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Last Updated: December 22, 2024

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for chlorpheniramine maleate; pseudoephedrine hydrochloride and what is the scope of freedom to operate?

Chlorpheniramine maleate; pseudoephedrine hydrochloride is the generic ingredient in three branded drugs marketed by Schwarz Pharma, Fisons, Cent Pharms, Graham Dm, and Kv Pharm, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Summary for CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
US Patents:0
Tradenames:3
Applicants:5
NDAs:6
Clinical Trials: 2
DailyMed Link:CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE at DailyMed
Recent Clinical Trials for CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

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

SponsorPhase
Sino-American Tianjin Smith Kline & French Laboratories LtdPhase 4
GlaxoSmithKlinePhase 4
Magna Pharmaceuticals, Inc.Phase 3

See all CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Graham Dm PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018844-001 Mar 20, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Graham Dm PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018843-001 Mar 18, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Schwarz Pharma CODIMAL-L.A. 12 chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018935-001 Apr 15, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Cent Pharms PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 019428-001 Aug 2, 1988 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Kv Pharm PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 071455-001 Mar 1, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fisons ISOCLOR chlorpheniramine maleate; pseudoephedrine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 018747-001 Mar 6, 1986 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

CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride Market Dynamics and Financial Trajectory

Overview of Chlorpheniramine Maleate and Pseudoephedrine Hydrochloride

Chlorpheniramine maleate and pseudoephedrine hydrochloride are commonly used in combination to treat various allergic conditions and respiratory ailments. Chlorpheniramine maleate is an antihistamine that blocks the action of histamine, providing relief from symptoms such as sneezing, runny nose, itchy eyes, and throat irritation. Pseudoephedrine hydrochloride is a decongestant that helps reduce nasal congestion associated with colds and allergies.

Market Size and Growth

The global chlorpheniramine maleate market, which includes products combining chlorpheniramine maleate with other ingredients like pseudoephedrine hydrochloride, has been experiencing steady growth.

  • As of 2022, the global chlorpheniramine maleate market was valued at approximately $468.6 million and is projected to reach $751.4 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 4.9% from 2023 to 2032[1].
  • Another estimate suggests the market size was around $501.6 million in 2022 and is expected to grow to $780.2 million by 2032, with a CAGR of 5.2% from 2023 to 2032[4].

Regional Market Dynamics

North America

  • North America accounted for the majority share of the chlorpheniramine maleate market in 2022 and is expected to remain dominant during the forecast period. This is due to the region's advanced healthcare infrastructure, easy access to over-the-counter (OTC) medications, and an increase in the prevalence of allergic conditions[1][3].

Europe

  • Europe is also a significant market for chlorpheniramine maleate, driven by a well-established healthcare system and a high awareness of allergy management. The region's market is expected to continue growing, albeit at a slightly lower rate compared to North America[1][3].

Asia-Pacific

  • The Asia-Pacific region is anticipated to witness the highest growth rate during the forecast period. Factors contributing to this growth include the rising prevalence of allergic conditions, increasing consumer awareness about allergies, and the growing presence of key market players in countries such as India, China, Japan, and South Korea. Additionally, the surge in the geriatric population and increased air pollution in these countries are driving the demand for antihistamines like chlorpheniramine maleate[1][3].

Latin America and Middle East & Africa

  • Latin America and the Middle East & Africa are also experiencing growth, driven by improving healthcare infrastructure and increasing knowledge of allergy management. These regions are expected to grow at a CAGR of 4.4% and 4.7%, respectively, from 2023 to 2030[3].

Distribution Channels

  • The market for chlorpheniramine maleate is distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. The convenience and accessibility of OTC medications at retail pharmacies have significantly contributed to the market's growth[4].

Competitive Analysis

  • The chlorpheniramine maleate market is competitive, with key players such as Capellon Pharmaceuticals, GlaxoSmithKline plc, Viatris Inc., Johnson & Johnson, Sun Pharmaceutical Industries Limited, Zydus Lifesciences Limited, Novalab Healthcare Pvt. Ltd., Merck & Co., Inc., Alkem Laboratories Ltd., and Bayer AG. These companies are involved in various strategies including partnerships, acquisitions, and research collaborations to drive product innovation and market expansion[1][4].

Drivers of Market Growth

  • Increasing Prevalence of Allergic Conditions: The rise in allergic disorders such as hay fever, allergic rhinitis, and urticaria is a significant driver of the market. This increase is partly due to factors like urbanization, changing lifestyles, and increased air pollution[1][3].
  • Advancements in Healthcare: Improvements in healthcare infrastructure and easy access to healthcare services, including OTC medications, are boosting the market. The proactive response to allergic reactions in regions like North America further fuels the growth[1][3].
  • Geriatric Population: The surge in the geriatric population, who are more prone to allergic conditions, is another key driver. Older adults often require more frequent and effective treatments, contributing to the market's expansion[1][3].

Restraints and Challenges

  • Potential Side Effects: Chlorpheniramine maleate can have side effects such as drowsiness, dry mouth, blurred vision, and urinary retention, which can hamper market growth. The availability of alternative medications also poses a challenge[1].
  • Regulatory and Safety Concerns: The need for post-marketing surveillance and risk management plans, especially for combination products like ZUTRIPRO (containing hydrocodone bitartrate, chlorpheniramine maleate, and pseudoephedrine hydrochloride), can add complexity and costs to market operations[2].

Financial Trajectory

  • The financial trajectory of the chlorpheniramine maleate market is positive, with projected growth rates indicating a significant increase in market value over the next decade.
  • The market is expected to grow from approximately $468.6 million in 2022 to $751.4 million by 2032, or from $501.6 million to $780.2 million by 2032, depending on the source[1][4].

Key Takeaways

  • The chlorpheniramine maleate market is driven by the increasing prevalence of allergic conditions, advancements in healthcare, and the growing geriatric population.
  • North America and Europe are the dominant regions, but the Asia-Pacific region is expected to grow at the highest rate.
  • The market faces challenges from potential side effects and the availability of alternative medications.
  • Distribution through retail pharmacies and online channels is crucial for market growth.
  • Key players are engaging in partnerships, acquisitions, and research collaborations to drive innovation and expansion.

FAQs

What is chlorpheniramine maleate used for?

Chlorpheniramine maleate is an antihistamine used to treat various allergic conditions such as allergic rhinitis (hay fever), relieving symptoms like sneezing, itchy nose or throat, and runny nose caused by allergies and the common cold[1].

What are the potential side effects of chlorpheniramine maleate?

Potential side effects include drowsiness, dry mouth, blurred vision, and urinary retention. These side effects can hamper market growth and necessitate careful monitoring[1][2].

Which regions are expected to drive the growth of the chlorpheniramine maleate market?

North America is currently the dominant region, but the Asia-Pacific region is expected to witness the highest growth rate due to rising prevalence of allergic conditions and increasing consumer awareness about allergies[1][3].

How does the distribution channel impact the market?

The market is significantly influenced by distribution through retail pharmacies and online channels, which provide convenient and accessible options for consumers, contributing to the market's growth[4].

What are the key drivers of the chlorpheniramine maleate market?

Key drivers include the increasing prevalence of allergic conditions, advancements in healthcare infrastructure, and the growing geriatric population. These factors contribute to the rising demand for chlorpheniramine maleate[1][3].

Sources

  1. Allied Market Research: Chlorpheniramine Maleate Market Statistics and Forecast - 2032.
  2. FDA: ZUTRIPRO Oral Solution Clinical Review.
  3. Cognitive Market Research: Global Chlorpheniramine Maleate Market Report.
  4. Custom Market Insights: Global Chlorpheniramine Maleate Market Size, Share 2032.

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