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Last Updated: December 22, 2024

DEXCHLORPHENIRAMINE MALEATE - Generic Drug Details


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What are the generic drug sources for dexchlorpheniramine maleate and what is the scope of freedom to operate?

Dexchlorpheniramine maleate is the generic ingredient in three branded drugs marketed by Pai Holdings Pharm, Schering, Capellon Pharms Llc, and Ani Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for dexchlorpheniramine maleate. One supplier is listed for this compound.

Summary for DEXCHLORPHENIRAMINE MALEATE
US Patents:0
Tradenames:3
Applicants:4
NDAs:5
Drug Master File Entries: 6
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 60
Clinical Trials: 5
Patent Applications: 2,490
What excipients (inactive ingredients) are in DEXCHLORPHENIRAMINE MALEATE?DEXCHLORPHENIRAMINE MALEATE excipients list
DailyMed Link:DEXCHLORPHENIRAMINE MALEATE at DailyMed
Recent Clinical Trials for DEXCHLORPHENIRAMINE MALEATE

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

SponsorPhase
EMSPhase 3
Mantecorp Industria Quimica e Farmaceutica Ltd.Phase 3

See all DEXCHLORPHENIRAMINE MALEATE clinical trials

US Patents and Regulatory Information for DEXCHLORPHENIRAMINE MALEATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms DEXCHLORPHENIRAMINE MALEATE dexchlorpheniramine maleate TABLET;ORAL 088682-001 Jan 17, 1986 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Schering POLARAMINE dexchlorpheniramine maleate TABLET;ORAL 086835-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pai Holdings Pharm DEXCHLORPHENIRAMINE MALEATE dexchlorpheniramine maleate SYRUP;ORAL 088251-001 Mar 23, 1984 DISCN Yes 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

DEXCHLORPHENIRAMINE MALEATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dexchlorpheniramine Maleate

Introduction to Dexchlorpheniramine Maleate

Dexchlorpheniramine maleate is a small molecule drug that primarily targets the H1 receptor, playing a crucial role in mediating allergic responses. Approved for use in various therapeutic areas, including immune system diseases, infectious diseases, eye diseases, skin and musculoskeletal diseases, respiratory diseases, and otorhinolaryngologic diseases, this drug has been a staple in allergy treatment since its first approval in Japan in 1964[2].

Market Size and Growth Projections

The market for dexchlorpheniramine maleate, closely related to the broader antihistamine market, is expected to experience significant growth over the coming years.

  • Global Market Size: The chlorpheniramine maleate market, which includes dexchlorpheniramine maleate, was valued at $468.6 million in 2022 and is projected to reach $751.4 million by 2032, growing at a CAGR of 4.9% from 2023 to 2032[1].
  • Broader Antihistamine Market: The human antihistamine drug market, which encompasses dexchlorpheniramine maleate, is expected to grow from $274.8 million in 2023 to $706.2 million by 2033, at a CAGR of 9.9%[4].

Key Drivers of Market Growth

Several factors are driving the growth of the dexchlorpheniramine maleate market:

  • Rise in Allergic Conditions: The increasing prevalence of allergies and related respiratory conditions such as allergic rhinitis, urticaria, and vasomotor rhinitis is a significant driver. These conditions are becoming more common due to environmental factors, urbanization, and changing lifestyles[1][3].
  • Advancements in Healthcare: Improvements in healthcare infrastructure, particularly in regions like North America and emerging economies such as India and China, have made antihistamines more accessible. This ease of access to healthcare services, including over-the-counter (OTC) medications, is boosting market growth[1][3].
  • R&D Activities: Ongoing research and development activities aimed at creating novel therapies with fewer side effects and greater efficacy are expected to provide lucrative opportunities for the market[1].

Geographical Analysis

The market for dexchlorpheniramine maleate is geographically diverse, with different regions contributing significantly:

  • North America: This region accounted for the majority share in 2022 and is anticipated to remain dominant during the forecast period. The high prevalence of allergic conditions and advanced healthcare infrastructure contribute to this dominance[1][3].
  • Asia-Pacific: This region is expected to witness the highest growth rate due to the rising prevalence of allergic conditions, increasing consumer awareness, and a surge in the geriatric population. Countries like India, China, Japan, and South Korea are key contributors to this growth[1].

Market Restraints

Despite the positive growth trajectory, there are several factors that could hamper the market:

  • Side Effects: Potential side effects of dexchlorpheniramine maleate, such as drowsiness, dry mouth, blurred vision, and urinary retention, can deter some consumers[1][3].
  • Shift to Alternative Medicines: Changes in consumer preferences towards natural remedies and holistic approaches can also restrain market growth[1].

Competitive Landscape

The market for dexchlorpheniramine maleate is competitive, with several key players:

  • Major Players: Companies such as GlaxoSmithKline plc, Viatris Inc., Johnson & Johnson, Sun Pharmaceutical Industries Limited, and Bayer AG hold significant market positions. These companies are involved in continuous R&D to improve the efficacy and safety of antihistamines[1].

Therapeutic Applications

Dexchlorpheniramine maleate is versatile in its therapeutic applications:

  • Allergic Conditions: It is used to treat allergic rhinitis, vasomotor rhinitis, urticaria, and allergic conjunctivitis. The drug alleviates symptoms such as itching, inflammation, and nasal congestion[2].
  • Other Diseases: It is also indicated for immune system diseases, infectious diseases, eye diseases, skin and musculoskeletal diseases, and otorhinolaryngologic diseases[2].

Historical Significance and Safety Profile

Dexchlorpheniramine maleate has a long history of safe use since its first approval in 1964. Its approval in multiple countries and extensive use worldwide attest to its safety and efficacy profile[2].

Impact of COVID-19

The COVID-19 pandemic had a positive impact on the chlorpheniramine maleate market, including dexchlorpheniramine maleate. The increased focus on healthcare and the rise in allergic reactions during the pandemic contributed to the market's growth[1].

Key Takeaways

  • The dexchlorpheniramine maleate market is driven by the increasing prevalence of allergic conditions and advancements in healthcare infrastructure.
  • North America is the dominant region, but Asia-Pacific is expected to grow at the highest rate.
  • The market faces restraints due to potential side effects and a shift towards alternative medicines.
  • Key players are investing in R&D to improve the safety and efficacy of antihistamines.
  • Dexchlorpheniramine maleate has a broad range of therapeutic applications and a strong safety profile.

Frequently Asked Questions (FAQs)

1. What is dexchlorpheniramine maleate used for? Dexchlorpheniramine maleate is used to treat various allergic conditions, including allergic rhinitis, urticaria, and allergic conjunctivitis. It also alleviates symptoms associated with bites and stings, dermatitis, and other skin conditions[2].

2. What are the potential side effects of dexchlorpheniramine maleate? Potential side effects include drowsiness, dry mouth, blurred vision, and urinary retention[1][3].

3. Which region dominates the dexchlorpheniramine maleate market? North America dominates the market due to advanced healthcare infrastructure and a high prevalence of allergic conditions[1][3].

4. How is the market for dexchlorpheniramine maleate expected to grow? The market is expected to grow at a CAGR of 4.9% from 2023 to 2032, reaching $751.4 million by 2032[1].

5. What are the key factors restraining the growth of the dexchlorpheniramine maleate market? Key restraints include potential side effects and a shift in consumer preferences towards alternative medicines[1].

Cited Sources:

  1. Allied Market Research - Chlorpheniramine Maleate Market Statistics and Forecast - 2032[1]
  2. Synapse - Unleashing the Power of Dexchlorpheniramine Maleate[2]
  3. IndustryARC - Chlorpheniramine Maleate Market - Forecast(2024 - 2030)[3]
  4. Market.US - Human Antihistamine Drug Market Size | CAGR OF 9.9%[4]

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