EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE Drug Patent Profile

Which patents cover Efidac 24 Pseudoephedrine Hydrochloride/brompheniramine Maleate, and when can generic versions of Efidac 24 Pseudoephedrine Hydrochloride/brompheniramine Maleate launch?

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
DailyMed Link:	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE at DailyMed

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

Expired US Patents for EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996	4,662,880
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996	4,801,461
Alza	EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE	brompheniramine maleate; pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	019672-001	Mar 29, 1996	4,810,502

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
Austria	63059
Australia	601708
Australia	6740687

Market Dynamics and Financial Trajectory for EFIDAC 24 Pseudoephedrine Hydrochloride/Brompheniramine Maleate

Last updated: February 16, 2026

What is EFIDAC 24?

EFIDAC 24 combines pseudoephedrine hydrochloride and brompheniramine maleate. It is an over-the-counter (OTC) or prescription medication used primarily for relief from nasal congestion and allergy symptoms. Its formulation leverages pseudoephedrine for decongestant effects and brompheniramine as an antihistamine.

How is the market for combination cold and allergy medications evolving?

The market for OTC and prescription combination cold and allergy drugs is driven by increased consumer awareness and rising incidences of allergies and sinus conditions. The global cold, cough, and allergy (CCA) medications market was valued at approximately USD 15.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.2% through 2028 [1].

Key market drivers include:

• Aging populations with higher allergy prevalence, especially in North America and Europe.
• Rising urbanization, leading to increased exposure to pollutants.
• Consumer preference for combination products that simplify medication regimens.
• Regulatory shifts, including rescheduling of pseudoephedrine, impacting manufacturing and sales.

Market challenges:

• Stringent pseudoephedrine sales restrictions due to its use in illicit methamphetamine production.
• Competition from newer antihistamines and decongestants with better safety profiles.
• Growing consumer interest in natural and alternative medicines.

What are the regulatory considerations impacting EFIDAC 24?

Pseudoephedrine sales are heavily regulated under domestic laws in multiple regions. For example:

• In the U.S., the Combat Methamphetamine Epidemic Act (CMEA) restricts pseudoephedrine sales to behind-the-counter or via regulated logbooks.
• In the EU, pseudoephedrine is listed as a Class IIB substance, requiring controlled sale procedures.
• Canada classifies pseudoephedrine as a schedule 1 substance with similar restrictions.

These regulations influence supply chain logistics, shelf distribution, and pricing. Companies often adapt by reformulating or focusing on export markets with less restrictive laws.

How does competition shape the financial outlook?

The market's competitive landscape includes:

• Multi-symptom OTC combinations: cold and allergy tablets combining pseudoephedrine with antihistamines.
• Prescription-only formulations with enhanced safety profiles.
• Generic formulations offering lower price points.

Major players dominate: Johnson & Johnson (Benadryl), GSK (Zyrtec), and local manufacturers in specific regions. The presence of generics diminishes profit margins, impacting R&D investment and revenue potential.

What are the financial prospects for EFIDAC 24?

Current revenue figures for EFIDAC 24 are not publicly disclosed, but similar combination products generate annual sales in the hundreds of millions globally, with some markets reporting over USD 300 million in sales for similar branded products in 2022 [2].

Profit margins are potentially constrained:

• Price erosion from generics.
• Distribution costs increased by pseudoephedrine regulations.
• R&D expenses for reformulations and new delivery mechanisms.

Pharmaceutical companies that own patents for formulations or delivery methods could capitalize on market niches. Nevertheless, patent exclusivity for EFIDAC 24 may be limited due to the generic nature of its active ingredients.

What are the potential future trends?

• Shift toward sustained-release formulations improving patient compliance.
• Development of pseudoephedrine-free alternatives to circumvent regulatory restrictions.
• Increased investment in digital marketing to reach consumers directly.
• Expansion into emerging markets where regulatory frameworks are evolving.

Key Market Factors Summary Table

Factor	Impact	Details/Examples
Regulatory environment	Constraints	Pseudoephedrine restrictions reduce availability in some markets.
Consumer trends	Growth	Preference for combination OTC drugs for convenience.
Competition	Pressure	Generics and newer therapies reduce margins.
R&D focus	Innovation	Formulation improvements and alternative delivery systems.
Market size	Growth forecast	CAGR of 4.2% for CCA market through 2028.

What is the projected financial trajectory?

Given current market trends,

• Sales are expected to grow modestly in mature markets driven by aging populations.
• Regulatory hurdles may limit peak revenue potential.
• Companies investing in reformulation or alternative therapies can capture market share.
• In emerging markets, growth rates could surpass global averages due to less restrictive regulations.

The overall revenue for EFIDAC 24 specifically remains unclear, but the broader segment's incremental annual growth is forecasted to align with the 4.2% CAGR of the OTC CCA segment.

Key Takeaways

• The market for EFIDAC 24 is influenced by shifting regulations on pseudoephedrine and consumer preference for combination products.
• Competition from generic products limits profit margins but creates opportunities for innovative formulations.
• The global OTC cold and allergy medication market exhibits steady growth, with notable expansion in emerging regions.
• Future growth hinges on regulatory adaptations, formulation innovation, and strategic marketing.
• Companies with formulation patents or alternative delivery technologies could find advantageous positions.

FAQs

1. How do pseudoephedrine regulations affect EFIDAC 24 sales?
Restrictions limit OTC sales, requiring behind-the-counter access in many jurisdictions, which can reduce accessibility and sales volume.

2. Are there patent protections for EFIDAC 24?
Likely limited due to the generic status of its active ingredients. Patent protection may only apply to specific formulation methods or delivery systems.

3. What are the main competitors of EFIDAC 24?
Generic combination medications containing pseudoephedrine and brompheniramine, and branded products like Benadryl and Zyrtec with similar active ingredients.

4. Will innovation in delivery systems impact the market?
Yes. Sustained-release formulations and nasal delivery devices could shift market share, especially if they improve compliance or circumvent regulations.

5. What geographic regions offer the most growth potential?
Emerging markets such as Asia-Pacific and Latin America show higher growth rates due to less mature regulatory environments and increasing demand.

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References

[1] Grand View Research, "Cold and Allergy Medications Market Size, Share & Trends Analysis Report," 2022.

[2] IQVIA, "Pharmaceutical Market Data," 2022.

[3] U.S. Drug Enforcement Administration, "Pseudoephedrine Regulations," 2023.