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Last Updated: December 22, 2024

Meclizine hydrochloride - Generic Drug Details


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

Meclizine hydrochloride is the generic ingredient in two branded drugs marketed by Casper Pharma Llc, Invagen Pharms, Ivax Sub Teva Pharms, Nexgen Pharma Inc, Pliva, Abc Holding, Amneal Pharms, Anabolic, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma Usa, Bundy, Chartwell Rx, Epic Pharma Llc, Invatech, Jubilant Cadista, Kv Pharm, Rising, Sandoz, Strides Pharma, Superpharm, UDL, Vangard, Watson Labs, and Zydus Lifesciences, and is included in thirty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for meclizine hydrochloride. Thirty-three suppliers are listed for this compound.

Summary for meclizine hydrochloride
US Patents:0
Tradenames:2
Applicants:25
NDAs:38
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 33
Raw Ingredient (Bulk) Api Vendors: 182
Clinical Trials: 10
Patent Applications: 6,801
What excipients (inactive ingredients) are in meclizine hydrochloride?meclizine hydrochloride excipients list
DailyMed Link:meclizine hydrochloride at DailyMed
Recent Clinical Trials for meclizine hydrochloride

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

SponsorPhase
Mansoura UniversityPhase 1/Phase 2
Hospital Federal de BonsucessoPhase 4
Tannaz ArmaghanyPhase 1

See all meclizine hydrochloride clinical trials

Pharmacology for meclizine hydrochloride
Drug ClassAntiemetic
Physiological EffectEmesis Suppression
Medical Subject Heading (MeSH) Categories for meclizine hydrochloride

US Patents and Regulatory Information for meclizine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 084657-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Anabolic MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 085891-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Nexgen Pharma Inc MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET, CHEWABLE;ORAL 086392-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apnar Pharma Lp MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 087128-001 Approved Prior to Jan 1, 1982 AA RX 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

Meclizine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Meclizine Hydrochloride

Introduction to Meclizine Hydrochloride

Meclizine Hydrochloride is a first-generation antihistamine widely used for the symptomatic management of motion sickness, nausea, vomiting, and dizziness. It is also utilized off-label for conditions such as vestibular migraine and is being researched for its potential in treating achondroplasia[4].

Market Size and Growth Projections

The Meclizine Hydrochloride market has been experiencing significant growth and is anticipated to continue this trend. As of 2024, the market was valued at USD 45.6 billion and is projected to reach USD 106.36 billion by 2031, exhibiting a compound annual growth rate (CAGR) of 12.86%[3].

Key Drivers of Market Growth

Increasing Prevalence of Motion Sickness and Vertigo

The rising prevalence of motion sickness and vertigo, particularly among the aging population, is a major driver of the market. Meclizine Hydrochloride's effectiveness in managing these conditions makes it a preferred treatment option[3].

Growing Travel and Recreational Activities

The increase in travel and recreational activities that can trigger motion sickness further boosts the demand for Meclizine Hydrochloride. As more people engage in activities that involve motion, the need for effective treatments like Meclizine Hydrochloride increases[3].

Advancements in Pharmaceutical Research

Advancements in pharmaceutical research are leading to improved formulations and delivery systems, enhancing the drug's efficacy and patient compliance. This continuous innovation supports market expansion and attracts more consumers[3].

Expanding Healthcare Infrastructure

The growing healthcare infrastructure and increased access to medications globally contribute to the market's growth. In regions with improving healthcare systems, the demand for Meclizine Hydrochloride is expected to rise[3].

Broadening Applications

Meclizine Hydrochloride is also being used to treat other conditions, such as nausea associated with chemotherapy, which expands its market reach beyond traditional uses[3].

Market Segmentation

By Type

The Meclizine Hydrochloride market is segmented by type, including 25mg, 12.5mg, and other formulations. Each type caters to different patient needs and preferences, contributing to the overall market growth[1].

By Application

The market is also segmented by application, including various allergic diseases of the skin and mucous membranes, motion sickness, and cartilage hypoplasia. The versatility of Meclizine Hydrochloride in treating multiple conditions enhances its market appeal[1].

By Geographical Region

Geographically, the market is divided into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. North America, particularly the United States and Canada, is a significant player due to its robust economy and strong consumer base. Europe is characterized by a mature market with well-established infrastructure, while the Asia-Pacific region is rapidly growing due to its large population and increasing urbanization[3].

Market Dynamics

Drivers

  • Increasing Urbanization: The rising urban population, especially in urban centers, is propelling the demand for Meclizine Hydrochloride[3].
  • Mergers and Acquisitions: The market is witnessing a wave of mergers and acquisitions, allowing companies to consolidate their market positions, expand product portfolios, and leverage synergies to drive growth and competitiveness[3].
  • Access to New Technologies: Acquisitions provide companies with access to new technologies, intellectual property, and talent, enabling them to innovate faster and stay ahead of market trends[3].

Restraints

  • Adverse Effects: Meclizine Hydrochloride can cause adverse effects such as anticholinergic actions, which pose risks to patients with conditions like asthma, glaucoma, or benign prostatic hyperplasia (BPH)[4].
  • Genetic Polymorphism: The genetic variability in the CYP2D6 enzyme can affect the metabolism of Meclizine Hydrochloride, leading to potential adverse reactions and varying clinical effectiveness[4].

Opportunities

  • Growing Demand for Sustainable Solutions: Growing environmental concerns and stringent regulations are fostering a shift towards sustainable alternatives, which could boost the demand for eco-friendly Meclizine Hydrochloride products and services[3].
  • Emerging Markets: The Middle East and Africa represent emerging markets with promising growth potential due to economic diversification efforts, urbanization, and a young population[3].

Challenges

  • Hepatic and Renal Impairment: There is limited data on how hepatic and renal impairment affect the pharmacokinetics of Meclizine Hydrochloride, requiring caution when administering the drug to patients with these conditions[4].
  • Pregnancy Considerations: Preclinical studies have shown that high doses of Meclizine Hydrochloride can increase the risk of developing cleft palate, although it is generally considered safe for use during pregnancy at recommended doses[4].

Financial Trajectory

The financial trajectory of the Meclizine Hydrochloride market is marked by significant growth. Here are some key financial highlights:

  • Current Valuation: The market was valued at USD 45.6 billion in 2024[3].
  • Projected Valuation: The market is expected to reach USD 106.36 billion by 2031[3].
  • CAGR: The market is anticipated to grow at a CAGR of 12.86% from 2024 to 2031[3].

Key Players

The Meclizine Hydrochloride market includes several key players such as PKU Healthcare, Teva, Orphan Pacific, Catalyst Biosciences, and LGM Pharma. These companies are involved in various strategies including mergers and acquisitions, research and development, and market expansion to maintain their competitive edge[3].

Regional Analysis

North America

North America, particularly the United States and Canada, is a significant player in the global Meclizine Hydrochloride market. The region benefits from a robust economy, technological advancements, and a strong consumer base with high purchasing power[3].

Europe

Europe is another major region, characterized by a mature market with well-established infrastructure and consumer preferences. Countries such as the United Kingdom, Germany, France, and Italy are key contributors to the European market[3].

Asia-Pacific

The Asia-Pacific region is rapidly growing, driven by countries such as China, Japan, India, and South Korea. The large population, rising disposable income, and increasing urbanization in this region lead to greater demand for Meclizine Hydrochloride products and services[3].

Latin America

Latin America presents opportunities and challenges, with countries like Brazil, Mexico, and Argentina being key players. Economic fluctuations and political instability in some countries can impact market dynamics and consumer behavior[3].

Middle East and Africa

The Middle East and Africa represent emerging markets with promising growth potential. Countries like UAE, Saudi Arabia, South Africa, and Nigeria are driving demand due to economic diversification efforts, urbanization, and a young population[3].

Conclusion

The Meclizine Hydrochloride market is poised for substantial growth driven by increasing demand for motion sickness treatments, advancements in pharmaceutical research, and expanding healthcare infrastructure. Despite challenges such as adverse effects and genetic polymorphism, the market's financial trajectory indicates a promising future.

Key Takeaways

  • Market Growth: The Meclizine Hydrochloride market is expected to grow from USD 45.6 billion in 2024 to USD 106.36 billion by 2031.
  • Key Drivers: Increasing prevalence of motion sickness, growing travel activities, advancements in pharmaceutical research, and expanding healthcare infrastructure.
  • Market Segmentation: Segmented by type (25mg, 12.5mg, other), application (motion sickness, allergic diseases, cartilage hypoplasia), and geographical region.
  • Regional Analysis: North America, Europe, Asia-Pacific, Latin America, and Middle East and Africa are key regions.
  • Challenges: Adverse effects, genetic polymorphism, hepatic and renal impairment considerations.

FAQs

  1. What is the current market size and projected growth of the Meclizine Hydrochloride market?

    • The Meclizine Hydrochloride market was valued at USD 45.6 billion in 2024 and is projected to reach USD 106.36 billion by 2031, growing at a CAGR of 12.86%[3].
  2. What are the primary applications of Meclizine Hydrochloride?

    • Meclizine Hydrochloride is primarily used to treat motion sickness, nausea, vomiting, and dizziness. It is also used off-label for managing acute attacks of vestibular migraine and is being researched for treating achondroplasia[4].
  3. Who are the key players in the Meclizine Hydrochloride market?

    • Key players include PKU Healthcare, Teva, Orphan Pacific, Catalyst Biosciences, and LGM Pharma[3].
  4. What are the major drivers of the Meclizine Hydrochloride market?

    • The major drivers include the increasing prevalence of motion sickness and vertigo, growing travel and recreational activities, advancements in pharmaceutical research, and expanding healthcare infrastructure[3].
  5. What are the potential challenges associated with Meclizine Hydrochloride?

    • Potential challenges include adverse effects such as anticholinergic actions, genetic polymorphism affecting metabolism, and considerations for patients with hepatic and renal impairment[4].

Sources

  1. Market Research Intellect: Meclizine Hydrochloride Market Size, Scope And Forecast Report[1].
  2. DrugBank Online: Meclizine: Uses, Interactions, Mechanism of Action[2].
  3. OpenPR: Meclizine Hydrochloride Market Size, Share and Forecast By Key Players[3].
  4. NCBI Bookshelf: Meclizine - StatPearls[4].

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.