HYDROXYZINE PAMOATE - Generic Drug Details

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

Hydroxyzine pamoate is the generic ingredient in three branded drugs marketed by Teva, Barr, Beximco Pharms Usa, Duramed Pharms Barr, Heritage Pharma, Impax Labs Inc, Ivax Sub Teva Pharms, Par Pharm, Sandoz, Superpharm, Vangard, Watson Labs, and Pfizer, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for hydroxyzine pamoate. Thirty-one suppliers are listed for this compound.

Summary for HYDROXYZINE PAMOATE

US Patents:	0
Tradenames:	3
Applicants:	13
NDAs:	37
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	1
Patent Applications:	1,503
Drug Prices:	Drug price trends for HYDROXYZINE PAMOATE
Drug Sales Revenues:	Drug sales revenues for HYDROXYZINE PAMOATE
What excipients (inactive ingredients) are in HYDROXYZINE PAMOATE?	HYDROXYZINE PAMOATE excipients list
DailyMed Link:	HYDROXYZINE PAMOATE at DailyMed

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See drug sales revenues for HYDROXYZINE PAMOATE

Recent Clinical Trials for HYDROXYZINE PAMOATE

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

Sponsor	Phase
Shalvata Mental Health Center	N/A

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Pharmacology for HYDROXYZINE PAMOATE

Drug Class	Antihistamine
Mechanism of Action	Histamine Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for HYDROXYZINE PAMOATE

N05BB	Diphenylmethane derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for HYDROXYZINE PAMOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm	HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	087656-001	Jun 11, 1982		DISCN	No	No
Ivax Sub Teva Pharms	HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	087760-001	Mar 5, 1982		DISCN	No	No
Barr	HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	088488-001	Jun 15, 1984		RX	No	No
Sandoz	HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	081128-001	Jun 28, 1991		DISCN	No	No
Ivax Sub Teva Pharms	HYDROXYZINE PAMOATE	hydroxyzine pamoate	CAPSULE;ORAL	087761-001	Mar 5, 1982		DISCN	No	No

HYDROXYZINE PAMOATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydroxyzine Pamoate

Market Overview

The global hydroxyzine market, which includes hydroxyzine pamoate, is poised for significant growth driven by several key factors. Here are the critical market dynamics and financial projections for hydroxyzine pamoate.

Growth Projections

The hydroxyzine market is expected to grow at a compound annual growth rate (CAGR) of over 6.0% from 2024 to 2030, with some forecasts indicating a CAGR of 5.6% until 2034[1][4].

Market Size and Revenue

The global hydroxyzine industry size is forecast to reach USD 829.9 million in 2024 and is projected to rise to USD 1430 million by 2034. This substantial growth is driven by increasing demand for antihistamines and anxiolytic medications[4].

Key Drivers of Growth

Increasing Prevalence of Allergic Conditions

The rising incidence of allergic conditions such as atopic dermatitis, urticaria, and histamine-mediated pruritus is a major driver. For instance, atopic dermatitis affects up to 10% of adults and 20% of children, making it a significant health concern globally[1][3].

Anxiety Disorders

The growing prevalence of anxiety disorders also contributes to the demand for hydroxyzine. In the United States, around 40 million people experience an anxiety disorder each year, prompting a higher demand for medications like hydroxyzine[4].

Geriatric Population and Technological Advancements

The increasing geriatric population and advancements in healthcare technology are additional factors driving market growth. The geriatric population is more susceptible to conditions like insomnia, itching, and mental disorders, which hydroxyzine can treat[1][4].

Regional Market Analysis

North America

North America is expected to witness strong growth, driven by high awareness of treatments, robust healthcare infrastructure, and early adoption of novel medications. The United States, in particular, is anticipated to experience a CAGR of 5.9% during the assessment period, reaching USD 258.2 million by 2034[3][4].

Asia Pacific

The Asia Pacific region, especially countries like Japan and South Korea, is forecast to see robust growth. China's market is poised to advance at a CAGR of 6.3%, driven by an increasing geriatric population and surging demand for antihistamines[4].

Product Formulations and Preferences

Tablets and Extended-Release Formulations

Demand remains high for tablets due to their convenience, long shelf life, and ease of use. Extended-release formulations like hydroxyzine pamoate are also gaining popularity, allowing for less frequent dosing and maintaining therapeutic levels throughout the day[2][4].

Competitive Landscape

The hydroxyzine market is highly competitive, with major players like Teva Pharmaceuticals, Pfizer, Inc., and GSK, plc investing heavily in research and development. These companies are focusing on enhancing formulations, exploring new indications, and developing new delivery methods to maintain market share[4].

Regulatory and Marketing Strategies

Companies are navigating the regulatory landscape to ensure compliance with safety and efficacy standards. New marketing strategies, mergers, partnerships, acquisitions, and distribution agreements are becoming prevalent to expand market reach and customer base[4].

Challenges and Side Effects

While hydroxyzine pamoate has a generally favorable safety profile, it can have side effects such as constipation, confusion, dry mouth, and fatigue. Long-term use may lead to tolerance, dependence, cognitive impairment, weight gain, and rare cardiac effects[2][5].

Awareness and Research Investments

Campaigns to raise awareness about atopic dermatitis and other conditions treated by hydroxyzine are contributing to market growth. Significant investments in research, such as the USD 48 million allocated for atopic dermatitis research in 2022, are expected to drive innovation and demand for hydroxyzine imine drugs[3].

Key Takeaways

• The global hydroxyzine market is expected to grow significantly, driven by the increasing prevalence of allergic conditions and anxiety disorders.
• North America and the Asia Pacific region are key markets, with the United States and China showing strong growth potential.
• Extended-release formulations like hydroxyzine pamoate are gaining popularity due to their convenience and therapeutic benefits.
• Major pharmaceutical companies are investing in R&D and new marketing strategies to maintain market share.
• Awareness campaigns and research investments are crucial for driving market growth.

FAQs

1. What are the primary uses of hydroxyzine pamoate?

Hydroxyzine pamoate is used to treat conditions such as hives, itching, dermatitis, and allergic skin reactions. It is also FDA-approved for short-term use to treat anxiety[5].

2. What is the expected market size of the hydroxyzine industry by 2034?

The global hydroxyzine industry size is projected to reach USD 1430 million by 2034[4].

3. Which regions are expected to see the most significant growth in the hydroxyzine market?

North America, particularly the United States, and the Asia Pacific region, especially Japan and South Korea, are expected to see robust growth[3][4].

4. What are the common side effects of hydroxyzine pamoate?

Common side effects include sleepiness, dizziness, skin reactions, dry mouth, fatigue, headache, constipation, and confusion[5].

5. How does the extended-release formulation of hydroxyzine pamoate differ from the immediate-release formulation?

The extended-release formulation of hydroxyzine pamoate has a longer half-life, allowing for less frequent dosing and maintaining therapeutic levels throughout the day, compared to the immediate-release formulation which requires multiple doses[2].

Cited Sources:

1. Grand View Research - Hydroxyzine Market Size, Share And Growth Report, 2030
2. California Prime Recovery - Hydroxyzine vs Xanax – Navigating the Differences, Uses, and ...
3. Mordor Intelligence - Hydroxyzine Imine Market Size & Share Analysis - Growth Trends
4. Future Market Insights - Hydroxyzine Market Size, Share, Trends & Forecast by 2034 | FMI
5. Talkspace - Hydroxyzine Pamoate: Uses, Side Effects, Dosage - Talkspace