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Last Updated: December 22, 2024

CLEMASTINE FUMARATE - Generic Drug Details


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What are the generic drug sources for clemastine fumarate and what is the scope of patent protection?

Clemastine fumarate is the generic ingredient in three branded drugs marketed by Actavis Mid Atlantic, Apotex Inc, Genus, New Heightsrx, Teva Pharms, Wockhardt Bio Ag, Novartis, Ani Pharms, L Perrigo Co, Omnivium Pharms, Pld Acquisitions Llc, Teva, and Haleon Us Holdings, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for CLEMASTINE FUMARATE
US Patents:0
Tradenames:3
Applicants:13
NDAs:14
Finished Product Suppliers / Packagers: 4
Raw Ingredient (Bulk) Api Vendors: 86
Clinical Trials: 10
Patent Applications: 6,281
What excipients (inactive ingredients) are in CLEMASTINE FUMARATE?CLEMASTINE FUMARATE excipients list
DailyMed Link:CLEMASTINE FUMARATE at DailyMed
Recent Clinical Trials for CLEMASTINE FUMARATE

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

SponsorPhase
United States Department of DefensePhase 1/Phase 2
University of California, San FranciscoPhase 1/Phase 2
Amsterdam UMC, location VUmcPhase 3

See all CLEMASTINE FUMARATE clinical trials

Medical Subject Heading (MeSH) Categories for CLEMASTINE FUMARATE

US Patents and Regulatory Information for CLEMASTINE FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Haleon Us Holdings TAVIST-1 clemastine fumarate TABLET;ORAL 020925-001 Aug 21, 1992 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis TAVIST clemastine fumarate TABLET;ORAL 017661-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
New Heightsrx CLEMASTINE FUMARATE clemastine fumarate SYRUP;ORAL 074884-001 Dec 17, 1997 AA RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva CLEMASTINE FUMARATE clemastine fumarate TABLET;ORAL 073283-001 Jan 31, 1992 RX No Yes ⤷  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

CLEMASTINE FUMARATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Clemastine Fumarate

Introduction

Clemastine Fumarate is an antihistamine with a broad range of therapeutic applications, including the treatment of allergic rhinitis, conjunctivitis, dermatitis, and urticaria. Here, we delve into the market dynamics and financial trajectory of this drug, exploring its current market status, growth prospects, and the factors influencing its market performance.

Market Size and Share

The global Clemastine Fumarate market has shown significant growth in recent years. As of 2023, the market size is substantial, with the Above 99.0% purity segment accounting for a noticeable share of the global market. This segment is projected to experience significant growth in the near future, driven by increasing demand for high-quality pharmaceutical products[1].

Regional Analysis

The market for Clemastine Fumarate is geographically diverse, with key regions including North America, Europe, Asia Pacific, South America, and the Middle East & Africa. Each region has its own market dynamics, influenced by factors such as the availability of raw materials, regulatory environments, and local demand. For instance, Asia Pacific, particularly China, is showing significant progress in the development and consumption of Clemastine Fumarate, indicating a potential for further growth and innovation in this region[1][4].

Application Segments

Clemastine Fumarate is segmented into various application areas, with the antihistaminic segment being the most prominent. This segment is expected to expand at a significant Compound Annual Growth Rate (CAGR) throughout the forecast period, driven by the increasing prevalence of allergic conditions and the drug's effectiveness in alleviating symptoms associated with these conditions[1][4].

Key Applications

  • Allergic Rhinitis: Clemastine Fumarate is widely used to treat symptoms of allergic rhinitis, such as sneezing, itching, and a runny or stuffy nose.
  • Conjunctivitis: It helps relieve symptoms of allergic conjunctivitis, including redness, itching, and watering of the eyes.
  • Dermatitis and Eczema: The drug is effective in managing inflammatory skin conditions characterized by redness, itching, and rash.
  • Pruritus: Clemastine Fumarate provides relief from itching caused by various allergic reactions or skin conditions.
  • Urticaria: It is used to treat urticaria, or hives, which are raised, itchy, and red welts on the skin often caused by an allergic reaction[4].

Competitive Landscape

The competitive landscape of the Clemastine Fumarate market is characterized by several key players, including Sekisui Medical and Shandong Keyuan Pharmaceutical. These companies are focusing on strategic models to strengthen their product portfolios and expand their business globally. The market is also seeing competition from other pharmaceutical giants such as GSK Plc, Sanofi, and Bayer AG, which are actively involved in the development of H1 receptor-targeting drugs[1][4].

Market Drivers

Several factors are driving the growth of the Clemastine Fumarate market:

  • Increasing Prevalence of Allergic Conditions: The rising incidence of allergic diseases is a significant driver, as more people seek effective treatments for conditions like allergic rhinitis and urticaria.
  • Technological Advancements: Advances in pharmaceutical technology are leading to the production of high-quality chemicals, which is increasing demand for Clemastine Fumarate.
  • Regulatory Support: Favorable regulatory environments in various regions are facilitating the approval and distribution of Clemastine Fumarate[1][4].

Market Restraints

Despite the growth drivers, there are several restraints that could impact the market:

  • Competition from Biosimilars: The potential entry of biosimilars could pose a challenge to the market dominance of Clemastine Fumarate.
  • Regulatory Challenges: Stringent regulatory requirements and potential changes in regulatory policies can affect the market dynamics.
  • Side Effects and Safety Concerns: Adverse effects associated with antihistamines, such as CNS depression or stimulation, can influence consumer behavior and regulatory scrutiny[2][4].

Financial Trajectory

The financial trajectory of Clemastine Fumarate is promising, with the market expected to grow significantly from 2025 to 2031. Here are some key financial insights:

  • Revenue Growth: The market is projected to see substantial revenue growth, driven by increasing demand and expanding applications.
  • CAGR: The antihistaminic segment, in particular, is expected to expand at a significant CAGR, contributing to the overall market growth.
  • Regional Contributions: Asia Pacific and North America are expected to be major contributors to the market revenue, driven by high demand and advanced healthcare infrastructure[1].

Technological Trends

The pharmaceutical industry is witnessing significant technological advancements, which are impacting the production and development of Clemastine Fumarate:

  • Small Molecule Drugs: The development of small molecule drugs targeting the H1 receptor is progressing rapidly, indicating intense competition and potential innovation.
  • Biosimilar Competition: The emergence of biosimilars is a technological trend that could shape the future of the Clemastine Fumarate market[4].

Environmental and Safety Regulations

The production and distribution of Clemastine Fumarate are subject to various environmental and safety regulations. Companies are focusing on producing high-quality and environmentally friendly products to comply with these regulations. This includes adherence to ESG (Environmental, Social, and Governance) standards, which are becoming increasingly important in the pharmaceutical industry[1].

Consumer Behavior Analysis

Consumer behavior plays a crucial role in the market dynamics of Clemastine Fumarate. There is an increasing demand for high-quality and effective treatments for allergic conditions, driving the growth of the market. Additionally, consumer awareness about the side effects of antihistamines and the preference for safer alternatives are factors that companies need to consider in their product development and marketing strategies[1].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry, including the market for Clemastine Fumarate. While the pandemic disrupted supply chains and manufacturing processes, it also accelerated the demand for certain pharmaceutical products due to increased healthcare needs. The market for Clemastine Fumarate has been relatively resilient, with continued demand for treatments of allergic conditions[1].

Key Takeaways

  • Growing Market Size: The global Clemastine Fumarate market is expected to grow significantly, driven by increasing demand and expanding applications.
  • Regional Growth: Asia Pacific and North America are key regions driving market growth.
  • Competitive Landscape: The market is competitive, with several key players and potential competition from biosimilars.
  • Technological Advancements: Advances in small molecule drugs and biosimilars are shaping the market.
  • Regulatory and Safety Considerations: Compliance with environmental and safety regulations is crucial.

FAQs

What is Clemastine Fumarate used for?

Clemastine Fumarate is used to treat various allergic conditions, including allergic rhinitis, conjunctivitis, dermatitis, eczema, pruritus, and urticaria[2][4].

Who are the key players in the Clemastine Fumarate market?

Key players include Sekisui Medical, Shandong Keyuan Pharmaceutical, GSK Plc, Sanofi, and Bayer AG[1][4].

What are the major drivers of the Clemastine Fumarate market?

The major drivers include the increasing prevalence of allergic conditions, technological advancements, and favorable regulatory environments[1][4].

What are the potential restraints to the Clemastine Fumarate market?

Potential restraints include competition from biosimilars, regulatory challenges, and safety concerns related to side effects[2][4].

How is the COVID-19 pandemic impacting the Clemastine Fumarate market?

The pandemic has had a mixed impact, with disruptions in supply chains but also increased demand for certain pharmaceutical products, making the market relatively resilient[1].

Sources

  1. Global Clemastine Fumarate Market Report 2024 Edition, Cognitivemarketresearch.com
  2. Clemastine: Uses, Interactions, Mechanism of Action, DrugBank
  3. Supreme Court of the United States, SupremeCourt.gov
  4. Clemastine Fumarate's R&D Progress and its Mechanism of Action, Synapse.patsnap.com
  5. Ubiquinol preserves immune cells in gamma-irradiated rats, ScienceDirect.com

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