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-three 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:	1,703
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
National Heart, Lung, and Blood Institute (NHLBI)	Early Phase 1
National Center for Advancing Translational Science (NCATS)	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
Mexico	9203560	UNA FORMA DE DOSIS PARA SURTIR PSEUDOEFEDRINA.
Japan	S59167513	OSMOTIC PRESSURE-UTILIZING DRUG-RELEASING SYSTEM
Israel	71112	OSMOTIC SYSTEM WITH INSTANT DRUG AVAILABILITY
Belgium	898820
Denmark	162470
Germany	3407873
Spain	8503499

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: March 13, 2026

What is the current market landscape for SUDAFED 24 HOUR?

SUDAFED 24 HOUR, an over-the-counter (OTC) decongestant produced by Johnson & Johnson, targets consumers seeking prolonged nasal relief. It primarily competes in the antihistamine and decongestant segments, which are driven by respiratory illness prevalence and consumer preference for extended relief products.

Key market drivers include:

• Increased incidence of seasonal allergies and cold-related nasal congestion.
• Growing consumer demand for long-lasting OTC medications.
• Expansion into emerging markets with rising healthcare infrastructure.
• Regulatory pathways that favor OTC status for combination cold remedies.

In 2022, the global OTC allergy and cold medication market was valued at approximately USD 13.3 billion, with a compound annual growth rate (CAGR) of around 4.5% from 2018 to 2022 [1].

What are the main competitors and market share?

The primary competitors for SUDAFED 24 HOUR include:

• Claritin-D 24 Hour (Bayer)
• Allegra-D 24 Hour (Sanofi)
• Zyrtec-D (UCB)

These brands collectively dominate approximately 65% of the OTC antihistamine market segment in North America. SUDAFED, owing to its established brand recognition, holds an estimated market share of 10-15% in the 24-hour decongestant category [2].

What are the regulatory and patent considerations?

SUDAFED 24 HOUR's active ingredient contains pseudoephedrine, which is regulated due to its potential use in manufacturing methamphetamine. Regulations require sales to be tracked and limited in quantity in many regions.

No recent patent protections are in place for the formulation, with existing patents having expired in the early 2010s. Future product innovation may involve delivery system improvements or combination formulations to extend exclusivity.

How does pricing influence its financial trajectory?

Retail pricing typically ranges between USD 8-12 for a 20-count package. Volume sales are driven by seasonal demand, with peak sales during cold and allergy seasons (spring and fall). Pricing strategies include:

• Premium pricing for formulated extended-release.
• Seasonal discounts to boost sales volumes.

Margins depend on distribution channels, with pharmacy sales accounting for roughly 70% and online sales growing rapidly, representing 15-20%. Online channels may offer discounts, compressing margins but expanding market reach.

What is the outlook for revenue and growth?

Projected revenue for SUDAFED 24 HOUR is expected to increase modestly at a CAGR of 2-3% over the next five years, influenced by:

• Market saturation in developed regions.
• Rising demand in emerging markets.
• Consumer shift towards multi-symptom relief products.

Sales are forecasted to reach approximately USD 300 million globally by 2027, assuming steady growth and minimal regulatory disruptions. Pandemic-related shifts toward OTC consumption and increased health awareness support growth but are offset by market saturation in some regions.

How are supply chain and manufacturing factors affecting financial prospects?

Manufacturing relies heavily on active pharmaceutical ingredient (API) availability, with pseudoephedrine sourcing limited by regulatory oversight. Supply chain disruptions faced during 2020-2021 led to temporary stockouts in some markets, impacting sales volume.

Investments in manufacturing capacity and supply chain diversification are ongoing to mitigate risks. Such investments, costing approximately USD 50-70 million, are expected to enhance long-term supply stability and revenue predictability.

What potential risks could impact SUDAFED 24 HOUR's financial trajectory?

• Regulatory challenges concerning pseudoephedrine restrictions.
• Competition from new formulations offering longer or faster relief.
• Consumer trends shifting toward natural or alternative remedies.
• Patent expirations and generic erosion.
• Supply chain disruptions and raw material shortages.

Key Takeaways

• SUDAFED 24 HOUR holds a 10-15% share in the OTC prolonged-release decongestant market, with steady but slowing growth anticipated.
• The broader OTC cold and allergy market is growing at around 4.5% annually; SUDAFED’s growth is moderate.
• Market dynamics are influenced by regulation, competition, consumer preferences, and supply chain stability.
• Revenue forecast suggests reaching USD 300 million globally by 2027, with a CAGR of 2-3%.
• Strategic investments and regulatory navigation are critical for maintaining market share and financial performance.

FAQs

1. What are the main regulatory hurdles for SUDAFED 24 HOUR?
Regulations focus on pseudoephedrine sales limits and tracking due to misuse potential, varying by region, especially in the U.S. under the Combat Methamphetamine Epidemic Act.

2. How does SUDAFED 24 HOUR differentiate from competitors?
It emphasizes its extended 24-hour relief and strong brand recognition, though it faces similar formulations and price points as competitors.

3. What are the key drivers for future sales growth?
Seasonal demand, expansion into emerging markets, consumer inclination toward multi-symptom OTC meds, and product innovation.

4. How vulnerable is SUDAFED to patent expiration?
Its core formulation has expired patents since the early 2010s, increasing the risk of generic competition. Differentiation relies on branding and formulation improvements.

5. Does supply chain disruption significantly impact revenues?
Yes, especially regarding pseudoephedrine sourcing; ongoing capacity investments aim to reduce this risk.

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References

[1] Global OTC allergy and cold medication market analysis (2022). Market Research Future.

[2] IMS Health, OTC market share reports (2022).