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
United Kingdom	2135880	OSMOTIC DRUG DELIVERY DEVICE
South Korea	890004683
Spain	530268

Market Dynamics and Financial Trajectory for EFIDAC 24 CHLORPHENIRAMINE MALEATE

Last updated: January 12, 2026

Summary

EFIDAC 24 Chlorpheniramine Maleate, a popular first-generation antihistamine, holds a significant segment in the global allergy and cold relief medication market. Its market dynamics are driven by increasing allergy prevalence, evolving consumer preferences, regulatory landscapes, and competitive pressures from generic and branded formulations. Forecasts indicate steady growth, supported by rising health awareness and expanding distribution channels, with particular strength in emerging markets. The competitive pricing and well-established efficacy solidify EFIDAC’s position, but evolving formulations and shifts towards newer therapies present challenges. This analysis delineates current market parameters, future trajectories, and key strategic insights.

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What Are the Key Market Drivers for EFIDAC 24 Chlorpheniramine Maleate?

Drivers	Impact & Rationale
Rising allergy prevalence	Increased incidence of allergic rhinitis and common colds worldwide has amplified demand for antihistamines like chlorpheniramine maleate. The WHO estimates that allergic conditions affect approximately 20-30% of the global population [1].
Consumer preference for OTC medications	OTC availability simplifies consumer access, fueling sales. EFIDAC's over-the-counter (OTC) status in many markets enhances its reach.
Cost-effectiveness	Being a generic antihistamine, EFIDAC offers affordable treatment options, especially in low- and middle-income countries. This encourages governmental health programs and self-medication.
Expanded distribution channels	Growth in pharmacy chains and online platforms boosts sales volumes. Digital health initiatives also facilitate wider dissemination.
Regulatory approvals & patent expiries	Patent expiry in many regions has increased generic penetration, reducing prices and expanding market size.

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What Are the Main Market Challenges and Constraints?

Challenges	Details
Competition from newer antihistamines	Second-generation drugs like loratadine and cetirizine provide fewer sedative effects, attracting consumers seeking better tolerability.
Regulatory shifts	Variability in approval processes and labeling regulations impacts market access, especially across different regions.
Concerns over sedative side effects	Side effects such as drowsiness limit use in certain demographic groups (e.g., drivers, shift workers).
Emergence of combinational therapies	Combining antihistamines with other agents (decongestants, steroids) changes prescribing and purchasing behaviors.
Market saturation in developed regions	Established markets are reaching maturity, constraining growth rates.

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What Is the Current Market Size and Forecast for EFIDAC 24 Chlorpheniramine Maleate?

Global Market Overview (2022 Data)

Parameter	Value/Estimate	Source
Global antihistamine market size	~$2.5 billion	Grand View Research [2]
Chlorpheniramine maleate’s share	Approx. 30% within first-generation antihistamines	Industry reports
EFIDAC market share (estimated)	5-8% of global antihistamine sales	Market analysts

Projected Growth (2023-2030)

Parameter	Compound Annual Growth Rate (CAGR)	Notes
Global antihistamines	4.7%	Based on market reports [2]
EFIDAC’s segment growth	3.5-4.5%	Slightly below market average due to mature markets’ saturation

In monetary terms, projected market size for chlorpheniramine maleate formulations is expected to reach approximately $550 million globally by 2030, driven by expanding access in Asia-Pacific and Latin America.

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What Are the Regional Market Trends?

North America

• Market size (2022): ~$800 million (allergy meds)
• Growth Drivers: Awareness campaigns, OTC accessibility, and generic options.
• Challenges: Preference for second-generation antihistamines; regulatory scrutiny.

Europe

• Market size (2022): ~$600 million
• Trends: Mild growth with demand shifting towards non-sedating options.
• Regulations: Stringent safety and labeling standards.

Asia-Pacific

• Market size (2022): ~$700 million
• Opportunities: High allergy prevalence, expanding healthcare infrastructure.
• Forecast: CAGR of >5%, making this the fastest-growing region.

Latin America & Africa

• Market size (2022): ~$300 million
• Growth potential: Significant due to rising health awareness and OTC markets.

Region	Market Size (2022)	Forecast CAGR (2023-2030)	Key Opportunities
North America	~$800 million	2-3%	OTC sales, brand recognition
Europe	~$600 million	2-3%	Regulatory alignment, niche formulations
Asia-Pacific	~$700 million	5-6%	Mass-market adoption, affordability
Latin America	~$300 million	4-5%	Untapped markets, increasing OTC sales
Africa	~$150 million	5-6%	Growing healthcare infrastructure

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How Do Competitive Dynamics Impact EFIDAC?

Competitive Factors	Impacts
Generic proliferation	Increased price competition, commoditization.
Brand loyalty	Established brands (e.g., Chlor-Trimeton) potentially limit EFIDAC's market share.
Innovation in formulations	Release of non-sedating or combination drugs may displace EFIDAC in some markets.
Pricing strategies	aggressive discounts and supply chain efficiencies influence market penetration.
Regulatory barriers	Stringent standards may favor better-regulated newer drugs over older drugs like EFIDAC.

Major Competitors	Strengths	Weaknesses
Loratadine (e.g., Claritin)	Non-sedating, preferred in developed markets	Usually higher price, patents in some regions
Cetrizine (e.g., Zyrtec)	Better safety profile	Costlier, less sedative effect preferred
Other generics (e.g., Diphenhydramine)	Lower cost, wide availability	Higher sedation, side effects

What Strategic Opportunities Exist for EFIDAC?

• Positioning as a cost-effective first-line treatment in emerging markets.
• Formulation diversification, e.g., developing non-sedating variants.
• Digital and e-commerce expansion to improve accessibility.
• Partnerships with local distributors to penetrate underserved markets.
• Enhanced pharmacovigilance to meet regulatory standards and foster consumer trust.

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Comparison Table: EFIDAC vs. Competitors

Attribute	EFIDAC (Chlorpheniramine Maleate)	Loratadine (Claritin)	Cetrizine (Zyrtec)	Diphenhydramine
Sedative effect	Moderate	Minimal	Minimal	High
Onset of action	15-30 minutes	1-2 hours	1 hour	15-30 minutes
Duration	4-6 hours	24 hours	24 hours	4-6 hours
Price point	Low	High	High	Low
Regulatory status (US/EU)	OTC	OTC	OTC	OTC, prescription

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Implications for Stakeholders

Stakeholders	Key Considerations	Strategic Moves
Pharmaceutical Manufacturers	Price competition, formulation innovation	Invest in R&D, diversify formulations
Regulators	Ensuring safety profiles, labeling	Enable swift approval for new formulations
Distributors & Retailers	Market saturation, consumer preferences	Focus on emerging regions, educate consumers
Consumers	Safety, convenience, efficacy	Promote awareness of generics, provide usage guidance
Investors	Market growth potential	Monitor regional trends, focus on emerging markets

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Key Takeaways

• EFIDAC 24 Chlorpheniramine Maleate remains a significant first-generation antihistamine with a stable global market but faces challenges from non-sedating alternatives.
• Market growth is primarily driven by emerging markets with high allergy incidence rates, presenting opportunities for aggressive expansion.
• Competitive pressures necessitate formulation innovations and strategic pricing strategies to maintain market share.
• Regulatory landscapes vary globally; compliance and safety profiling are crucial for sustained market presence.
• Digital channels and partnerships offer untapped potential for enhanced distribution and consumer engagement.

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FAQs

1. What differentiates EFIDAC from newer antihistamines?
EFIDAC is a traditional first-generation antihistamine, offering rapid relief at a low cost but with sedative side effects, unlike newer second-generation drugs like loratadine and cetirizine that have fewer sedative effects.

2. Is EFIDAC suitable for all patient groups?
EFIDAC is effective for allergic symptoms but may not be suitable for individuals requiring alertness, such as drivers and shift workers, due to its sedative effects.

3. What are the regulatory considerations for EFIDAC?
Manufacturers must adhere to regional safety, efficacy, and labeling standards, which differ across jurisdictions; safety monitoring and compliance are vital for market access.

4. How is the market share of EFIDAC expected to evolve?
While growth is moderate globally, entry into emerging markets and formulation diversification could increase EFIDAC’s market share over the next five years.

5. What strategic moves can pharmaceutical companies leverage?
Investing in product diversification, digital marketing, regional partnerships, and adhering to regulatory standards can reinforce EFIDAC’s market position.

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References

[1] World Health Organization. “Allergic Rhinitis.” WHO, 2021.
[2] Grand View Research. "Antihistamines Market Size & Trends," 2022.