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Last Updated: December 22, 2024

HYDROXYZINE Drug Patent Profile


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Which patents cover Hydroxyzine, and what generic alternatives are available?

Hydroxyzine is a drug marketed by Baxter Hlthcare, Altana, Am Regent, Dr Reddys, Fresenius Kabi Usa, Hospira, Pharmafair, Smith And Nephew, Solopak, Watson Labs, Wyeth Ayerst, 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, Usl Pharma, Barr, Beximco Pharms Usa, Duramed Pharms Barr, Impax Labs Inc, Ivax Sub Teva Pharms, Par Pharm, and Vangard. and is included in one hundred and thirty-four NDAs.

The generic ingredient in HYDROXYZINE is hydroxyzine pamoate. There are nineteen drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the hydroxyzine pamoate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hydroxyzine

A generic version of HYDROXYZINE was approved as hydroxyzine pamoate by SANDOZ on December 31st, 1969.

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Drug patent expirations by year for HYDROXYZINE
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Recent Clinical Trials for HYDROXYZINE

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SponsorPhase
Sultan Qaboos UniversityPhase 4
The S.N. Fyodorov Eye Microsurgery State InstitutionEarly Phase 1
Minia UniversityPhase 1

See all HYDROXYZINE clinical trials

US Patents and Regulatory Information for HYDROXYZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Pharms HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 087216-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Quantum Pharmics HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 088540-001 Oct 22, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Able HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride TABLET;ORAL 040563-001 Jul 22, 2004 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Anima HYDROXYZINE HYDROCHLORIDE hydroxyzine hydrochloride SYRUP;ORAL 086880-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

HYDROXYZINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Hydroxyzine

Market Overview

Hydroxyzine, an antihistamine with sedative and anxiolytic properties, is experiencing significant growth in the global pharmaceutical market. The drug is widely used for treating various health conditions, including anxiety disorders, atopic contact dermatitis, urticaria, and histamine-mediated pruritus.

Market Drivers

Increasing Prevalence of Allergic Reactions and Anxiety Disorders

The rising incidence of allergic reactions and anxiety disorders, particularly among the elderly population, is a major driver of the hydroxyzine market. Allergic diseases such as atopic dermatitis and urticaria are becoming increasingly common due to factors like pollution and environmental changes, leading to a high demand for effective treatments[3][4].

Growing Geriatric Population

The global geriatric population is increasing, and this demographic is more susceptible to conditions like insomnia, itching, and mental disorders. This trend is expected to boost the demand for hydroxyzine in regions like China and the United States[4].

Technological Advancements and R&D Investments

Technological advancements and increasing investments in research and development are enhancing the efficacy and safety of hydroxyzine. New formulations, dosage forms, and delivery methods, such as extended-release formulations, are being developed to improve patient outcomes[3][4].

Impact of COVID-19

The COVID-19 pandemic initially disrupted global supply chains but later enhanced awareness of hydroxyzine's clinical safety, effectiveness, and tolerability. This increased awareness has contributed to the growing demand for hydroxyzine post-pandemic[1].

Market Segmentation

By Dosage Form

The market is segmented by dosage form, with tablets being the most prominent segment due to their convenience, long shelf life, and ease of use. Tablets accounted for a significant value share of 38% in 2023[4].

  • Tablets: Dominant segment due to convenience and long shelf life.
  • Capsules: Another popular form, especially for patients who have difficulty swallowing tablets.
  • Injections: Used in severe cases or when oral administration is not feasible.
  • Syrups: Commonly prescribed for infants and young children with skin conditions like eczema and atopic dermatitis[1][3].

By Indication Type

The market is also segmented by indication type, with atopic contact dermatitis being the leading segment.

  • Histamine-Mediated Pruritus: Used to treat itching caused by histamine release.
  • Urticaria: Treats hives, which affect around 20% of people at some point in their lives[4].
  • Atopic Contact Dermatitis: Dominated the indication type segment in 2023, driven by the high prevalence of atopic dermatitis affecting up to 10% of adults and 20% of children[1].

Geographical Analysis

North America

North America is the largest market for hydroxyzine, driven by high awareness of treatment options, advanced healthcare infrastructure, and early adoption of novel medications. The United States is expected to experience a CAGR of 5.9% during the forecast period, totaling USD 258.2 million by 2034[4].

Asia Pacific

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

Europe and Other Regions

Europe and other regions, such as the Middle East and Africa, and South America, also contribute significantly to the global hydroxyzine market. These regions are expected to grow steadily, driven by increasing awareness and demand for antihistamine treatments[3].

Financial Trajectory

Market Size and Growth Rate

The global hydroxyzine market is expected to grow at a compound annual growth rate (CAGR) of over 6.0% from 2024 to 2030, reaching USD 1430 million by 2034. In 2024, the market size is forecast to be around USD 829.9 million[1][4].

Revenue Projections

The market revenue is projected to increase significantly due to the growing demand for hydroxyzine in treating various health conditions. For instance, the demand for prescribed hydroxyzine to treat atopic contact dermatitis has increased market revenue, with atopic dermatitis affecting a significant portion of the global population[1].

Competitive Landscape

The hydroxyzine market is highly competitive, with key players such as Pfizer Inc., GlaxoSmithKline plc, Teva Pharmaceutical Industries, and Novartis International AG. These companies are actively involved in new product launches, partnerships, mergers, and acquisitions to enhance their market presence. They are also investing heavily in research and development to improve hydroxyzine formulations and explore new indications[1][3][4].

Challenges and Restraints

Side Effects

Despite the growing demand, the market faces challenges such as the potential side effects associated with hydroxyzine. For example, excess hydroxyzine prescription among children has been linked to an increased risk of developing tics, anxiety, or conduct disorders[1].

Regulatory Compliance

Companies must navigate the regulatory landscape to maintain compliance with safety and efficacy standards, which can be a significant challenge[3].

Key Takeaways

  • The global hydroxyzine market is expected to grow at a CAGR of over 6.0% from 2024 to 2030.
  • The market is driven by the increasing prevalence of allergic reactions and anxiety disorders.
  • Atopic contact dermatitis is the leading indication type segment.
  • North America and the Asia Pacific region are expected to experience robust growth.
  • Key players are investing in R&D and forming strategic partnerships to enhance their market presence.
  • The market faces challenges such as potential side effects and regulatory compliance.

FAQs

1. What is the expected CAGR of the global hydroxyzine market from 2024 to 2030? The global hydroxyzine market is expected to grow at a CAGR of over 6.0% from 2024 to 2030[1].

2. Which segment dominates the hydroxyzine market by indication type? Atopic contact dermatitis dominates the indication type segment, driven by the high prevalence of atopic dermatitis[1].

3. What is the projected global hydroxyzine market value by 2034? The global hydroxyzine market is projected to reach USD 1430 million by 2034[4].

4. Which region is expected to experience the highest CAGR in the hydroxyzine market? The Asia Pacific region, particularly countries like Japan and South Korea, is expected to witness robust growth, with South Korea expected to experience a CAGR of 8% during the forecast period[4].

5. Who are the key players in the hydroxyzine market? Key players include Pfizer Inc., GlaxoSmithKline plc, Teva Pharmaceutical Industries, and Novartis International AG[1][3][4].

Cited Sources

  1. Grand View Research: Hydroxyzine Market Size, Share And Growth Report, 2030
  2. PharmiWeb: Global Hydroxyzine Market Expected to Surge, Reaching USD 1430 Million by 2034
  3. Mordor Intelligence: Hydroxyzine Imine Market Size (2024 - Mordor Intelligence
  4. Future Market Insights: Hydroxyzine Market Size, Share, Trends & Forecast by 2034 | FMI
  5. Market Research Intellect: Hydroxyzine Imine - Market Research Intellect

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