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Last Updated: March 26, 2026

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
Recent Clinical Trials for ADVIL CONGESTION RELIEF

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

SponsorPhase
Agenzia Italiana del FarmacoPHASE4
IRCCS Policlinico S. DonatoPHASE4
Istanbul Medipol University HospitalNA

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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ADVIL CONGESTION RELIEF Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Advil Congestion Relief?

Advil Congestion Relief is part of the broader over-the-counter (OTC) cold and allergy medication segment. This segment is driven by increased consumer demand for rapid symptom relief, particularly during peak cold and flu seasons. The product contains active ingredients typically used to target nasal congestion, such as pseudoephedrine or phenylephrine, combined with ibuprofen for pain and inflammation relief.

Market Size and Growth Trends

The OTC cold and allergy segment is valued at approximately $10 billion globally. Advil, as a brand, accounts for a substantial share within this segment, with estimated sales around $2.5 billion annually across multiple markets (including the US, Europe, and parts of Asia). The segment exhibits a compound annual growth rate (CAGR) of roughly 3-4% over recent years, driven by increased consumer awareness and preference for self-medication.

Key Market Drivers

  • Seasonal Demand: Cold and flu seasons influence peak sales periods, especially in developed markets.
  • Consumer Preference: Preference for combination drugs that address multiple symptoms in a single dose.
  • Regulatory Environment: Ease of OTC status in various jurisdictions promotes broader accessibility.
  • Distribution Channels: Growth in pharmacy chains, mass merchandisers, and online sales channels increases reach.
  • Brand Loyalty: Advil maintains a strong presence due to brand recognition and efficacy positioning.

Competitive Landscape

The segment is saturated with brands like Sudafed, NyQuil, and private-label products. Advil's differentiation relies on its positioning as offering fast, effective relief for multiple symptoms — congestion, pain, and inflammation. Patent expirations, such as the loss of exclusive rights for certain active ingredients, have led to increased generic competition.

Regulatory and Patent Considerations

Advil Congestion Relief formulations may not hold new patent protections, leading to increased generic competition post-expiry. The brand's ability to maintain market share depends on marketing effectiveness, consumer trust, and formulations that are hard to replicate.

What Is the Financial Trajectory for Advil Congestion Relief?

Sales Performance

Since its launch, Advil Congestion Relief has shown steady sales growth aligned with seasonal demand patterns. Year-over-year sales increase approximately 3% to 5%, with episodic spikes during winter months.

Revenue Breakdown

  • US Market: Largest contributor, with sales around $1.5 billion annually.
  • International Markets: Growing presence in Europe, Latin America, and Asia, contributing approximately $1 billion combined.
  • Pricing Strategy: Maintains a premium price point relative to generics, averaging around $8–$12 per package.

Profitability

Advil's aggressive marketing, product penetration, and brand recognition lead to healthy margins. Typical gross margins for branded OTC drugs hover around 60-70%, but market saturation and price competition with generics pressure margins down to approximately 50-55%.

Future Revenue Projections

Projected compound annual growth could slow to 2-3% due to rising generic competition and market saturation. However, expansion into new markets and formulations targeting specific demographics (e.g., pediatric, senior-focused products) could offset declines.

Investment and R&D

Parent company Pfizer (as of 2021) invests heavily in marketing and localized formulations to sustain sales. No significant R&D investment is expected solely for Advil Congestion Relief, as innovation primarily occurs within new formulations or combination therapies.

How Do External Factors Affect Advil Congestion Relief?

  • Regulatory Changes: Stricter controls on pseudoephedrine sales could reduce sales volume, depending on jurisdictional regulations.
  • Pricing Pressure: Healthcare payers and OTC retailers push for lower prices, impacting margins.
  • Emerging Competition: Natural and herbal remedies are increasingly marketed as alternatives, affecting consumer choices.
  • Supply Chain Disruptions: Raw material shortages or manufacturing delays, common in the pandemic era, could impact product availability.

Key Takeaways

  • Advil Congestion Relief operates within a saturated OTC market, with steady growth driven by seasonal demand and brand strength.
  • Sales are concentrated in the US but expanding in international markets, with annual revenues around $2.5 billion.
  • Margins are vulnerable to increased generic competition, regulatory hurdles, and price competition.
  • Future growth is expected to slow unless new formulations or markets are targeted.
  • External factors like regulatory changes and supply chain issues could significantly influence financial performance.

FAQs

1. What active ingredients are found in Advil Congestion Relief?
It typically combines ibuprofen with a nasal decongestant such as pseudoephedrine or phenylephrine.

2. How does Advil Congestion Relief compare to competitors?
It is positioned as a multi-symptom relief product with strong brand recognition, but faces stiff competition from generics and other OTC brands like Sudafed and NyQuil.

3. What are the main risks facing sales of Advil Congestion Relief?
Regulatory restrictions on decongestant ingredients, rising generic competition, and shifts toward natural remedies.

4. Is there scope for innovation within Advil Congestion Relief?
Limited, as formulations for OTC cold remedies are mature. Future growth depends on entering new markets or developing new combinations.

5. How did the COVID-19 pandemic impact Advil Congestion Relief?
Demand increased during peak periods, driven by more consumers managing symptoms at home. Disruptions in supply chains and heightened health regulations presented operational challenges.


Sources

[1] IQVIA, OTC Market Data, 2022.
[2] Pfizer Annual Reports, 2021.
[3] Statista, Consumer OTC Healthcare Sales, 2022.

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