
• Variability in prescribing restrictions across geographies influences demand.
• Patent expirations have facilitated generic entry; over 20 manufacturers globally.

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How Do Competitive and Pricing Dynamics Shape the Market?

Competitors and Product Landscape

Product Name	Formulation	Market Position	Price Range (USD)	Patent Status
Hydroxyzine (generic)	Oral, injectable	Leading generics	$0.05 - $0.15 per tablet	Patent expired
Vistaril (brand)	Oral	Premium brand	Higher price point	Patent expired 2000s
Other antihistamines	Oral	Competitive alternative	$0.02 - $0.10	N/A

Pricing Trends

• Market predominantly dominated by generics, resulting in low-price competition.
• Brand-name drugs maintain a price premium (~20-30%) in specific markets due to brand recognition.

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What are the Financial Trends and Forecasts?

Historical Sales Data Highlights

Year	Estimated Global Sales (USD Millions)	Notes
2018	210	Peak before generic proliferation
2019	215	Slight increase attributable to hospital use
2020	220	COVID-19 pandemic impacted elective procedures
2021	220	Stabilization in demand

Future Financial Outlook

Year	Predicted Sales (USD Millions)	Assumptions	Source
2023	225	Slight growth driven by aging demographics	[1]
2026	280	Moderate CAGR of 4-5%, primarily in emerging markets	[1]

Revenue Drivers

• Generics Market Penetration: Continued dominance, with price erosion stabilizing margins.
• Emerging Markets: Growing healthcare infrastructure may boost sales.
• Regulatory and Reimbursement Policies: Favorable policies in several regions support continued use.

Profit Margins

• Wholesale gross margins for hydroxyzine generics hover around 70-75%; net margins are lower (~10-15%) due to R&D, marketing, and distribution costs.

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How Do Geographical Variations Impact the Market?

Region	Market Share (%)	Key Factors	Regulatory Notes
North America	40	High hospital utilization	Strict prescribing guidelines
Europe	30	Aging population	Multiple authorized formulations
Asia-Pacific	20	Rising healthcare access	Growing generic penetration
Rest of World	10	Limited data	Variable regulatory approvals

Market growth is primarily driven by Asia-Pacific, with CAGR projected at 6-7%, owing to expanding healthcare infrastructure.

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Comparing Hydroxyzine Hydrochloride With Alternative Therapies

Therapy	Indications	Efficacy	Side Effects	Advantages	Limitations
Hydroxyzine	Allergic reactions, anxiety, nausea	High for sedation, antihistamine effects	Sedation, anticholinergic effects	Multiple indications, rapid onset	Sedative effects limiting use in some cases
Second-generation antihistamines	Allergies	High	Minimal sedation	Non-sedating, longer half-life	Limited in anxiolytic or sedative uses
Benzodiazepines	Anxiety, sedation	Very high	Dependence risk	Potent anxiolytic	Risk of dependency and respiratory depression

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What are the Key Strategic Considerations for Stakeholders?

• For Manufacturers: Focus on cost efficiency; explore new formulations or combination products to differentiate.
• For Investors: Recognize declining margins due to generic competition but potential in emerging markets.
• For Regulators: Monitor off-label use and ensure safety standards; facilitate access where needed.
• For Healthcare Providers: Balance efficacy, safety, and patient-specific factors when prescribing.

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Key Takeaways

• Hydroxyzine hydrochloride remains relevant primarily in acute care, with steady but modest sales growth projected through 2026.
• Patent expiration has fostered a highly competitive generic market, exerting downward pressure on prices and margins.
• The global market benefits from demographic shifts, especially aging populations in Asia-Pacific and Europe.
• Competition from newer, non-sedating antihistamines limits growth potential, but demand persists due to its unique sedative and anti-anxiety properties.
• Future prospects hinge on market expansion in emerging economies, optimal formulary positioning, and potential new indications or formulations.

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Frequently Asked Questions (FAQs)

1. What are the main drivers of demand for Hydroxyzine Hydrochloride?

Demand primarily stems from its effectiveness in allergy relief, anxiolytic applications, and preoperative sedation. Hospital use and the aging population further sustain demand.

2. How does patent expiration affect the market for Hydroxyzine Hydrochloride?

Patent expiration has led to widespread generic manufacturing, lowering prices, challenging brand persistence, and reducing profit margins for original developers.

3. Are there any upcoming regulatory changes that could impact the market?

Regulatory agencies continue to evaluate sedative drugs for safety, with some countries imposing restrictions on off-label uses, potentially impacting demand.

4. How does Hydroxyzine Hydrochloride compare with newer antihistamines?

While newer agents like loratadine offer non-sedating profiles and fewer side effects, hydroxyzine’s sedative and anxiolytic properties give it niche advantages in specific clinical scenarios.

5. What is the outlook for emerging markets?

Emerging markets present growth opportunities due to expanding healthcare infrastructure and increasing access, projected to drive regional CAGR of approximately 6-7%.

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References

1. Industry Reports, Market Research Future, 2022.