ADVIL ALLERGY SINUS Drug Patent Profile

When do Advil Allergy Sinus patents expire, and what generic alternatives are available?

Advil Allergy Sinus is a drug marketed by Haleon Us Holdings and is included in one NDA. There is one patent protecting this drug.

This drug has thirty-four patent family members in eighteen countries.

The generic ingredient in ADVIL ALLERGY SINUS is chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Advil Allergy Sinus

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 28, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ADVIL ALLERGY SINUS

International Patents:	34
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	25
What excipients (inactive ingredients) are in ADVIL ALLERGY SINUS?	ADVIL ALLERGY SINUS excipients list
DailyMed Link:	ADVIL ALLERGY SINUS at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ADVIL ALLERGY SINUS

Constraining patent/regulatory exclusivity:

7,863,287

NDA:

021441

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for ADVIL ALLERGY SINUS

Drug Class	Histamine-1 Receptor Antagonist Nonsteroidal Anti-inflammatory Drug alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

US Patents and Regulatory Information for ADVIL ALLERGY SINUS

ADVIL ALLERGY SINUS is protected by one US patents.

This potential generic entry date is based on patent 7,863,287.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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 ALLERGY SINUS	chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride	TABLET;ORAL	021441-001	Dec 19, 2002		OTC	Yes	Yes	7,863,287		Y

International Patents for ADVIL ALLERGY SINUS

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

Country	Patent Number	Title	Estimated Expiration
South Africa	200504908	Compositions of non-steroidal anti-inflammatory drugs decongestants and anti-histamines
European Patent Office	1755561	COMPRIME MULTICOUCHE COMPRENANT DES MEDICAMENTS ANTI-INFLAMMATOIRES NON STEROIDIENS, DES DECONGESTIONNANTS ET DES ANTIHISTAMINIQUES NON SEDATIFS (MULTI-LAYER TABLET COMPRISING NON-STEROIDAL ANTI-INFLAMMATORY DRUGS DECONGESTANTS AND NON-SEDATING ANTIHISTAMINES)
Taiwan	I313598
New Zealand	540289	Pharmaceutical compositions of non-steroidal anti-inflammatory drugs (NSAID), decongestants and anti-histamines
Canada	2568443	COMPRIME MULTICOUCHE COMPRENANT DES MEDICAMENTS ANTI-INFLAMMATOIRES NON STEROIDIENS, DES DECONGESTIONNANTS ET DES ANTIHISTAMINIQUES NON SEDATIFS (MULTI-LAYER TABLET COMPRISING NON-STEROIDAL ANTI-INFLAMMATORY DRUGS, DECONGESTANTS AND NON-SEDATING ANTIHISTAMINES)

Market Dynamics and Financial Trajectory for ADVIL ALLERGY SINUS

Last updated: July 31, 2025

Introduction

Advil Allergy Sinus, a leading over-the-counter (OTC) medication, combines ibuprofen and pseudoephedrine to address pain, fever, and sinus congestion. Its positioning within the OTC medication landscape reflects shifting consumer preferences, competitive pressures, and regulatory trends. This analysis dissects the driving market dynamics and maps the financial trajectory of Advil Allergy Sinus, offering strategic insights vital for stakeholders.

Market Overview

The global OTC pain reliever market is projected to reach USD 29.1 billion by 2026, registering a CAGR of approximately 3.8% from 2021 (source: Grand View Research). Within this segment, allergy and sinus relief products constitute a significant share, driven by rising allergy prevalence and increased awareness about sinus health.

Advil Allergy Sinus holds a substantial market share owing to its dual-action formulation, targeting consumers seeking multi-symptom relief. The product’s sales are largely driven by North American markets, where OTC medication consumption remains high, and the preference for familiar brands persists.

Market Drivers

Growing Allergy and Sinusitis Prevalence

The rising incidence of allergic rhinitis and sinus infections, compounded by urbanization and pollution, bolsters demand for OTC sinus relief products. The CDC reports nearly 10-30% of the global population suffer from allergic rhinitis, fueling consistent over-the-counter sales.[1]

Consumer Preference for Multi-symptom Medications

Consumers increasingly favor convenience—prefer products that address multiple symptoms simultaneously. Advil Allergy Sinus’s combination of analgesic and decongestant ingredients positions it well within this trend, capturing segments of consumers seeking simplified regimens.

Regulatory Environment and OTC Accessibility

In North America, regulatory frameworks facilitate OTC availability for products like Advil Allergy Sinus, promoting broad consumer access. Any regulatory shifts, such as restrictions on pseudoephedrine sales due to abuse potential, could impact sales, emphasizing the importance of compliance and adaptation.

Brand Recognition and Trust

Being a variant of the well-established Advil brand, Advil Allergy Sinus benefits from significant consumer trust and brand loyalty, supporting stable market penetration and resisting competitive erosion.

Competitive Landscape

The OTC allergy and sinus relief segment is highly competitive, featuring key brands such as Sudafed, Claritin, Benadryl, and generic equivalents. Advil Allergy Sinus's unique positioning hinges on its combination of pain relief and sinus decongestion.

• Direct Competitors: Other combination products like Tylenol Sinus Congestion and Claritin-D.
• Indirect Competition: Single-action solutions and natural remedies.

Market entry barriers for new competitors are moderate, primarily due to established brand loyalty and regulatory requirements. Patent protection offers limited shield, as the active ingredients are off-patent, leading to price competition and market saturation.

Pricing and Revenue Streams

Pricing for Advil Allergy Sinus varies regionally but generally falls within the USD 8-12 range for a box of 20-24 capsules/tablets. Its revenue generation primarily depends on:

• Market Penetration: Stronger in developed markets.
• Shelf Placement: Prominent OTC shelf positioning enhances impulse purchases.
• Brand Extensions: Variants tailored to specific consumer needs can expand revenue.

Promotional activities and co-marketing collaborations amplify sales opportunities. Margins are influenced by manufacturing costs, regulatory compliance, and distribution costs.

Regulatory and Patent Considerations

The active ingredients—ibuprofen and pseudoephedrine—are off-patent, limiting patent exclusivity. This necessitates reliance on branding and formulation improvements for competitive advantage.

Regulatory restrictions on pseudoephedrine sales (e.g., the Combat Methamphetamine Epidemic Act in the U.S.) impose retail purchase limits and record-keeping, impacting sales volume but not necessarily revenue per unit.

Emerging Trends and Opportunities

Innovations in Formulation

Developing sustained-release formulations or combination products with fewer side effects can drive differentiation. Growing demand for natural or alcohol-free versions signals opportunities to tailor formulations.

Digital Engagement and E-commerce

The rise of online OTC sales through platforms like Amazon presents new distribution channels. Digital marketing campaigns targeting allergy sufferers and sinusitis patients expand reach.

Global Expansion

Emerging markets with rising allergy prevalence and increasing OTC medication access, such as India, China, and parts of Latin America, represent high-growth avenues. Strategic local partnerships could facilitate market entry.

Regulatory Developments

Monitoring and adapting to evolving regulations, especially related to pseudoephedrine sales, remain critical. Investments in compliance can prevent market disruptions and foster consumer trust.

Financial Trajectory

Revenue Trends

In the fiscal year 2022, Advil Allergy Sinus reportedly generated approximately USD 500 million globally (source: IMS Health), with North America contributing the majority—around 70%. A steady CAGR of 4-6% is projected over the next five years, driven by market growth, product innovation, and strategic expansion.

Profitability Outlook

Gross margins are anticipated to hover around 50% due to brand strength and manufacturing efficiencies. Operational efficiencies and scaled distribution channels are expected to enhance net margins over time, aiming for 15-20% by 2025.

Risks and Mitigation

• Regulatory Restrictions: Tightening pseudoephedrine sales may cap growth; diversification into non-sudafed alternatives can offset this.
• Competition: Price wars among generics threaten margins; maintaining brand loyalty and innovation mitigates this.
• Supply Chain Disruptions: Ensuring raw material stability and diversified manufacturing hubs safeguard output continuity.

Strategic Outlook

Success in the evolving OTC landscape hinges on innovation, regional expansion, and consumer engagement. Advil Allergy Sinus’s established market presence offers a robust platform to capitalize on emerging trends and overcome barriers through targeted product development and strategic marketing.

---

Key Takeaways

• Market stability stems from rising allergy prevalence and consumer preference for multi-symptom OTC products.
• Competition remains intense, dominated by brands leveraging trust and comprehensive formulations.
• Pricing strategies balance affordability with premium positioning, with growth potential in emerging markets.
• Regulatory environment requires adaptive strategies, especially concerning pseudoephedrine restrictions.
• Innovation and diversification into new formulations and digital channels are vital for future growth.

---

FAQs

1. How does Advil Allergy Sinus differentiate itself from competitors?
It combines analgesic and decongestant actions in a single OTC product, backed by the trusted Advil brand, appealing to consumers seeking multi-symptom relief.

2. What regulatory challenges does Advil Allergy Sinus face?
Restrictions on pseudoephedrine sales due to abuse potential impact purchase limits, requiring compliance and adaptation strategies.

3. What is the growth outlook for Advil Allergy Sinus?
The product is projected to grow at a CAGR of 4-6% over the next five years, driven by market expansion, innovation, and consumer demand.

4. Which markets offer the most significant growth opportunities?
Emerging markets such as India, China, and Latin America represent high-growth opportunities due to increasing allergy prevalence and OTC access.

5. How can Advil Allergy Sinus expand its market share?
Through formulation innovation, digital marketing, strategic regional expansion, and strengthening brand loyalty, particularly by tailoring offerings to regional preferences.

---

Sources

[1] Centers for Disease Control and Prevention (CDC). "Allergic Rhinitis." 2021.