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

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.

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			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
Canada	2508611	COMPOSITIONS DE MEDICAMENTS ANTI-INFLAMMATOIRES NON-STEROIDAUX, DECONGESTIONNANTS ET ANTIHISTAMINIQUES (COMPOSITIONS OF NON-STEROIDAL ANTI-INFLAMMATORY DRUGS DECONGESTANTS AND ANTI-HISTAMINES)
Colombia	5640087	COMPOSICIONES DE FARMACOS ANTI-INFLAMATORIOS NO ESTEROIDEOS DESCONGESTIONANTES Y ANTI-HISTAMINICOS
Peru	20040973	COMPOSICIONES DE ANTI-HISTAMINICOS, DESCONGESTIVOS Y DROGAS ANTI-INFLAMATORIAS NO ESTEROIDALES

Advil Allergy Sinus: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Advil Allergy Sinus is an over-the-counter (OTC) medication primarily used for the temporary relief of nasal congestion, sinus pressure, headache, and runny nose associated with allergies and the common cold. Its active ingredients are ibuprofen (a nonsteroidal anti-inflammatory drug, NSAID) and pseudoephedrine hydrochloride (a decongestant).

What is the Market Landscape for OTC Allergy and Sinus Medications?

The global market for allergy and sinus medications is substantial, driven by the high prevalence of allergic rhinitis and the common cold. This segment includes prescription and OTC products. Advil Allergy Sinus operates within the OTC segment, which benefits from accessibility and consumer self-treatment.

• Market Size: The global OTC allergy and cold market was valued at approximately $30 billion in 2022. Projections indicate a compound annual growth rate (CAGR) of 3-5% through 2030, reaching an estimated $45-50 billion. (Source: Market research reports, e.g., Grand View Research, Statista).
• Key Drivers:
  • Increasing incidence of allergies and respiratory ailments.
  • Growing consumer awareness and preference for self-medication.
  • Seasonal demand fluctuations.
  • New product development and formulation advancements.
• Competitive Environment: The OTC allergy and sinus market is highly competitive, with numerous established brands and private label offerings. Key competitors to Advil Allergy Sinus include products containing ingredients like loratadine, cetirizine, fexofenadine (antihistamines), and phenylephrine, pseudoephedrine (decongestants). Examples include Claritin, Zyrtec, Allegra, and various store-brand equivalents.
• Regulatory Considerations: OTC drug regulation by bodies like the U.S. Food and Drug Administration (FDA) ensures product safety and efficacy. The availability of pseudoephedrine is subject to state and federal regulations due to its potential diversion for illicit drug manufacturing, often requiring behind-the-counter placement and purchase limitations.

What are the Key Active Ingredients and Their Mechanism of Action?

Advil Allergy Sinus contains two primary active ingredients:

• Ibuprofen:
  • Class: Nonsteroidal Anti-inflammatory Drug (NSAID).
  • Mechanism: Inhibits cyclooxygenase (COX) enzymes (COX-1 and COX-2), thereby reducing the synthesis of prostaglandins. Prostaglandins are involved in mediating pain, inflammation, and fever.
  • Therapeutic Effect: Provides pain relief for headaches and sinus pain, and reduces inflammation associated with sinus congestion.
• Pseudoephedrine Hydrochloride:
  • Class: Sympathomimetic amine, specifically a decongestant.
  • Mechanism: Acts as an alpha-adrenergic agonist, causing vasoconstriction of the blood vessels in the nasal mucosa. This reduces swelling and congestion, facilitating easier breathing.
  • Therapeutic Effect: Relieves nasal congestion and sinus pressure.

What is the Patent Landscape for Advil Allergy Sinus?

As Advil Allergy Sinus is an established OTC product, its core formulations and active ingredients are largely off-patent. The primary intellectual property surrounding such products typically lies in:

• Formulation Patents: These patents may cover specific combinations of active ingredients, novel delivery systems (e.g., extended-release formulations), or specific excipients that enhance stability, efficacy, or patient compliance.
• Manufacturing Process Patents: Proprietary methods for synthesizing or combining the active ingredients can also be patented.
• Method of Use Patents: While less common for widely established OTC indications, new therapeutic uses discovered for existing drug combinations could be patentable.

Given the product's long market presence, it is unlikely that fundamental patents covering the combination of ibuprofen and pseudoephedrine for allergy and sinus relief remain in force. However, specific formulation enhancements or new indications might be protected.

• Patent Expirations: The patents for the active ingredients ibuprofen and pseudoephedrine expired decades ago. Patents for specific combination products and formulations will have their own distinct expiration dates, many of which have already passed for older versions.
• Generic Competition: The absence of strong, current patent protection for the core formulation allows for generic manufacturers to produce and market similar products, contributing to price competition.

What is the Commercial Performance and Financial Trajectory of Advil Allergy Sinus?

Advil Allergy Sinus, as part of the broader Advil brand and the broader Haleon (formerly GSK Consumer Healthcare) portfolio, contributes to the company's Over-the-Counter (OTC) segment. Specific financial data for individual product lines like Advil Allergy Sinus is not publicly disclosed, but its performance can be inferred from category trends and parent company reporting.

• Brand Strength: Advil is a well-established and trusted brand in the pain relief and cold/flu categories. This brand equity provides a significant advantage.
• Sales Channels: Distributed through major retail pharmacies (e.g., CVS, Walgreens, Rite Aid), mass merchandisers (e.g., Walmart, Target), supermarkets, and online retailers.
• Pricing Strategy: As an OTC product, pricing is influenced by competitor pricing, perceived brand value, and promotional activities. The presence of generics generally exerts downward pressure on prices for similar formulations.
• Haleon's OTC Segment Performance: Haleon’s Consumer Health segment (which includes Advil) generally exhibits stable to moderate growth, driven by demand for trusted brands in essential health categories. The allergy and sinus sub-segment typically sees seasonal peaks.
• Financial Outlook: The financial trajectory is expected to follow the overall growth of the OTC allergy and sinus market. Growth will be driven by market expansion, brand loyalty, and potentially product line extensions or new formulations that offer improved efficacy or convenience. Challenges include intense competition, pricing pressures from generics, and evolving consumer preferences for natural or alternative remedies.

What are the Key Challenges and Opportunities?

Challenges:

• Generic Competition: A significant portion of the market is served by lower-cost generic alternatives that offer similar active ingredients.
• Regulatory Scrutiny (Pseudoephedrine): Restrictions on the sale of pseudoephedrine in many jurisdictions (e.g., behind-the-counter requirements, purchase limits) can impact accessibility and consumer convenience. This has led some manufacturers to shift towards phenylephrine as a decongestant, although its efficacy has been debated.
• Evolving Consumer Preferences: Growing interest in natural remedies and alternative treatments for allergies and colds presents a challenge to traditional pharmaceutical products.
• Seasonal Variability: Sales are heavily influenced by seasonal patterns of allergies and cold/flu outbreaks, leading to predictable sales cycles.

Opportunities:

• Product Innovation: Development of improved formulations (e.g., faster-acting, longer-lasting, combination products with additional benefits like cough relief) can differentiate the product.
• Brand Extension: Leveraging the Advil brand for new product introductions within the allergy and sinus category.
• Geographic Expansion: Targeting emerging markets where OTC healthcare access is growing.
• Digital Engagement: Utilizing online channels for direct-to-consumer sales, educational content, and targeted marketing campaigns.
• Combination Therapies: Exploring the efficacy of ibuprofen and pseudoephedrine in combination with other active ingredients for broader symptom relief.

Key Takeaways

• Advil Allergy Sinus competes in a large, mature OTC market driven by seasonal demand and a high prevalence of allergy and cold symptoms.
• The product's core active ingredients, ibuprofen and pseudoephedrine hydrochloride, are off-patent, leading to significant generic competition.
• Intellectual property related to Advil Allergy Sinus likely resides in specific formulation enhancements or manufacturing processes, rather than fundamental composition patents.
• Haleon, the manufacturer, benefits from strong Advil brand equity. Financial performance is tied to the overall growth of the OTC allergy and sinus market and Haleon's broader Consumer Health segment.
• Key challenges include intense generic competition and regulatory hurdles for pseudoephedrine. Opportunities lie in product innovation, brand extension, and enhanced digital engagement.

Frequently Asked Questions

1. What is the primary difference between Advil Allergy Sinus and Advil Cold & Sinus? Advil Allergy Sinus typically contains ibuprofen and pseudoephedrine hydrochloride. Advil Cold & Sinus also contains ibuprofen and pseudoephedrine hydrochloride, often with very similar or identical formulations, serving a comparable symptom profile. Minor differences might exist in specific excipients or marketed indications.

2. Are there patent protections for Advil Allergy Sinus that prevent generic competition? The fundamental patents for the active ingredients ibuprofen and pseudoephedrine hydrochloride have long expired. While specific formulations or manufacturing processes might have had patent protection, many of these are likely expired, allowing for generic equivalents.

3. How do sales of Advil Allergy Sinus fluctuate throughout the year? Sales typically peak during allergy seasons (spring and fall) and during the common cold and flu season (fall and winter).

4. What is the impact of regulations on pseudoephedrine availability on Advil Allergy Sinus sales? Regulations requiring pseudoephedrine to be sold from behind the pharmacy counter and imposing purchase limits can reduce impulse purchases and impact consumer convenience, potentially affecting sales volume. This has also driven some market shifts to products containing phenylephrine.

5. What are the main competitors to Advil Allergy Sinus in the OTC market? Major competitors include other multi-symptom allergy and sinus relief products containing similar active ingredients or alternative antihistamines and decongestants, such as Claritin-D, Zyrtec-D, Allegra-D, and various store-brand equivalents.

Citations

[1] Grand View Research. (2023). Allergy and Cold Market Size, Share & Trends Analysis Report by Product (Antihistamines, Decongestants, Antitussives, Expectorants), by Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online), by Region, and Segment Forecasts, 2023 - 2030.

[2] Statista. (n.d.). Over-the-counter (OTC) drugs market – United States. Retrieved from Statista.

[3] Haleon PLC. (2023). Annual Report and Financial Statements 2023.