EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE Drug Patent Profile

When do Efidac 24 Pseudoephedrine Hydrochloride/brompheniramine Maleate patents expire, and what generic alternatives are available?

Efidac 24 Pseudoephedrine Hydrochloride/brompheniramine Maleate is a drug marketed by Alza and is included in one NDA.

The generic ingredient in EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE is brompheniramine maleate; pseudoephedrine hydrochloride. There are twenty-one drug master file entries for this compound. Additional details are available on the brompheniramine maleate; pseudoephedrine hydrochloride profile page.

Summary for EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE 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 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996		DISCN	No	No

International Patents for EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE

See the table below for patents covering EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	602020
Germany	3407873
Norway	170667

Investment Scenario and Fundamentals Analysis for EFIDAC 24 Pseudoephedrine Hydrochloride/Brompheniramine Maleate

Last updated: February 4, 2026

Overview

EFIDAC 24 is a combination pharmaceutical product containing pseudoephedrine hydrochloride and brompheniramine maleate. It is primarily used to treat symptoms of seasonal allergic rhinitis and common cold, including nasal congestion and allergic symptoms. The drug targets a broad market, especially in regions with high prevalence of allergic and respiratory conditions.

Market Dynamics

1. Market Size and Growth

   The global antihistamine and decongestant market was valued at approximately $5.3 billion in 2022. Compound annual growth rate (CAGR) forecasted at 4-5% through 2027, driven by increasing prevalence of allergy-related conditions, aging populations, and expanding healthcare access in emerging markets.

2. Regional Adoption

   • North America possesses the largest share, driven by high awareness and purchasing power.

   • Asia-Pacific exhibits rapid growth, with increased demand and lower regulatory barriers.

   • Europe maintains steady growth, supported by aging demographics.

3. Regulatory Environment

   • Over-the-counter (OTC) classification in U.S., Canada, and parts of Europe simplifies distribution.

   • Strict scheduling and control especially for pseudoephedrine due to its precursor status for methamphetamine, influencing supply chain and inventory management.

Competitive Landscape

1. Key Players

   • Johnson & Johnson (Benadryl)

   • GlaxoSmithKline (Clarityn)

   • Sanofi (Allerfre, depending on formulation)

   • Generics manufacturers

2. Product Positioning

   EFIDAC 24 competes as a combination therapy offering rapid symptom relief. The presence of pseudoephedrine distinguishes it from newer antihistamines with non-centrally acting options, but regulatory scrutiny on pseudoephedrine poses risks.

3. Patent and Formulation Status

   • Likely lacks active patent protection due to age and widespread availability of generic equivalents.

   • Patent challenges or expiration could impact market exclusivity unless new formulations or delivery systems are introduced.

Regulatory and Supply Chain Considerations

• Pseudoephedrine’s classification as a List II controlled substance limits sales quantities and requires record-keeping, which can restrict production volumes.

• Brompheniramine generally faces fewer regulatory hurdles but must adhere to FDA monograph standards if marketed OTC.

• Manufacturing must ensure compliance with Good Manufacturing Practices (GMP) and secure necessary licenses for pseudoephedrine handling.

Financial Fundamentals

Metric	Data Point
Estimated annual market size	$500 million (global for combination pseudoephedrine/histamine formulations)
Manufacturing costs (per unit)	$0.10 - $0.20 (generic-level synthesis and packaging)
Retail price (average)	$1.00 - $3.00 per dose
Market share potential	1-2% in mature markets; 3-5% in emerging markets via strategic distribution

Risks and Barriers

• Regulatory scrutiny of pseudoephedrine significantly influences sales and distribution.
• Competition from non-prescription second-generation antihistamines reduces market penetration.
• Patent expiries threaten long-term exclusivity, increasing generic competition.
• Supply chain disruptions due to controls on pseudoephedrine precursor.

Investment Outlook

• Short-term: Entry through rapid distribution in high-demand regions can yield quick returns.
• Medium-term: Expansion into emerging markets and potential formulation innovation could sustain revenue growth.
• Long-term: Market saturation risk due to generic competition and regulatory restrictions.

Key Takeaways

• EFIDAC 24 operates in a competitive, regulated segment with high demand but faces significant market entry barriers and supply restrictions attributable to pseudoephedrine controls.
• Market growth remains favorable, especially in emerging regions, but profit margins are under pressure from rising generic competition.
• The product's success hinges on strategic distribution, regulatory compliance, and potential formulation innovations.

FAQs

1. What are the regulatory risks associated with EFIDAC 24?
   The pseudoephedrine component is a controlled substance, subject to strict sales limits and record-keeping requirements, which can complicate manufacturing and distribution.

2. How does market competition impact EFIDAC 24’s profitability?
   The widespread availability of generic combinations and newer antihistamines reduces pricing power and market share potential.

3. What opportunities exist for formulation innovation?
   Developing non-controlled or extended-release formulations may improve market access and patient compliance, offering competitive advantages.

4. Is patent protection relevant for EFIDAC 24?
   It likely lacks active patent protection, increasing exposure to generic competition unless new formulations are introduced.

5. Which markets offer the highest growth potential?
   Emerging markets in Asia-Pacific, Latin America, and Africa, where allergy prevalence rises and regulation is less restrictive, present notable opportunities.

Sources

[1] Grand View Research, "Antihistamines Market Size & Trends Analysis," 2022.
[2] U.S. Food and Drug Administration, "Pseudoephedrine Sales Regulations," 2022.
[3] IQVIA Institute, "Global Over-the-Counter Market Report," 2022.
[4] MBG Pharmaceutical Reports, "Market Dynamics of Combination Cold and Allergy Medications," 2022.