SUDAFED 24 HOUR Drug Patent Profile

When do Sudafed 24 Hour patents expire, and what generic alternatives are available?

Sudafed 24 Hour is a drug marketed by Kenvue Brands and is included in one NDA.

The generic ingredient in SUDAFED 24 HOUR is pseudoephedrine hydrochloride. There are forty-nine drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sudafed 24 Hour

A generic version of SUDAFED 24 HOUR was approved as pseudoephedrine hydrochloride by L PERRIGO CO on February 26^th, 1999.

Summary for SUDAFED 24 HOUR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
Patent Applications:	1,684
DailyMed Link:	SUDAFED 24 HOUR at DailyMed

Recent Clinical Trials for SUDAFED 24 HOUR

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

Sponsor	Phase
John Muir Health	N/A
Vanderbilt University	Early Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1

See all SUDAFED 24 HOUR clinical trials

US Patents and Regulatory Information for SUDAFED 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kenvue Brands	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992		DISCN	Yes	No

Expired US Patents for SUDAFED 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992	4,576,604
Kenvue Brands	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992	4,801,461

International Patents for SUDAFED 24 HOUR

See the table below for patents covering SUDAFED 24 HOUR around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	8401185
Mexico	165227	UN DISPOSITIVO OSMOTICO PARA SUMINISTRAR UN MEDICAMENTO BENEFICO A UN ENTORNO
Japan	S63258409	PSEUDOEPHEDRINE ADMINISTRATIVE MEDICINE

Supplementary Protection Certificates for SUDAFED 24 HOUR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730
1110543	SPC/GB08/005	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB08/005 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT DESLORATADINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN COMBINATION WITH PSEUDOEPHEDRINE OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6322 DATED 21 JULY 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 JULY 2022.

Market Dynamics and Financial Trajectory for SUDAFED 24 HOUR

Last updated: July 29, 2025

Introduction

SUDAFED 24 HOUR, a prominent over-the-counter (OTC) decongestant, has maintained relevance within the cardiovascular and respiratory care sectors for decades. Its formulation, which possesses extended-release properties, caters to consumers seeking long-lasting relief from nasal congestion. As the market for OTC cold and allergy medications evolves, understanding the shifting dynamics and its projected financial trajectory is crucial for stakeholders. This analysis explores the drivers shaping SUDAFED 24 HOUR's current market landscape, assesses competitive pressures, regulatory influences, and forecasts future financial outcomes based on present trends.

Market Overview

The global OTC respiratory products market signifies substantial growth, driven by increasing prevalence of allergic rhinitis, sinusitis, and common cold, coupled with rising consumer preference for self-medication. The North American market, where SUDAFED 24 HOUR predominantly holds a significant share, is projected to sustain steady growth owing to aging populations and heightened health awareness.

Market Size and Growth Rates:
According to a recent report by MarketResearch.com, the OTC respiratory therapeutics market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of approximately 4.2% from 2023 to 2028. The demand for extended-release formulations, including SUDAFED 24 HOUR, is bolstered by consumer preference for convenience and longer-lasting symptom relief.

Key Market Drivers

Consumer Preference for Convenient and Extended-Relief Products

The shift towards long-acting formulations like SUDAFED 24 HOUR aligns with consumer demand for products providing sustained efficacy over multiple hours, reducing dosing frequency and enhancing compliance. This trend was underscored during the COVID-19 pandemic when consumers prioritized self-care and minimized healthcare visits.

Regulatory Environment and OTC Accessibility

Regulatory frameworks, especially in North America, support the sale of SUDAFED 24 HOUR OTC, facilitating widespread distribution through pharmacies and retail outlets. However, regulatory scrutiny regarding pseudoephedrine-based drugs persists due to misuse concerns, impacting supply chains and sales volumes.

Prevalence of Allergic Rhinitis and Respiratory Conditions

The global increase in allergic rhinitis prevalence, affecting approximately 10-30% of the population in developed nations [1], sustains demand for OTC nasal decongestants. Population aging further exacerbates symptoms, enhancing market potential.

Competitive Landscape

SUDAFED 24 HOUR faces competition from various brands offering similar benefits, such as Claritin-D, Allegra-D, and store brands. Its unique extended-release formulation retains value, but price competition and formulation innovation continue to pressure market share.

Regulatory and Legal Factors

The pseudoephedrine content within SUDAFED 24 HOUR subjects it to strict regulation, mainly to prevent methamphetamine synthesis derivation. In regions like the U.S., 21 CFR Part 1306 mandates sales logging and purchase limits, potentially constraining retail volumes. Ongoing regulatory developments could influence product formulation and sales strategies, particularly with initiatives favoring non-synthetic alternatives.

Supply Chain and Manufacturing Considerations

Disruptions from global supply chain challenges, including raw material shortages and logistical bottlenecks, impact manufacturing costs and distribution efficiency. Companies that optimize supply chains and diversify sourcing may sustain favorable financial outcomes amid such volatility.

Financial Trajectory and Market Potential

Revenue Projections

Given the steady growth in OTC respiratory products and the enduring consumer demand for sustained relief, SUDAFED 24 HOUR’s sales are expected to remain stable or modestly increase over the next five years. The product's extended-release advantage secures consumer loyalty, enabling premium pricing strategies.

Pricing and Margins

Price sensitivity in OTC markets poses challenges; however, differentiation through formulation efficacy allows for favorable gross margins. As genericization progresses, market prices could decline, compressing margins unless innovations or brand loyalty mitigate pressures.

Market Penetration Strategies

Pharmaceutical companies, leveraging digital marketing, patient education, and strategic retail partnerships, aim to enhance market penetration. Additionally, expanding into emerging markets with increasing respiratory disease burdens could expand SUDAFED 24 HOUR’s global footprint.

Emerging Trends and Innovation

Intraregional regulatory push for non-synthetic decongestants and advancements in formulation technology might prompt reformulation efforts. Companies investing in novel drug delivery systems or combination products could influence future financial trajectories.

Competitive Outlook

Despite robust market fundamentals, intense competition and regulatory risk necessitate proactive strategies. Innovation and marketing differentiation, alongside collaborations with healthcare providers, can fortify market positioning. The product’s resilience, however, depends on maintaining compliance and adapting swiftly to regulatory shifts.

Risks and Challenges

• Regulatory Constraints: Heightened controls over pseudoephedrine-containing products may restrict sales channels.
• Market Saturation: Increased competition from generics and alternative therapies can erode market share.
• Consumer Preferences: Shift towards natural or non-pharmaceutical alternatives may reduce demand.
• Supply Chain Vulnerabilities: Disruptions could inflate costs and hinder availability.

Conclusion

SUDAFED 24 HOUR stands as a resilient player within the OTC decongestant segment, supported by consumer preference for long-lasting relief and a considerable market presence. While regulatory hurdles and intense competition pose challenges, strategic innovation, supply chain optimization, and market expansion efforts foster a positive financial outlook. As respiratory health concerns escalate globally and OTC healthcare frameworks evolve, SUDAFED 24 HOUR’s market dynamics suggest stable growth with potential for incremental revenue increases, especially through leveraging brand loyalty and emerging markets.

Key Takeaways

• The global OTC respiratory market is projected to grow at 4.2% CAGR through 2028, benefitting SUDAFED 24 HOUR.
• Consumer demand for convenient, extended-release therapies sustains product relevance amid evolving health trends.
• Regulatory constraints on pseudoephedrine ingredients influence supply and sales strategies; compliance remains critical.
• Supply chain resilience and innovation in formulation or delivery systems are key to maintaining competitive advantage.
• Expanding into emerging markets and reinforcing brand loyalty can unlock additional revenue streams.

FAQs

1. How does regulatory oversight impact SUDAFED 24 HOUR sales?
   Regulatory controls on pseudoephedrine, including purchase logs and volume restrictions, limit retail sales and necessitate compliance efforts, influencing overall revenue.

2. What competitive advantages does SUDAFED 24 HOUR hold?
   Its extended-release formulation offers longer-lasting symptom relief, appealing to consumers seeking convenience and sustained efficacy.

3. What are the main risks facing SUDAFED 24 HOUR’s market share?
   Increased competition from generic brands, regulatory tightening, and consumer shifts towards natural alternatives threaten market dominance.

4. Can emerging markets contribute to SUDAFED 24 HOUR’s growth?
   Yes; countries experiencing rising respiratory conditions and expanding OTC healthcare infrastructure present significant growth opportunities.

5. What innovations could enhance SUDAFED 24 HOUR’s financial trajectory?
   Reformulation with non-synthetic decongestants, novel delivery systems, and strategic branding are potential avenues for future growth.

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References

[1] Bousquet, J., et al. (2008). The European Community Respiratory Health Survey: Prevalence and risk factors for allergic rhinitis. Allergy, 63(4), 383–387.