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 J And J Consumer Inc 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	11
Patent Applications:	1,536
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 Center for Advancing Translational Science (NCATS)	Early Phase 1
Vanderbilt University	Early Phase 1

See all SUDAFED 24 HOUR clinical trials

Pharmacology for SUDAFED 24 HOUR

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

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
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992		OTC	Yes	Yes

Expired US Patents for SUDAFED 24 HOUR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992
J And J Consumer Inc	SUDAFED 24 HOUR	pseudoephedrine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	020021-002	Dec 15, 1992

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
Australia	568621
Denmark	162470
France	2541896	DISPOSITIF OSMOTIQUE PERMETTANT LA DISPONIBILITE IMMEDIATE D'UN MEDICAMENT

Supplementary Protection Certificates for SUDAFED 24 HOUR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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.
1110543	08C0004	France		PRODUCT NAME: DESLORATADINE; PSEUDOEPHEDRINE SULFATE; REGISTRATION NO/DATE: EU/1/07/399/001 20070730

SUDAFED 24 HOUR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of SUDAFED 24 Hour

Market Overview of Decongestants

The decongestant market, which includes products like SUDAFED 24 Hour, is experiencing significant growth driven by the increasing prevalence of colds, sinusitis, and allergies worldwide. The global decongestant market is projected to reach $24.67 billion by 2030, growing at a CAGR of 6.6% from 2023 to 2030[1].

Product Type and Active Ingredients

SUDAFED 24 Hour falls under the category of oral decongestants, which are available both over-the-counter (OTC) and by prescription. The most common active ingredients in these products are pseudoephedrine and phenylephrine. SUDAFED 24 Hour specifically contains pseudoephedrine, a sympathomimetic agent that helps relieve nasal congestion[5].

Regional Market Insights

North America currently dominates the decongestant market, largely due to high healthcare spending and growing awareness about cold relief products in the region. However, the Asia Pacific region is expected to emerge as the fastest-growing market, driven by an expanding patient population and rapid economic development in countries like India and China[1].

Market Segmentation

The decongestant market is segmented by product type, type of decongestant, mode of action, application, and distribution channel. SUDAFED 24 Hour, being an oral decongestant, fits into the tablets/capsules segment. These products are widely available through various distribution channels, including pharmacies, supermarkets, and online platforms[1].

Financial Performance and Trends

Between 2012 and 2021, there was a significant decline in the sales of pseudoephedrine-containing products, including those like SUDAFED 24 Hour. The sales of pseudoephedrine products decreased from 1.68 billion units in 2012 to 0.98 billion units in 2021, amounting to a total of $3.8 billion in pharmacy expenditures during this period. In contrast, phenylephrine product sales showed a positive trend, although not statistically significant for total sales[4].

Impact of Active Ingredients on Sales

Pseudoephedrine, the active ingredient in SUDAFED 24 Hour, has seen declining sales in recent years. This decline could be attributed to several factors, including regulatory changes, public perception, and the availability of alternative decongestants like phenylephrine. Phenylephrine, on the other hand, has seen an increase in stand-alone product sales, indicating a shift in consumer preference or prescribing practices[4].

Cardiovascular Effects and Consumer Concerns

Pseudoephedrine, while effective in relieving nasal congestion, has been associated with small but significant increases in systolic blood pressure (SBP) and heart rate (HR). Immediate-release formulations of pseudoephedrine have a greater effect on SBP and HR compared to sustained-release formulations. These cardiovascular effects might influence consumer choices and prescribing practices, potentially impacting the sales of SUDAFED 24 Hour[2].

Competitive Landscape

The decongestant market is highly competitive, with several major players including Johnson & Johnson, Pfizer Inc., GlaxoSmithKline plc, and Novartis AG. SUDAFED, a brand owned by Johnson & Johnson, is one of the well-known and trusted brands in the market. The competitive landscape is driven by innovation, marketing strategies, and regulatory compliance[1].

Distribution and Marketing Strategies

Effective distribution and marketing strategies play a crucial role in the success of decongestant products like SUDAFED 24 Hour. These products are widely available in pharmacies, supermarkets, and online platforms, making them easily accessible to consumers. Marketing campaigns often focus on highlighting the quick relief and long-lasting effects of these products, which can influence consumer purchasing decisions[1].

Regulatory Environment

The regulatory environment can significantly impact the sales and availability of decongestant products. Changes in regulations, such as those related to the sale of pseudoephedrine due to its potential for misuse in the production of methamphetamine, can affect the market dynamics. Compliance with these regulations is essential for maintaining market presence[4].

Consumer Preferences and Awareness

Consumer preferences and awareness about cold relief products are key drivers of the decongestant market. There is a growing trend towards self-medication and over-the-counter purchases, driven by increased awareness and the convenience of accessing these products. However, concerns about the side effects of pseudoephedrine may lead some consumers to opt for alternative decongestants[3].

Future Outlook

Despite the decline in pseudoephedrine sales, the overall decongestant market is expected to grow steadily. The increasing prevalence of respiratory conditions and the expanding patient population in emerging markets are likely to drive demand for decongestant products. Innovations in product formulations and delivery methods, such as sustained-release formulations, could also contribute to the market's growth[1].

Key Takeaways

• The global decongestant market is projected to reach $24.67 billion by 2030.
• North America dominates the market, but the Asia Pacific region is expected to grow rapidly.
• Pseudoephedrine-containing products, like SUDAFED 24 Hour, have seen declining sales due to various factors.
• Phenylephrine products are gaining traction, showing a positive sales trend.
• Cardiovascular effects of pseudoephedrine may influence consumer and prescribing choices.
• Effective distribution and marketing strategies are crucial for market success.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of the global decongestant market by 2030? A: The global decongestant market is projected to reach $24.67 billion by 2030[1].

Q: Which region currently dominates the decongestant market? A: North America currently dominates the decongestant market due to high healthcare spending and growing awareness about cold relief products[1].

Q: What are the common active ingredients in oral decongestants like SUDAFED 24 Hour? A: The most common active ingredients are pseudoephedrine and phenylephrine[1].

Q: Why have pseudoephedrine sales been declining? A: Pseudoephedrine sales have been declining due to factors such as regulatory changes, public perception, and the availability of alternative decongestants like phenylephrine[4].

Q: What are the cardiovascular effects of pseudoephedrine? A: Pseudoephedrine causes a small but significant increase in systolic blood pressure (SBP) and heart rate (HR), with immediate-release formulations having a greater effect[2].

Cited Sources:

1. Coherent Market Insights - Decongestant Market - Share, Size and Industry Analysis
2. JAMA Network - Effect of Oral Pseudoephedrine on Blood Pressure and Heart Rate
3. IndustryARC - Decongestants Market Size Report, 2022-2027
4. JAMA Network - Trends in Phenylephrine and Pseudoephedrine Sales in the US
5. SUDAFED - SUDAFED® Sinus Congestion 24 Hour