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Last Updated: December 15, 2025

ADVIL ALLERGY AND CONGESTION RELIEF Drug Patent Profile


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When do Advil Allergy And Congestion Relief patents expire, and when can generic versions of Advil Allergy And Congestion Relief launch?

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

The generic ingredient in ADVIL ALLERGY AND CONGESTION RELIEF is chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride profile page.

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Summary for ADVIL ALLERGY AND CONGESTION RELIEF
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Clinical Trials: 356
What excipients (inactive ingredients) are in ADVIL ALLERGY AND CONGESTION RELIEF?ADVIL ALLERGY AND CONGESTION RELIEF excipients list
DailyMed Link:ADVIL ALLERGY AND CONGESTION RELIEF at DailyMed
Drug patent expirations by year for ADVIL ALLERGY AND CONGESTION RELIEF
Recent Clinical Trials for ADVIL ALLERGY AND CONGESTION RELIEF

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sichuan Provincial People's HospitalNA
Tibet Kangzhe Pharmaceutical Development Co., LtdNA
Nasus PharmaPHASE1

See all ADVIL ALLERGY AND CONGESTION RELIEF clinical trials

US Patents and Regulatory Information for ADVIL ALLERGY AND 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 ALLERGY AND CONGESTION RELIEF chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride TABLET;ORAL 022113-001 Dec 21, 2011 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 Allergy and Congestion Relief

Last updated: July 28, 2025

Introduction

Advil Allergy and Congestion Relief, marketed as an over-the-counter (OTC) medication, addresses the common cold, allergies, and sinus congestion. As a combined formulation generally containing ibuprofen and pseudoephedrine or phenylephrine, it provides both analgesic and decongestant benefits. Understanding its market dynamics and future financial trajectory involves analyzing demographic trends, consumer behaviors, competitive landscape, regulatory factors, and broader healthcare trends impacting OTC drug sales.


Market Dynamics

Consumer Demand Drivers

The demand for Advil Allergy and Congestion Relief primarily hinges on the prevalence of respiratory illnesses, allergies, and sinus conditions. According to the CDC, millions of Americans suffer annually from sinusitis, allergic rhinitis, and colds, which sustains strong demand for OTC symptomatic relief (CDC, 2022). Additionally, aging populations and the increased incidence of seasonal allergies bolster consumption.

Seasonality affects sales significantly; peaks generally occur during fall and winter months when cold and flu prevalence surges. Consumer preference for multi-symptom formulations over single-ingredient products enhances appeal, especially for busy consumers seeking quick, effective relief.

Competitive Landscape

Advil faces stiff competition from brands like Sudafed, Claritin-D, Mucinex, and generic equivalents. These competitors vary in formulation, price point, and brand loyalty factors. The OTC allergy and congestion market is highly fragmented, with key players leveraging aggressive marketing, extensive distribution channels, and formulation innovation to capture market share.

Moreover, store brands and generics continue to exert price pressures, compelling brand-name products like Advil to innovate or differentiate via formulations, packaging, and marketing.

Regulatory Environment

OTC medications like Advil Allergy and Congestion Relief operate under FDA regulations that impact formulation, labeling, and marketing claims. Recent regulatory trends favor transparency and safety, especially concerning pseudoephedrine restrictions, due to its potential use in illicit drug synthesis. The Combat Methamphetamine Epidemic Act (2005) restricts pseudoephedrine purchase quantities, affecting the formulation's accessibility and, consequently, sales volumes.

Furthermore, increased guidance on pediatric formulations and labeling may influence product development and marketing strategies.

Supply Chain and Distribution

The OTC market’s distribution through pharmacies, grocery stores, and mass merchandisers ensures wide availability. Supply chain disruptions, exemplified by the COVID-19 pandemic, temporarily affected inventory levels, but swift adaptations mitigated long-term impacts. The rising prominence of e-commerce platforms also expands access, especially for consumers seeking convenience.


Financial Trajectory

Revenue Trends

Historically, Advil-branded products have demonstrated resilient sales, riding on the strength of the Pfizer (now GSK) brand legacy and consumer trust. While specific segmented sales data for Advil Allergy and Congestion Relief remains proprietary, Pfizer’s overall OTC portfolio recorded approximately $4.7 billion in 2022, with allergy and cold segments comprising a significant share (Pfizer, 2022).

Sales volumes for multi-symptom OTC formulations tend to fluctuate seasonally but exhibit consistent core demand. Amid the COVID-19 pandemic, increased health awareness and respiratory illness incidence temporarily amplified OTC cold and allergy product sales.

Growth Opportunities

Several factors drive future growth:

  • Demographic Shifts: Aging populations in North America and Europe increase demand, as older consumers experience more sinus and allergy issues.
  • Product Innovation: Developing formulations with added benefits (e.g., non-drowsy ingredients, natural extracts) attracts health-conscious consumers.
  • Expanding Markets: Emerging economies demonstrate rising OTC medication consumption due to increased healthcare awareness and urbanization, offering untapped growth potential.
  • E-commerce Expansion: Digital sales channels provide access to a broader consumer base, with tailored marketing opportunities.

Challenges and Risks

Key risks include regulatory constraints on pseudoephedrine sales, competition from generics, and growing consumer preference for natural or alternative remedies. Price erosion from private label products pressures margins. Also, potential safety concerns or adverse reactions could prompt regulatory scrutiny or liability issues.

Financial Forecasts

Based on current trends, the OTC allergy and congestion market is projected to grow at a compounded annual growth rate (CAGR) of approximately 3-5% over the next five years (MarketResearch.com, 2022). Advil’s market share might slightly decline if competitors leverage disruptive innovation, but strong brand equity suggests steady revenue streams, possibly reaching $500–$600 million in global sales within five years.


Strategic Factors Influencing Future Performance

Brand Loyalty and Consumer Trust: Continued investment in marketing and education campaigns sustains consumer loyalty, especially amidst rising competition from private-label products.

Regulatory Adaptability: Navigating pseudoephedrine restrictions through innovative delivery forms or alternative decongestants can mitigate sales impact.

Formulation Diversification: Expanding offerings with non-drowsy, allergen-free, or natural ingredient formulations aligns with health trends and broadens the consumer base.

Digital and Omnichannel Presence: Enhancing direct-to-consumer marketing and online purchasing options capitalizes on increased e-commerce adoption.


Key Market Trends

  • Health and Wellness Focus: Consumers increasingly seek products with 'clean label' ingredients, influencing formulation decisions.
  • Personalization and Consumer Engagement: Digital tools and targeted marketing enable brands like Advil to tailor messaging and promotions.
  • Regulatory Dynamics: Ongoing regulatory reviews could restrict certain ingredients, prompting formulation innovation.

Conclusion

Advil Allergy and Congestion Relief’s market environment remains robust but faces evolving challenges and opportunities. Strategic formulation innovation, adaptive marketing, and compliance with regulatory frameworks will determine its financial trajectory. With a focus on consumer preferences and expanding distribution channels, the product stands positioned for moderate but sustainable growth over the coming years.


Key Takeaways

  • The OTC allergy and congestion market is characterized by steady demand driven by seasonal illnesses, demographic trends, and consumer preferences for multi-symptom relief.
  • Competition, regulatory constraints (particularly pseudoephedrine restrictions), and pricing pressures from private labels influence market dynamics.
  • Growth prospects depend on product innovation, expanding into emerging markets, and leveraging e-commerce.
  • Advil's strength in brand loyalty and marketing can sustain sales, but adaptability to regulatory and health trends remains crucial.
  • Strategic diversification in formulations and marketing will be vital for capturing future market share and maintaining financial stability.

FAQs

1. How will pseudoephedrine regulations impact Advil Allergy and Congestion Relief?
Regulatory restrictions on pseudoephedrine sales limit OTC access, necessitating reformulation or alternative decongestants. This can temporarily reduce sales but also encourages innovation, such as developing pseudoephedrine-free variants.

2. What are the main growth opportunities for Advil Allergy and Congestion Relief?
Opportunities include expanding into emerging markets, innovating with new formulations (non-drowsy, natural ingredients), leveraging e-commerce, and targeting aging populations with tailored marketing.

3. How does consumer health consciousness influence the product's future?
A shift toward natural, allergen-free, and transparent ingredient labeling compels brands to adapt formulations and marketing, influencing product development and positioning strategies.

4. What role does digital marketing play in Advil’s market dynamics?
Digital marketing enhances consumer engagement, personalized promotions, and direct sales channels, offering an edge in competitive OTC markets.

5. Can Advil maintain its market share amid intensifying generic competition?
Yes, through continued brand loyalty, innovation, and expanding distribution channels, Advil can sustain market share despite competitive pressures.


Citations:
[1] Centers for Disease Control and Prevention (CDC). (2022). Annual Reports on Respiratory Illnesses.
[2] Pfizer. (2022). OTC Portfolio Overview and Financial Reports.
[3] MarketResearch.com. (2022). OTC Cold and Allergy Market Outlook.

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