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. Thirteen 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 STRIDES PHARMA 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
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

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
Australia	589554
Japan	H08157354	BASIC PHARMACEUTICAL SOLUTION FOR SOFT GEL FILLING,TWO-PIECECAPSULE SEALING OR TABLET MANUFACTURING
World Intellectual Property Organization (WIPO)	8808302
Australia	1687388
Germany	3585495
South Korea	940008030

Market Dynamics and Financial Trajectory for Advil Cold and Sinus

Last updated: February 11, 2026

Overview

Advil Cold and Sinus, a generic over-the-counter (OTC) medication, competes within the cold and flu relief segment. Its primary active ingredients are ibuprofen and pseudoephedrine, targeting pain, fever, and nasal congestion. Its market positioning relies on brand recognition, active ingredient efficacy, and consumer preferences for multi-symptom relief.

Market Size and Segmentation

The global OTC cold and flu remedy market reached approximately $11.2 billion in 2022, forecasted to grow at a compound annual growth rate (CAGR) of 4.2% through 2027 [1]. In the United States, the segment accounts for roughly 50% of the global market, with an estimated market value of $5.6 billion in 2022 [2].

Key Players and Competitive Landscape

Major competitors include Tylenol Cold (Johnson & Johnson), DayQuil (Procter & Gamble), and store-brand generics. Advil Cold and Sinus benefits from the Advil brand, which is associated with ibuprofen's pain relief efficacy. Store-brand competition has intensified due to pricing pressures and increased focus on consumer health consciousness.

Market Drivers

• Seasonal demand during fall and winter quarters.
• Growing consumer preference for multi-symptom OTC solutions.
• Increased awareness about cold and flu management.
• Expansion in emerging markets with rising healthcare awareness and OTC OTC OTC OTC OTC OTC OTC OTC volume.

Regulatory and Distribution Channels

The product relies on regulatory approvals as an OTC drug in multiple jurisdictions, including the FDA in the U.S. and EMA in Europe. Distribution channels include pharmacies, supermarkets, online platforms, and convenience stores, with online sales accounting for approximately 15% of OTC cold remedy sales in North America [3].

Pricing and Revenue

Pricing varies by region; in the U.S., a 20-count box retails from $7.99 to $11.99, depending on the retailer and formulation. Volume sales serve as a primary revenue driver, with profit margins influenced by manufacturing costs, branding, and promotional campaigns.

Financial Trajectory

• Revenue Trends: In North America, Advil Cold and Sinus sales are estimated at $300-350 million annually, with fluctuations tied to seasonal demand and competition.
• Margin Analysis: Gross margins for OTC formulations typically range between 50-65%. Advil's strong brand recognition enhances pricing power.
• Growth Prospects: Industry analysts project a 2-3% annual growth rate in North American OTC cold remedy markets, driven by population aging and product innovation.
• R&D and Regulatory Investment: Minimal R&D due to established formulations; most ongoing costs involve marketing, packaging, and regulatory compliance.

Recent Market Trends

• Shift toward combination products with added benefits such as allergy relief.
• Increased e-commerce sales, which grew by approximately 20% during the COVID-19 pandemic.
• Regulatory scrutiny concerning pseudoephedrine sales limitations, impacting supply chain logistics [4].

Forecasts

Over the next five years, Advil Cold and Sinus is projected to maintain steady revenue streams provided it adapts to market shifts, such as increased online sales and emerging markets. Overall, revenue growth remains constrained by high generic competition and pharmacy store dynamics.

Key Financial Risks

• Pricing pressures from store-brand equivalents.
• Regulatory restrictions on pseudoephedrine sales affecting inventory.
• Consumer shift toward natural and herbal remedies.
• Pandemic-related disruptions impacting seasonal demand patterns.

Conclusion

Advil Cold and Sinus's financial trajectory depends on its ability to sustain brand loyalty, adapt to evolving consumer preferences, and navigate regulatory changes. Its position within a mature OTC market limits explosive growth, yet stable demand during peak seasons underpins steady revenue.

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Key Takeaways

• The OTC cold and flu relief market is expanding modestly, with Advil Cold and Sinus capturing a significant share through brand recognition and multi-symptom relief.
• Revenue is predominantly seasonal, with stable margins supported by established formulation and marketing.
• Competition from generics and evolving regulatory environments pose ongoing risks.
• Growing online sales channels offer new revenue opportunities but require strategic adaptation.
• Market growth remains constrained by competitive and regulatory factors, emphasizing the importance of product differentiation and supply chain resilience.

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FAQs

1. What are the primary active ingredients in Advil Cold and Sinus?
Ibuprofen (for pain and fever) and pseudoephedrine (for nasal congestion).

2. How does Advil Cold and Sinus compare with competitors in market share?
It ranks among leading OTC cold remedies, though exact market share data is proprietary. It competes primarily on brand strength and formulation.

3. What regulatory challenges exist for Advil Cold and Sinus?
Restrictions on pseudoephedrine sales due to misuse concerns can limit availability and distribution logistics.

4. How has e-commerce affected Advil Cold and Sinus sales?
E-commerce sales grew approximately 20% during COVID-19, contributing to overall revenue, but require targeted marketing and logistics strategies.

5. What are the future growth prospects for this product?
Steady, driven by seasonal demand and new market penetration, but limited by generic competition and regulatory hurdles.

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References

[1] MarketWatch. "Over-the-Counter Cold and Flu Remedies Market Size & Trends." 2022.
[2] Statista. "Over-the-counter (OTC) medicine market in the United States." 2022.
[3] Nielsen. "OTC Cold and Flu Relief Sales Data." 2022.
[4] FDA. "Pseudoephedrine Sales Regulations." 2022.