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Last Updated: December 12, 2025

ADVIL CONGESTION RELIEF Drug Patent Profile


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Which patents cover Advil Congestion Relief, and what generic alternatives are available?

Advil Congestion Relief is a drug marketed by Haleon Us Holdings and is included in one NDA.

The generic ingredient in ADVIL CONGESTION RELIEF is ibuprofen; phenylephrine hydrochloride. There are sixty-four drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ibuprofen; phenylephrine hydrochloride profile page.

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Drug patent expirations by year for ADVIL CONGESTION RELIEF
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SponsorPhase
Pi Research and Development Center, BangladeshPHASE2
Sichuan Provincial People's HospitalNA
Beacon Pharmaceuticals PLCPHASE2

See all ADVIL CONGESTION RELIEF clinical trials

Pharmacology for ADVIL CONGESTION RELIEF

US Patents and Regulatory Information for ADVIL CONGESTION RELIEF

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 CONGESTION RELIEF ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022565-001 May 27, 2010 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Advil Congestion Relief

Last updated: August 1, 2025

Introduction

Advil Congestion Relief, a popular over-the-counter (OTC) medication designed to alleviate nasal congestion associated with colds and allergies, occupies a significant niche within the broader cold and allergy treatment market. As a branded combination of ibuprofen and nasal decongestants, it appeals to consumers seeking rapid symptom relief through a familiar, trusted format. This analysis explores the current market landscape, the drivers shaping demand, competitive positioning, regulatory considerations, and future financial trajectories for Advil Congestion Relief.

Market Landscape and Key Segments

The OTC cold and allergy relief market is highly competitive, estimated to reach approximately $12–15 billion globally by 2025, with North America accounting for a substantial share owing to consumer health awareness and purchasing power. Advil Congestion Relief competes within this segment against brands like Sudafed, Claritin, Mucinex, and store brands, which often leverage price competitiveness and distribution efficiency.

Core Consumer Demographics:
Primarily adults aged 18-65, with peak usage during winter months and allergy seasons. Increased consumer preference for multi-symptom formulations enhances the product’s attractiveness, especially among those seeking convenience.

Distribution Channels:
Pharmacies, mass merchandisers, online retailers, and convenience stores dominate purchasing channels. The rise of e-commerce, driven by COVID-19, has shifted purchasing patterns, increasing digital shelf presence.

Market Dynamics Catalysts

1. Consumer Behavior and Demand Fluctuations

Changing health consciousness fuels demand growth, especially amid ongoing respiratory illness concerns. The COVID-19 pandemic boosted OTC cold remedy sales, with consumers intensifying focus on symptom management at home. Seasonal variability further influences sales cycles, with peaks in colder months and allergy seasons.

2. Competitive Innovations and Product Differentiation

Market players continuously innovate through extended-release formulations, natural ingredients, and multi-symptom combinations. Advil’s distinct positioning leverages the trusted Advil brand reputation, yet faces challenges from generic equivalents and private labels that capitalize on cost savings.

3. Regulatory Environment

OTC drug regulation remains stable under agencies like the FDA (U.S.) and EMA (Europe), but recent initiatives focusing on drug safety and labeling transparency exert pressure on manufacturers to ensure compliance, potentially affecting formulation changes and reformulation costs.

4. Pricing Strategies and Consumer Price Sensitivity

While Advil Congestion Relief benefits from brand loyalty, price sensitivity among consumers prompts competitive pricing. Store brands and generics offer lower prices, threatening market share. However, premium branding coupled with effective marketing sustains value perception.

5. Distribution and Access

Expanding online sales channels and pharmacy formulary inclusion are critical. Partnerships with major online platforms and pharmacy chains bolster accessibility, affecting market penetration and revenue streams.

Financial Trajectory and Revenue Projections

Historical Performance and Current Market Share

Pfizer, the manufacturer of Advil Congestion Relief, maintains a dominant position in the NSAID segment and leverages Brand Equity to uphold at least a 15–20% share of the combined OTC cold relief market. With an estimated global sales volume in the tens of millions annually, revenue figures are projected to stabilize around $200–300 million annually in the U.S. alone, with potential for growth in international markets.

Growth Drivers

  • Seasonal Uptick: Consistent seasonal sales peaks during winter and allergy seasons provide predictable revenue boosts.
  • Product Line Extensions: Introducing formulations with natural decongestants or multi-symptom kits can diversify revenue sources.
  • Digital Marketing and E-commerce Expansion: Leveraging digital platforms is expected to sustain growth trajectories, capturing a broader demographic.

Potential Risks and Constraints

  • Generic Competition: The proliferation of equally effective generics constrains pricing and margins.
  • Regulatory Changes: Stricter safety regulations could necessitate reformulation or additional safety testing, increasing costs.
  • Consumer Trends: Growing preference for natural or homeopathic remedies may reduce reliance on traditional OTC drugs.

Forecasted Revenue Growth (2023–2028)

  • Conservative Scenario: CAGR of 2-3%, driven primarily by seasonal demand and incremental market share gains.
  • Optimistic Scenario: CAGR of 5-7%, facilitated by successful brand extensions, increased e-commerce penetration, and international expansion.

Profitability Outlook

Given the high-margin nature of OTC products, especially branded formulations, profit margins are generally robust. However, intensified price competition and increased marketing expenditures to safeguard market position may temper profitability growth.

Future Market Outlook

The future financial trajectory for Advil Congestion Relief hinges on several strategic initiatives:

  • Innovation and Differentiation: Incorporating natural ingredients or novel delivery mechanisms.
  • Global Expansion: Capitalizing on emerging markets with rising OTC consumption.
  • Digital Engagement: Utilizing data-driven marketing to target specific consumer segments.

Given these factors, a CAGR of approximately 3–5% over the next five years appears plausible, contingent upon market conditions and strategic execution.

Conclusion

Advil Congestion Relief’s market dynamics are shaped by consumer demand for effective, trusted OTC medications, competitive pressures, regulatory landscape, and evolving distribution channels. While facing stiff competition from generics and store brands, brand loyalty, innovation, and strategic marketing are critical to sustaining revenue growth. Financially, a stable but gradually expanding trajectory is anticipated, with opportunities for accelerated growth through product innovation, global outreach, and digital transformation.


Key Takeaways

  • The OTC cold and congestion relief market remains resilient with moderate growth prospects driven by seasonal demand and consumer preference for convenience.
  • Advil Congestion Relief leverages strong brand recognition, but faces intense generic competition that constrains margins.
  • Digital channels and global expansion present significant growth opportunities, especially in emerging markets.
  • Product innovation and strategic marketing are vital to differentiate and maintain market share amid evolving consumer trends.
  • Regulatory compliance remains a foundational element, with potential impacts on formulation and marketing strategies.

FAQs

Q1: What factors influence the consumer preference for Advil Congestion Relief over competitors?
Brand loyalty, proven efficacy, trusted safety profile, and the convenience of multi-symptom relief drive consumer preference. Strong marketing and widespread distribution also play significant roles.

Q2: How does the rise of natural and homeopathic remedies impact Advil Congestion Relief’s market?
Increased consumer interest in natural alternatives could shift demand away from traditional OTC formulations, necessitating product innovation away from synthetic ingredients to sustain market relevance.

Q3: What strategic moves can Pfizer pursue to enhance Advil Congestion Relief’s market share?
Developing new formulations, expanding digital marketing, investing in international markets, and forming strategic partnerships with online retailers are effective strategies.

Q4: How does regulatory scrutiny affect Advil Congestion Relief’s future?
Tighter safety regulations and labeling standards can increase development costs and influence product formulation, but adherence enhances consumer trust and brand integrity.

Q5: What is the outlook for Advil Congestion Relief’s international growth?
Emerging markets with increasing OTC medication consumption and expanding distribution channels present promising opportunities, with expected annual growth rates of approximately 4–6% in these regions.


References
[1] Market research reports on OTC cold remedies, 2023.
[2] Pfizer corporate disclosures, 2022.
[3] Regulatory frameworks overview, FDA and EMA guidelines, 2023.
[4] Consumer behavior analysis, Nielsen Reports, 2022.
[5] Industry trend observations, IQVIA, 2023.

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