EFIDAC 24 CHLORPHENIRAMINE MALEATE Drug Patent Profile

Which patents cover Efidac 24 Chlorpheniramine Maleate, and what generic alternatives are available?

Efidac 24 Chlorpheniramine Maleate is a drug marketed by Alza and is included in one NDA.

The generic ingredient in EFIDAC 24 CHLORPHENIRAMINE MALEATE is chlorpheniramine maleate. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Efidac 24 Chlorpheniramine Maleate

A generic version of EFIDAC 24 CHLORPHENIRAMINE MALEATE was approved as chlorpheniramine maleate by AVANTHI INC on May 13^th, 2009.

Summary for EFIDAC 24 CHLORPHENIRAMINE MALEATE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	3,832
DailyMed Link:	EFIDAC 24 CHLORPHENIRAMINE MALEATE at DailyMed

US Patents and Regulatory Information for EFIDAC 24 CHLORPHENIRAMINE MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994		DISCN	No	No

Expired US Patents for EFIDAC 24 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
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994

International Patents for EFIDAC 24 CHLORPHENIRAMINE MALEATE

See the table below for patents covering EFIDAC 24 CHLORPHENIRAMINE MALEATE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H0784385
Australia	597952
Germany	3766885

Market Dynamics and Financial Trajectory for EFIDAC 24 CHLORPHENIRAMINE MALEATE

Last updated: July 27, 2025

Introduction

EFIDAC 24 Chlorpheniramine Maleate, a proprietary antihistamine formulation, holds a significant position within the allergy and cold relief segment. As a first-generation antihistamine, it primarily addresses allergic rhinitis, cold symptoms, and related conditions. This analysis explores the evolving market landscape, regulatory considerations, competitive forces, and projected financial trajectories influencing EFIDAC 24 Chlorpheniramine Maleate’s market performance.

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Market Overview

The global antihistamine market is characterized by steady growth, driven by rising prevalence of allergic diseases, increasing awareness, and expanding healthcare infrastructure. According to Global Market Insights, the antihistamines market was valued at over USD 6 billion in 2020, with a compound annual growth rate (CAGR) projected at approximately 4.2% from 2021 to 2027. EFIDAC 24 Chlorpheniramine Maleate, as a generic or branded therapeutic, benefits from its established efficacy, affordable pricing, and widespread availability.

Therapeutic Segment Drivers

• Prevalence of Allergic Rhinitis and Cold Symptoms: Epidemiological data suggest that allergic rhinitis affects up to 30% of adults and 40% of children globally, propelling demand for antihistaminic agents such as chlorpheniramine [1].
• Aging Population: Older demographics exhibit increased susceptibility to allergic and respiratory conditions, augmenting market size.
• OTC Availability: The over-the-counter accessibility of chlorpheniramine formulations increases consumer demand, especially in emerging markets.

Geographical Trends

• North America & Europe: Mature markets with high consumer awareness, regulatory clarity, and branded drug dominance.
• Asia-Pacific: Rapidly growing markets with multiple manufacturing hubs, driven by urbanization, lifestyle changes, and expanding healthcare access.

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Regulatory Landscape and Patent Considerations

While EFIDAC 24 Chlorpheniramine Maleate operates largely within the generic segment, regulatory approvals significantly influence market dynamics.

• Regulatory Approvals: The molecule’s longstanding approval status simplifies entry, but variations in formulations and indications may require localized registration.
• Patent Status: Original patents on chlorpheniramine have expired globally over the past two decades, enabling generic entry. However, specific formulations like EFIDAC 24 may be protected by secondary patents or proprietary manufacturing processes, influencing exclusivity periods [2].

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Competitive Landscape

Market Entrants

Numerous pharmaceutical companies manufacture chlorpheniramine-based products, with differentiation primarily through branding, formulation, and pricing strategies.

Brand vs. Genric Competition

• Brand players leverage marketing and clinical efficacy claims.
• Generics benefit from price competitiveness and broader distribution channels, especially in emerging economies.

Innovation and Product Differentiation

While innovation in chlorpheniramine formulations is limited due to its long-established usage, value-added features such as combination therapies, extended-release formulations, and improved tolerability are emerging trends to capture market share.

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Pricing and Market Penetration Strategies

Price sensitivity varies geographically:

• Developed Markets: Lower price elasticity, with preference toward brand trust and clinical reputation.
• Emerging Markets: High price sensitivity, driven by OTC channel dynamics and affordability concerns.

Effective penetration strategies include strategic alliances with local distributors, competitive pricing, and awareness campaigns highlighting safety and efficacy.

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Financial Trajectory and Revenue Forecasts

Historical Performance

While specific sales data for EFIDAC 24 Chlorpheniramine Maleate are proprietary, the broader antihistamine segment has experienced consistent growth. The global antihistamine market’s CAGR of approximately 4.2% from 2021-2027 indicates sustained revenue expansion.

Projected Growth Factors

• Market Expansion: Emerging markets are expected to account for over 50% of growth, owing to increasing allergy prevalence and healthcare access.
• Regulatory Acceptance: Simplified registration processes and regulatory harmonization facilitate market entry.
• Product Line Extensions: Developing combination therapies and novel formulations can unlock incremental revenues.

Forecast Models

Assuming a conservative CAGR of 4%, revenues for EFIDAC 24 Chlorpheniramine Maleate are projected to grow in tandem with the broader market. For instance, if the current annual sales are estimated at USD 50 million, revenues could reach approximately USD 65 million over five years, contingent on successful market expansion and competitive positioning.

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Challenges and Risks

• Market Saturation: High competition and widespread generic availability may suppress margins.
• Patent and Regulatory Barriers: Emerging regional rules or secondary patent protections could delay or limit market expansion.
• Consumer Preferences: Rising preference for second-generation antihistamines with fewer sedative effects could reduce demand.

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Strategic Outlook

To capitalize on growth opportunities:

• Geographical Diversification: Focus on high-growth regions like Asia-Pacific and Latin America.
• Product Innovation: Explore combination therapies targeting multiple allergy symptoms.
• Regulatory Engagement: Ensure timely approval processes to sustain market access.
• Pricing Strategies: Balance affordability with profitability, especially in price-sensitive markets.

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Key Takeaways

• EFIDAC 24 Chlorpheniramine Maleate operates within a stable, growing antihistamine market driven by increasing allergy prevalence worldwide.
• Market expansion in emerging economies offers significant revenue opportunities, contingent on competitive pricing and distribution strategies.
• Patent expirations on chlorpheniramine facilitate generic proliferation, intensifying competitive pressures.
• Innovations such as combination therapies and extended-release formulations may improve market share and financial performance.
• Strategic positioning, regulatory agility, and market diversification are critical to sustaining positive financial trajectory.

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FAQs

1. What factors influence the pricing of EFIDAC 24 Chlorpheniramine Maleate in different regions?
Pricing is affected by market competition, regulatory policies, healthcare infrastructure, consumer purchasing power, and local demand-supply dynamics.

2. How does patent expiry impact the market for chlorpheniramine-based products?
Patent expiry leads to increased generic competition, driving down prices but simultaneously expanding the overall market size as affordability improves and access widens.

3. What are potential growth opportunities for EFIDAC 24 Chlorpheniramine Maleate?
Growth opportunities include expanding into new geographical markets, developing combination therapies, and improving formulations to enhance patient compliance.

4. What challenges could impede the financial growth of EFIDAC 24?
Challenges include market saturation, regulatory hurdles, consumer shift towards second-generation antihistamines, and commoditization pressures from generic competitors.

5. How important is regulatory compliance for sustaining revenue growth?
Regulatory compliance is critical; delayed approvals or non-compliance can restrict market access, impacting sales and profitability.

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Sources

[1] Global Market Insights. “Antihistamines Market Size, Share & Industry Analysis.” 2021.
[2] U.S. Patent Office. “Patent Life and Expirations of Chlorpheniramine.” 2022.