Chlorpheniramine maleate - Generic Drug Details

What are the generic drug sources for chlorpheniramine maleate and what is the scope of patent protection?

Chlorpheniramine maleate is the generic ingredient in twenty-three branded drugs marketed by Aurolife Pharma Llc, Glaxosmithkline, Schering Plough, Bel Mar, Elkins Sinn, Watson Labs, Schering, Pharm Assoc, Bayer Healthcare Llc, Avanthi Inc, Alza, Bayer Pharms, Anabolic, Bell Pharma, Impax Labs, Ivax Sub Teva Pharms, Kv Pharm, Lederle, Newtron Pharms, Panray, Pharmavite, Pharmeral, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Vitarine, West Ward, Halsey, Lannett, Mainpointe, Acella, Tris Pharma Inc, Persion, Mayne Pharma Inc, Padagis Us, Sciegen Pharms Inc, Haleon Us Holdings, Graham Dm, Novartis, Schwarz Pharma, Fisons, and Cent Pharms, and is included in sixty-two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for chlorpheniramine maleate. Two suppliers are listed for this compound.

Summary for chlorpheniramine maleate

US Patents:	4
Tradenames:	23
Applicants:	44
NDAs:	62
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	9
Patent Applications:	6,711
Drug Prices:	Drug price trends for chlorpheniramine maleate
What excipients (inactive ingredients) are in chlorpheniramine maleate?	chlorpheniramine maleate excipients list
DailyMed Link:	chlorpheniramine maleate at DailyMed

See drug prices for chlorpheniramine maleate

See drug sales revenues for chlorpheniramine maleate

Recent Clinical Trials for chlorpheniramine maleate

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

Sponsor	Phase
Dr. Ferrer BioPharma	Phase 2/Phase 3
Hospital CEMESA Cortés, San Pedro Sula, Honduras	Phase 2/Phase 3
Marcos Sanchez-Gonzalez, MD, PhD	Phase 2/Phase 3

See all chlorpheniramine maleate clinical trials

Pharmacology for chlorpheniramine maleate

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for chlorpheniramine maleate

Anti-Allergic Agents

Antipruritics

Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for chlorpheniramine maleate

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

R06AB	Substituted alkylamines
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for chlorpheniramine maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare Llc	CHLOR-TRIMETON	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	007638-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Graham Dm	PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate; pseudoephedrine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018843-001	Mar 18, 1985		DISCN	No	No
Bayer Healthcare Llc	CHLOR-TRIMETON	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	007638-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for chlorpheniramine maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994	4,576,604
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994	4,857,330
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994	4,673,405

Chlorpheniramine maleate Market Analysis and Financial Projection Experimental

Chlorpheniramine Maleate Market Dynamics and Financial Trajectory

Market Overview

The chlorpheniramine maleate market is a significant segment within the pharmaceutical industry, specializing in the treatment of allergic conditions. This market has been experiencing steady growth, driven by several key factors.

Market Size and Growth Projections

• The global chlorpheniramine maleate market was valued at approximately USD 471 million in 2022 and is projected to reach USD 744 million by 2032, growing at a CAGR of 4.8% from 2023 to 2032[1][4][5].
• Another estimate suggests the market size could reach USD 848.1 million by 2032, growing at a CAGR of 5.7% during the forecast period of 2024-2032[2].

Regional Market Dynamics

• North America: This region led the market in 2022, holding more than 38% of the market share. It is expected to remain dominant due to advanced healthcare infrastructure and a high prevalence of allergic conditions[1][4][5].
• Asia-Pacific: This region is anticipated to experience the highest growth rate, driven by an increase in allergic conditions, growing consumer awareness, and rising air pollution in countries like India, China, Japan, and South Korea[1][4].

Market Drivers

• Prevalence of Allergic Disorders: The escalating global incidence of allergic conditions, partly due to environmental changes and increased allergen exposure, is a significant driver for demand[2][4].
• Accessibility and Affordability: In emerging economies, the cost-effectiveness of chlorpheniramine maleate makes it a preferred choice over more expensive, second-generation antihistamines[2].
• Versatile Applications: Beyond allergies, its use in common cold preparations underscores its versatility, sustaining demand across diverse patient demographics[2].

Market Challenges

• Side Effect Profile: Sedation and drowsiness associated with first-generation antihistamines can deter users, especially those requiring daytime alertness[2][4].
• Regulatory Scrutiny: Tightening regulations regarding over-the-counter medications and their side effects pose challenges to market growth[2].
• Competition from Advanced Antihistamines: The development of newer, non-sedating antihistamines with longer-lasting effects presents a formidable challenge, shifting preferences among a segment of consumers[2].

Opportunities for Growth

• Innovation in Drug Formulation: Developing extended-release formulations or combination therapies could mitigate side effects while enhancing efficacy, opening new growth avenues[2].
• Expansion in Emerging Markets: Increasing healthcare access and affordability in developing regions provide fertile ground for market expansion, especially for cost-effective drugs like chlorpheniramine maleate[2].
• Increased Awareness and Self-Medication Trends: Growing health awareness and the trend towards self-medication for minor ailments can increase the over-the-counter sales of chlorpheniramine maleate[2].

Segmental Overview

• By Dosage Form: The injection segment contributed more than 41% of the revenue share in 2022, indicating a strong demand for injectable forms of the drug[1].
• By Application: The allergy segment is expected to expand at a significant CAGR during the forecast period, driven by the increasing prevalence of allergic conditions[1].

Competitive Landscape

• Key market players such as Capellon Pharmaceuticals, GlaxoSmithKline plc, Viatris Inc., Johnson & Johnson, Sun Pharmaceutical Industries Limited, and others are driving innovation and strategic market expansions[4].
• These companies are focusing on R&D activities to develop novel therapies with fewer side effects and greater efficacy, which is expected to provide lucrative opportunities for growth[4].

Financial Trajectory

• The market's financial trajectory is characterized by steady growth, with a projected CAGR ranging from 4.8% to 5.7% over the forecast period[1][2][4].
• The increasing demand for antihistamines, particularly in regions with rising allergic conditions, and the cost-effectiveness of chlorpheniramine maleate are key financial drivers[2].

Impact of External Factors

• COVID-19: The overall impact of COVID-19 on the chlorpheniramine maleate market has been positive, with increased healthcare needs and self-medication trends contributing to market growth[4].

Consumer Preferences and Trends

• There is a growing trend towards natural remedies and holistic approaches, which can hamper the growth of the chlorpheniramine maleate market. However, the established presence and cost-effectiveness of the drug continue to sustain its demand[4].

"Addressing challenges such as side effects and regulatory hurdles through innovation and strategic initiatives will be crucial for sustaining growth and leveraging emerging opportunities across the globe."[2]

Key Takeaways

• The chlorpheniramine maleate market is expected to grow significantly, driven by the increasing prevalence of allergic conditions and the cost-effectiveness of the drug.
• Innovation in drug formulation and expansion into emerging markets are key opportunities for growth.
• The market faces challenges from side effects and regulatory scrutiny but remains resilient due to its foundational role in treating allergies.
• North America and the Asia-Pacific region are expected to be major contributors to the market's growth.

Frequently Asked Questions (FAQs)

Q: What is the primary use of chlorpheniramine maleate? A: Chlorpheniramine maleate is an antiallergic medicine used in the treatment of various allergic conditions such as allergic rhinitis (hay fever), relieving symptoms like runny nose, sneezing, and itchy eyes[4].

Q: What are the key drivers of the chlorpheniramine maleate market? A: The key drivers include the increasing prevalence of allergic disorders, the cost-effectiveness of the drug, and its versatile applications[2].

Q: Which region is expected to dominate the chlorpheniramine maleate market? A: North America is expected to dominate the market, followed by significant growth in the Asia-Pacific region[1][4][5].

Q: What are the major challenges facing the chlorpheniramine maleate market? A: The major challenges include side effects such as sedation and drowsiness, regulatory scrutiny, and competition from advanced antihistamines[2].

Q: How is the market expected to grow in terms of financials? A: The market is projected to grow at a CAGR of 4.8% to 5.7% from 2023 to 2032, reaching a market size of USD 744 million to USD 848.1 million by 2032[1][2][4].

Sources:

1. GlobeNewswire: Chlorpheniramine Maleate Market is forecasted to Reach USD 744 Million by 2032[1].
2. ResearchAndMarkets: Chlorpheniramine Maleate Market Report and Forecast 2024-2032[2].
3. HTV10: Chlorpheniramine Maleate Market: Trends, Insights and Regional Dynamics in 2032[3].
4. Allied Market Research: Chlorpheniramine Maleate Market Statistics and Forecast - 2032[4].
5. IndustryARC: Chlorpheniramine Maleate Market - Forecast(2024 - 2030)[5].