HYDROXYZINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for hydroxyzine hydrochloride and what is the scope of patent protection?

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, Anima, Apozeal Pharms, Chartwell Rx, Hikma, Kv Pharm, Lannett Co Inc, Pai Holdings Pharm, Able, Actavis Elizabeth, Amneal Pharm, Aurobindo Pharma Ltd, Epic Pharma Llc, Graviti Pharms, Halsey, Heritage Pharma, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Pharms, Kvk Tech, Mutual Pharm, Northstar Hlthcare, Nuvo Pharms Inc, Pliva, Prinston Inc, Purepac Pharm, Quantum Pharmics, Rising, Sandoz, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, and Usl Pharma, and is included in one hundred and four 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:	104
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	204
Clinical Trials:	33
Patent Applications:	6,837
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
Sultan Qaboos University	Phase 4
The S.N. Fyodorov Eye Microsurgery State Institution	Early Phase 1
Minia University	Phase 1

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
Sun Pharm Industries	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	089381-001	May 19, 1986		DISCN	No	No
Pharmafair	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	INJECTABLE;INJECTION	088862-001	Feb 14, 1986		DISCN	No	No
Watson Labs	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	086829-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pliva	HYDROXYZINE HYDROCHLORIDE	hydroxyzine hydrochloride	TABLET;ORAL	088619-001	Jan 10, 1986	AB	RX	Yes	Yes

HYDROXYZINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydroxyzine Hydrochloride

Introduction

Hydroxyzine hydrochloride, a versatile antihistamine with sedative and anxiolytic properties, is gaining significant traction in the global pharmaceutical market. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of the hydroxyzine hydrochloride market.

Global Market Size and Forecast

The global hydroxyzine market is projected to experience substantial growth over the coming years. As of 2024, the market size is estimated to be around USD 829.9 million and is expected to rise at a Compound Annual Growth Rate (CAGR) of 5.6% until 2034, reaching a total value of USD 1430 million[1][3].

Key Growth Drivers

Increasing Prevalence of Allergic Conditions

The rising incidence of allergic conditions such as urticaria and atopic dermatitis is a significant driver for the hydroxyzine market. According to the American College of Allergy, Asthma, and Immunology, urticaria affects around 20% of people at some point in their lives, creating a high demand for antihistamines like hydroxyzine[1].

Growing Prevalence of Anxiety Disorders

Anxiety disorders are another major factor contributing to the market growth. In the United States, for instance, around 40 million people experience an anxiety disorder each year, prompting a higher demand for medications like hydroxyzine[1].

Technological Innovations

Advancements in pharmaceutical drug delivery have led to the development of novel formulations such as extended-release tablets, oral solutions, and intramuscular injections. These innovations offer improved bioavailability, better patient compliance, and reduced side effects, further boosting the market[3].

Rising Geriatric Population

The increasing geriatric population, particularly in countries like China, is susceptible to conditions such as insomnia, itching, and mental disorders, which are effectively managed by hydroxyzine. This demographic shift is expected to drive demand for antihistamines in the coming years[1][4].

Market Segmentation

Dosage Form

The hydroxyzine market is segmented based on dosage form, with tablets being the most prominent segment. Tablets accounted for a significant value share of 38% in 2023 due to their convenience, long shelf life, and ease of use. The tablets segment is forecast to reach USD 557.1 million by 2032[1][3].

Route of Administration

The market is bifurcated into oral and intramuscular routes of administration, with the oral segment dominating the market. In 2023, the oral segment accounted for USD 628 million[3].

Indication

Hydroxyzine is used to treat various conditions, including histamine-mediated pruritus, atopic contact dermatitis, and urticaria. The histamine-mediated pruritus segment accounted for USD 376.4 million in 2023[3].

Distribution Channel

The market is segmented into hospital pharmacies, online pharmacies, and retail pharmacies. Hospital pharmacies accounted for USD 391.2 million in 2023, indicating a strong presence in this distribution channel[3].

Regional Analysis

United States

The U.S. market for hydroxyzine is significant, with a revenue of USD 290 million in 2023. It is expected to grow at a CAGR of 5.9% during the forecast period, reaching USD 258.2 million by 2034. The high incidence of anxiety disorders in the U.S. is a key factor driving this growth[1].

China

China's hydroxyzine market is poised to advance at a CAGR of 6.3% during the forecast period, with sales totaling USD 224.9 million by 2034. The growing geriatric population and favorable government policies are key drivers in this region[1].

Japan and South Korea

Japan and South Korea are also expected to witness robust growth, with CAGRs of 7.3% and 8%, respectively. These countries are experiencing an increase in allergic conditions and are benefiting from favorable government support[1].

Competitive Landscape

The hydroxyzine market is highly competitive, with leading players such as Teva Pharmaceuticals, Pfizer, Inc., and GSK, plc. These companies are heavily investing in research and development to enhance hydroxyzine formulations, explore new indications, and develop new delivery methods. Strategies like mergers, partnerships, acquisitions, and distribution agreements are prevalent in the sector to expand market footprint and meet growing demand[1].

Pricing and Accessibility

The cost of hydroxyzine hydrochloride can vary significantly depending on the region and availability of insurance. Without insurance, a 30-tablet supply of 25 mg hydroxyzine HCl can cost around $39, or just over $1 per tablet. However, prices can be significantly reduced using prescription discount cards or other financial assistance programs[2].

Regulatory and Compliance Aspects

Companies in the hydroxyzine market must navigate the regulatory landscape to maintain compliance with safety and efficacy standards. This includes receiving approvals for new products and ensuring adherence to local and international regulations[1].

Technological Advancements

Technological innovations in drug delivery are crucial for the growth of the hydroxyzine market. Extended-release formulations, for example, provide sustained relief from allergic symptoms, enhancing patient convenience and treatment outcomes[3].

Challenges and Pitfalls

Despite the growth prospects, the hydroxyzine market faces challenges such as competition from alternative treatments and the need for continuous innovation to stay competitive. Additionally, variations in insurance coverage, particularly with Medicaid, can affect market dynamics[2][3].

Key Takeaways

• The global hydroxyzine market is projected to reach USD 1430 million by 2034, growing at a CAGR of 5.6%.
• High incidence of allergic conditions and anxiety disorders are key growth drivers.
• Technological innovations in drug delivery are enhancing market growth.
• Regional markets, especially in the U.S., China, Japan, and South Korea, are expected to see significant growth.
• The competitive landscape is characterized by heavy investment in R&D and strategic partnerships.

FAQs

What is the current market size of the hydroxyzine industry?

The global hydroxyzine industry size is forecast to reach USD 829.9 million in 2024[1].

What is the projected CAGR for the hydroxyzine market from 2024 to 2034?

The hydroxyzine market is expected to grow at a CAGR of 5.6% from 2024 to 2034[1].

Which regions are expected to witness robust growth in the hydroxyzine market?

Japan and South Korea are expected to witness robust growth, with CAGRs of 7.3% and 8%, respectively. The U.S. and China are also significant markets with notable growth rates[1].

What are the primary indications for hydroxyzine?

Hydroxyzine is primarily used to treat histamine-mediated pruritus, atopic contact dermatitis, urticaria, and anxiety disorders[3].

How does the cost of hydroxyzine vary with and without insurance?

Without insurance, a 30-tablet supply of 25 mg hydroxyzine HCl can cost around $39. However, prices can be significantly reduced using prescription discount cards or other financial assistance programs[2].

Sources

1. Future Market Insights - Hydroxyzine Market Size, Share, Trends & Forecast by 2034
2. SingleCare - How much is hydroxyzine HCl without insurance?
3. Global Market Insights - Hydroxyzine Market Size, Share & Analysis Report, 2024 – 2032
4. Grand View Research - Hydroxyzine Market Size, Share And Growth Report, 2030