ADVIL COLD AND SINUS Drug Patent Profile

Which patents cover Advil Cold And Sinus, and what generic alternatives are available?

Advil Cold And Sinus is a drug marketed by Haleon Us Holdings and is included in two NDAs.

The generic ingredient in ADVIL COLD AND SINUS is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Advil Cold And Sinus

A generic version of ADVIL COLD AND SINUS was approved as ibuprofen; pseudoephedrine hydrochloride by DR REDDYS LABS LTD on August 14^th, 2006.

Summary for ADVIL COLD AND SINUS

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	2
What excipients (inactive ingredients) are in ADVIL COLD AND SINUS?	ADVIL COLD AND SINUS excipients list
DailyMed Link:	ADVIL COLD AND SINUS at DailyMed

Pharmacology for ADVIL COLD AND SINUS

Drug Class	Nonsteroidal Anti-inflammatory Drug alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Cyclooxygenase Inhibitors

US Patents and Regulatory Information for ADVIL COLD AND SINUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002		OTC	Yes	Yes
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	019771-001	Sep 19, 1989		OTC	Yes	Yes

Expired US Patents for ADVIL COLD AND SINUS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	019771-001	Sep 19, 1989
Haleon Us Holdings	ADVIL COLD AND SINUS	ibuprofen; pseudoephedrine hydrochloride	CAPSULE;ORAL	021374-001	May 30, 2002

International Patents for ADVIL COLD AND SINUS

See the table below for patents covering ADVIL COLD AND SINUS around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	940008030
South Korea	940006270
Canada	1316823	PREPARATION DE CERTAINS MEDICAMENTS EN VUE DE FAVORISER LEUR ENCAPSULATION (FACILITATION OF CERTAIN DRUGS FOR CAPSULATION)
Japan	H08157355	AMPHOTERIC PHARMACEUTICAL SOLUTION FOR SOFT GEL FILLING, TWO-PIECE CAPSULE SEALING OR TABLET MANUFACTURING
Australia	2029195

ADVIL COLD AND SINUS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Advil Cold and Sinus

Market Overview

The cold and flu drugs market, within which Advil Cold and Sinus operates, is experiencing significant growth driven by several key factors. The global cold and flu drugs market was valued at USD 16.85 billion in 2024 and is projected to reach USD 29.39 billion by 2031, growing at a CAGR of 7.20% from 2024 to 2031[3].

Demand Drivers

Increasing Incidence of Influenza and Common Cold

The high prevalence of influenza and common cold cases globally is a major driver for the demand of cold and flu medications. According to the World Health Organization (WHO), annual influenza epidemics result in about 3 to 5 million cases of severe illness worldwide. In the United States alone, the Centers for Disease Control and Prevention (CDC) estimates that influenza has resulted in 9 million to 41 million illnesses annually between 2010 and 2020[3].

Growing Aging Population

The elderly population is more susceptible to cold and flu infections due to weakened immune systems. The global population aged 65 and above is expected to reach 1.5 billion by 2050, nearly doubling from 727 million in 2020, which will increase the demand for cold and flu medications[3].

Rising Healthcare Expenditure

Increased healthcare expenditure, particularly in regions like North America and the Asia Pacific, is another significant factor. The growing middle class and rising disposable incomes in these regions enable more people to invest in healthcare products, including over-the-counter (OTC) medications like Advil Cold and Sinus[3].

Product Profile: Advil Cold and Sinus

Active Ingredients and Mechanism

Advil Cold and Sinus combines ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), with pseudoephedrine, a nasal decongestant. Ibuprofen relieves pain and reduces fever by inhibiting cyclooxygenase enzymes, while pseudoephedrine acts on adrenergic receptors to reduce nasal congestion[1].

Approved Conditions

This medication is approved for the treatment of common cold symptoms, including nasal congestion and sinus pressure, headache and body aches associated with the common cold or flu, and minor pains due to allergic reactions[1].

Market Position and Competition

Market Share and Sales

Advil Cold and Sinus, with its dual-action formula, holds a significant position in the market. While exact market share figures are not provided, it is known that combination products like Advil Cold and Sinus are more effective and thus more popular than single-ingredient options[1].

Pricing and Cost

The price of Advil Cold and Sinus is approximately $17 for 20 tablets, which works out to about $3.40 per day considering a typical daily dosage. This is slightly higher than Sudafed, which costs around $2 per day for a maximum recommended dose[1].

Financial Trajectory

Revenue Growth

The cold and flu drugs market, which includes Advil Cold and Sinus, is expected to grow significantly. The market's CAGR of 7.20% from 2024 to 2031 indicates a robust financial trajectory for products in this category[3].

Parent Company Performance

GlaxoSmithKline (GSK), the parent company of Advil Cold and Sinus, reported strong financial performance in recent years. In 2021, GSK's Consumer Healthcare segment saw a turnover increase of 6% at actual exchange rates (AER) and 10% at constant exchange rates (CER), driven by strong growth in respiratory health products, including those for cold and flu[2].

Regional Performance

North America

North America is a dominant region for the cold and flu drugs market, including Advil Cold and Sinus. The high incidence of respiratory illnesses and an advanced healthcare infrastructure contribute to the robust demand for OTC medications in this region[3].

Asia Pacific

The Asia Pacific region is also experiencing rapid growth, driven by increasing healthcare access, rising disposable incomes, and a growing population. This region is expected to be a significant market for Advil Cold and Sinus in the coming years[3].

Challenges and Opportunities

Side Effects and Interactions

While Advil Cold and Sinus offers comprehensive relief from cold and sinus symptoms, it can also cause side effects such as stomach upset, headache, and increased blood pressure. Managing these side effects and potential interactions with other medications is crucial for maintaining market trust[1].

Regulatory and Competitive Landscape

The market is highly competitive, with various OTC and prescription medications available. Regulatory approvals and compliance are essential for maintaining market presence. The approval of Advil Cold and Sinus by regulatory bodies like the FDA underscores its safety and efficacy[1].

Key Takeaways

• Growing Demand: The cold and flu drugs market is driven by increasing incidence of influenza and common cold, a growing aging population, and rising healthcare expenditure.
• Product Efficacy: Advil Cold and Sinus offers dual-action relief from pain, fever, and nasal congestion, making it a preferred choice for comprehensive symptom management.
• Financial Growth: The market is expected to grow at a CAGR of 7.20% from 2024 to 2031, indicating a strong financial trajectory for Advil Cold and Sinus.
• Regional Dominance: North America and the Asia Pacific are key regions driving the demand for Advil Cold and Sinus.
• Regulatory Compliance: Maintaining regulatory approvals and managing side effects are crucial for market success.

FAQs

Q: What are the active ingredients in Advil Cold and Sinus? A: Advil Cold and Sinus contains ibuprofen and pseudoephedrine as its active ingredients[1].

Q: What conditions is Advil Cold and Sinus approved to treat? A: It is approved for treating common cold symptoms, including nasal congestion and sinus pressure, headache and body aches associated with the common cold or flu, and minor pains due to allergic reactions[1].

Q: How does Advil Cold and Sinus compare to Sudafed in terms of cost? A: Advil Cold and Sinus is slightly more expensive than Sudafed, with a daily cost of about $3.40 compared to Sudafed's $2 per day[1].

Q: What are the common side effects of Advil Cold and Sinus? A: Common side effects include stomach upset, headache, dizziness, nausea, and increased blood pressure[1].

Q: Which regions are expected to drive the demand for Advil Cold and Sinus in the future? A: North America and the Asia Pacific are expected to be the key regions driving the demand for Advil Cold and Sinus due to their advanced healthcare infrastructure and growing populations[3].

Cited Sources

1. Sudafed vs Advil Cold And Sinus | Power - Clinical Trials
2. Full year and fourth quarter 2021 - GSK
3. Cold And Flu Drugs Market Size, Share, Trends & Forecast
4. Details for: ADVIL COLD AND SINUS NIGHTTIME
5. Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report