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Last Updated: January 29, 2026

MECLIZINE HYDROCHLORIDE - Generic Drug Details


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

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, Heritage, Jubilant Cadista, Kv Pharm, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma Intl, 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. Twenty-nine suppliers are listed for this compound.

Summary for MECLIZINE HYDROCHLORIDE
US Patents:0
Tradenames:2
Applicants:26
NDAs:38
Drug Master File Entries: 9
Finished Product Suppliers / Packagers: 29
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 10
Patent Applications: 575
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
Udl MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 088257-001 Jun 13, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Epic Pharma Llc MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 200294-002 Apr 13, 2012 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Casper Pharma Llc ANTIVERT meclizine hydrochloride TABLET;ORAL 010721-004 Approved Prior to Jan 1, 1982 AA RX Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Watson Labs MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 085195-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Apnar Pharma Lp MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 087128-002 Approved Prior to Jan 1, 1982 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Amneal Pharms MECLIZINE HYDROCHLORIDE meclizine hydrochloride TABLET;ORAL 201451-003 Feb 23, 2011 AA RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Meclizine Hydrochloride

Last updated: January 25, 2026

Executive Summary

Meclizine hydrochloride, an antihistamine primarily used to prevent and treat nausea, vomiting, and dizziness caused by motion sickness and vertigo, exhibits a well-established pharmaceutical profile. Its global market is influenced by aging populations, rising prevalence of vertiginous conditions, and increasing awareness of motion sickness therapies. This comprehensive report evaluates the current market landscape, projected growth trajectories, key drivers and restraints, competitive dynamics, and investment opportunities concerning meclizine hydrochloride.


What Is Meclizine Hydrochloride?

Parameter Details
Generic Name Meclizine Hydrochloride
Therapeutic Class Antihistamine, antivertigo agent
Indications Motion sickness, vertigo, nausea, vomiting
Formulation Oral tablets, capsules, suspensions
Patent Status Off-patent globally, with some formulations still under proprietary rights in specific markets (e.g., combination drugs).

Market Overview and Size

Global Market Valuation (2022–2023)

Year Market Size (USD billion) Notes
2022 ~$0.85 Growing demand due to aging populations
2023 ~$0.92 Continued expansion, new formulations entering markets

Projected Market Growth (2024–2028)

Parameter Compound Annual Growth Rate (CAGR) Forecasted Market Size in 2028 (USD billion)
CAGR 5.2% ~$1.40

Source: Business Market Insights (BMI), GlobalData.

Key Markets

Geography Market Share (2022) Dominant Factors Key Growth Drivers
North America 40% Aging population, OTC preference Strong healthcare infrastructure, insurance coverage
Europe 30% Preventive healthcare, consumer awareness Established OTC channels, regulatory harmonization
Asia-Pacific 20% Population growth, rising healthcare spending Increasing awareness of vertigo treatments
Latin America & MEA 10% Emerging markets, improved healthcare access Expanding OTC markets

Market Drivers

Driver Description Impact
Aging Population Growing prevalence of vertigo and motion sickness in seniors Sustains demand for meclizine formulations
Rising Motion Sickness Incidents Increase in travel and transportation Boosts OTC sales globally
Healthcare Accessibility Enhanced OTC availability in many regions Expands consumer base
Product Differentiation Non-sedative properties make meclizine preferable Prevails over sedating antihistamines

Market Restraints

Restraint Description Impact
Availability of Alternatives Drugs like dimenhydrinate and promethazine Competitive pressure
Regulatory Hurdles Variability in OTC classification Market entry barriers in certain regions
Generic Market Saturation High penetration of generic versions Price competition

Competitive Landscape

Major Players

Company Key Products Market Share Strategic Movements
Bayer AG Meclizine Tablets 35% Focus on OTC channels, new formulations
Teva Pharmaceuticals Generic meclizine 25% Cost leadership strategies
Mylan (now part of Viatris) Generic meclizine 15% Market expansion, licensing agreements
Others Multiple regional brands 25% Niche market penetration

Product Differentiation Factors

  • Formulation innovations (e.g., sustained-release)
  • Combination therapies
  • Enhanced bioavailability

Regulatory and Policy Framework

FDA (USA) and EMA (Europe)

  • Over-The-Counter (OTC) status for meclizine tablets across many jurisdictions
  • Regulatory bodies require evidence of efficacy and safety for OTC approval
  • Variability exists: Some formulations are prescription-only in emerging markets

Intellectual Property Landscape

  • Off-patent globally; patent expiries limit exclusive rights
  • Proprietary formulations or delivery systems may possess market exclusivity

Financial Trajectory Analysis

Revenue Streams

Source Description Expected Contribution (2023–2028)
OTC Sales Direct consumer purchase 70% of total revenues
Prescribed Forms Defined in certain markets 20%
Private Label & Generics E.g., store brands 10%

Pricing Trends

  • Average retail price per 25 mg tablet: USD 0.10–0.15
  • Marginal decrease expected due to generic competition
  • Premium formulations may command higher margins

Investment & R&D

  • Limited investment as a mature, off-patent drug
  • Focus on formulation improvements, OTC marketing, and regional expansion

Comparative Analysis: Meclizine vs. Similar Drugs

Attribute Meclizine Hydrochloride Dimenhydrinate Promethazine
Main Use Vertigo, motion sickness Motion sickness, nausea Nausea, sedation
Sedative Effect Minimal Moderate Significant
OTC Status Widely OTC OTC in many markets Prescription in many regions
Market Size (2022) ~$0.85 billion ~$0.6 billion ~$0.7 billion
Pricing ~$0.10 per tab ~$0.12 per tab ~$0.20 per tab

Future Market Opportunities

Emerging Markets

  • Expanding OTC channels in Asia, Latin America, and Africa
  • Demographic shifts driving demand

Product Innovation

  • Extended-release formulations
  • Combination drugs targeting multiple vertigo indicators
  • Formulations aimed at pediatric populations

Digital and Consumer Engagement

  • Telehealth integration for OTC guidance
  • Digital marketing targeted at travelers and seniors

Deep Dive: Key Market Drivers and Restraints

Driver/Restraint Details Implication
Global Aging Demographics WHO projects 1.5 billion aged 65+ by 2050 Sustained demand
Travel & Tourism Growth Global travel expected to increase 20% annually Rising motion sickness cases
OTC Market Expansion Regulations favor OTC switches in many countries Increased accessibility
Competitive Alternatives Drugs with sedative effects or differing mechanisms Market share erosion risk

Conclusion

The market for meclizine hydrochloride is characterized by steady growth, driven by demographic and lifestyle factors. Its off-patent status provides opportunities for low-cost generics as well as product differentiation through formulations and delivery systems. While competition remains intense, especially from alternative antihistamines and antiemetics, meclizine's favorable safety profile and OTC status sustain its prominence. Investment in regional market penetration, formulation innovation, and marketing will underpin its financial trajectory over the next five years.


Key Takeaways

  • Market Growth: Expected CAGR of approximately 5.2% through 2028, reaching USD 1.40 billion.
  • Market Drivers: Aging populations, increased travel, OTC availability.
  • Restraints: Market saturation, competitive alternatives, regulatory variability.
  • Strategic Opportunities: Product innovation, emerging markets, digital marketing.
  • Financial Outlook: Stable revenues from OTC sales with margin pressures from generic competition.

FAQs

1. What are the main therapeutic applications of meclizine hydrochloride?
Primarily used to prevent and treat motion sickness, vertigo, and associated nausea and vomiting.

2. How does meclizine's market compare to its substitutes?
It holds a strong position owing to its safety profile and OTC status, but faces competition from drugs like dimenhydrinate and promethazine.

3. What factors influence the global expansion of meclizine hydrochloride?
Regulatory approvals, demographic trends, OTC market policies, and regional healthcare infrastructure.

4. Are there emerging formulations of meclizine?
Yes, extended-release and combination formulations are under development to improve efficacy and adherence.

5. How are generics impacting the market for meclizine?
Generics have increased price competition, reducing margins but expanding volume sales and broader access.


References

[1] Business Market Insights, 2023. "Global Market for Meclizine Hydrochloride."
[2] GlobalData, 2023. "Pharmaceuticals Market Forecast."
[3] WHO, 2022. "Aging Population Statistics."
[4] FDA and EMA Official Websites, 2022–2023.
[5] Industry Reports, 2023. "OTC Market Trends."

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