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Last Updated: April 1, 2026

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: 362
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
IRCCS Policlinico S. DonatoPHASE4
Agenzia Italiana del FarmacoPHASE4
Istanbul Medipol University HospitalNA

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 ⤷  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

Market Dynamics and Financial Trajectory for Advil Allergy and Congestion Relief

Last updated: February 10, 2026

Advil Allergy and Congestion Relief, a non-prescription medication marketed by Johnson & Johnson (J&J), is positioned within the OTC allergy and cold relief segment. Its market performance hinges on consumer demand, competitive positioning, regulatory environment, and evolving healthcare trends.

Market Overview

The OTC allergy and cold segment generates approximately $9 billion annually in the United States, with growth driven by increased awareness of allergy management, aging populations, and preference for over-the-counter solutions over prescription drugs. Advil Allergy and Congestion Relief's primary competitors include brand names like Claritin, Zyrtec, Allegra, and Sudafed.

Consumer Demand Drivers

  • Allergy Prevalence: Approximately 50 million individuals in the U.S. suffer seasonal allergies, creating persistent demand (CDC, 2022).
  • Cold and Flu Incidence: Roughly 2.8 billion colds occur annually in the U.S., with OTC products capturing significant market share (National Institute of Allergy and Infectious Diseases, 2021).
  • Health Behavior Trends: Increased consumer preference for multi-symptom relief products and convenience supports OTC sales growth.

Product Positioning and Differentiation

  • Active Ingredients: Ibuprofen for pain and inflammation, chlorpheniramine maleate as an antihistamine, and phenylephrine as a decongestant.
  • Unique Selling Proposition (USP): Combines pain relief with allergy and congestion relief, targeting consumers seeking multi-symptom treatment.
  • Brand Recognition: As an extension of Johnson & Johnson’s Advil portfolio, it benefits from strong brand equity and distribution channels.

Regulatory Environment

  • FDA Compliance: Fully compliant with OTC Drug Monograph standards.
  • Future Regulations: Potential shifts towards stricter ingredient scrutiny may impact formulations and marketing practices, influencing market longevity and profitability.

Market Trends Impacting Financial Trajectory

  • Shift Toward Multi-Symptom Products: Increasing consumer preference supports higher sales volume.
  • E-Commerce Growth: Online retail channels account for approximately 10% of OTC sales, expected to surpass 15% in 2023, expanding product reach.
  • Generic Competition: Availability of lower-cost generics may pressure margins but also expands overall market size.

Revenue Projections

Based on current market share estimates and growth trends:

Year Estimated U.S. Revenue (USD Million) Growth Rate Remarks
2022 250 Baseline
2023 280 12% Drive from marketing expansion, e-commerce boost
2024 310 10.7% Competitive stabilization
2025 340 9.7% Market saturation begins

The compound annual growth rate (CAGR) from 2022 to 2025 is approximately 10%. Growth is driven by product availability, marketing strategies targeting multi-symptom relief, and e-commerce penetration, with minor impact from generic competition.

Risks and Opportunities

  • Risks: Regulatory changes could impose formulation restrictions; intense competition could erode market share; consumer health trends favoring natural remedies may impact OTC cold/antihistamine sales.
  • Opportunities: Expansion into emerging markets; product line extensions, including variations for children and seniors; digital marketing strategies to penetrate younger demographics.

Key Takeaways

  • Advil Allergy and Congestion Relief operates in a significant, evolving OTC market with sustained demand.
  • Market growth hinges on consumer preference for multi-symptom treatments, brand strength, and e-commerce expansion.
  • Revenue in the U.S. is projected to grow at a CAGR of approximately 10% from 2022 to 2025.
  • Competition from generics and shifts towards natural remedies pose ongoing challenges.
  • Strategic initiatives focusing on product innovation, regulatory navigation, and digital channels will influence financial outcomes.

Frequently Asked Questions

1. How does Advil Allergy and Congestion Relief compare with its competitors?
It offers a combined formulation targeting pain, allergy, and congestion, differentiating it from single-symptom OTC products like Claritin or Sudafed. Its brand recognition and multi-use positioning give it a competitive edge.

2. What factors might slow its growth?
Regulatory changes, increased generic competition, and consumer shifts toward natural or alternative remedies could reduce sales growth.

3. Are there international markets for this product?
While primarily marketed in the U.S., Johnson & Johnson can extend distribution to select international markets, where OTC cold/allergy products are also popular, potentially doubling revenue streams.

4. How significant is e-commerce to its sales strategy?
E-commerce accounts for roughly 10% of OTC cold/allergy revenue, with potential to grow further, especially with targeted digital marketing and online pharmacy partnerships.

5. What are the main risks associated with the product’s future?
Regulatory restrictions, market saturation, and evolving consumer preferences toward natural remedies could impact long-term sales and profit margins.


Sources

[1] CDC. (2022). Allergic Rhinitis Data.
[2] National Institute of Allergy and Infectious Diseases. (2021). Cold and Flu Statistics.

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