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Last Updated: December 12, 2025

ADVIL Drug Patent Profile


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When do Advil patents expire, and what generic alternatives are available?

Advil is a drug marketed by Haleon Us Holdings and is included in eleven NDAs. There are two patents protecting this drug.

The generic ingredient in ADVIL is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.

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Summary for ADVIL
Drug patent expirations by year for ADVIL
Drug Prices for ADVIL

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Pharmacology for ADVIL

US Patents and Regulatory Information for ADVIL

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 ibuprofen TABLET;ORAL 018989-001 May 18, 1984 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
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
Haleon Us Holdings ADVIL ALLERGY SINUS chlorpheniramine maleate; ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 021441-001 Dec 19, 2002 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Haleon Us Holdings ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393-001 Dec 21, 2005 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Haleon Us Holdings ADVIL DUAL ACTION WITH ACETAMINOPHEN acetaminophen; ibuprofen TABLET;ORAL 211733-001 Feb 28, 2020 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Haleon Us Holdings ADVIL ibuprofen sodium TABLET;ORAL 201803-001 Jun 12, 2012 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

EU/EMA Drug Approvals for ADVIL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Rare Diseases Pedea ibuprofen EMEA/H/C/000549Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age. Authorised no no no 2004-07-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for ADVIL

Last updated: July 27, 2025

Introduction

Ibuprofen, marketed under the brand name ADVIL among others, remains a dominant non-prescription analgesic and anti-inflammatory drug globally. Its extensive market penetration, robust sales performance, and the evolving landscape of consumer health segments underscore its significance in the pharmaceutical industry. Understanding the future market trajectory and key dynamics shaping ADVIL’s financial performance is crucial for stakeholders, including investors, manufacturers, and healthcare providers.

Market Overview

Advil, introduced by Pfizer in the early 1980s, has established itself as a leading over-the-counter (OTC) pain management medication. With a broad consumer base spanning multiple demographics and geographies, it benefits from longstanding brand recognition and a wide distribution network. The global anti-inflammatory market, valued at approximately USD 44 billion in 2022, is projected to expand at a compound annual growth rate (CAGR) of around 5.2% through 2030[1].

Key drivers include the growing prevalence of chronic pain conditions, an aging population, and consumer preference for OTC solutions over prescription drugs. Furthermore, increased awareness of self-medication and the expanding availability of OTC analgesics in emerging markets enhance ADVIL’s growth prospects.

Market Dynamics

1. Competitive Landscape

The anti-inflammatory and analgesic segment is highly competitive, with key players like Johnson & Johnson (Advil’s primary competitor in US markets), Bayer, and Sanofi. These corporations often engage in aggressive marketing, brand extensions, and new product launches to capture market share. The entrance of low-cost, private-label counterparts further adds price competition pressure. Nonetheless, ADVIL’s strong branding and proven efficacy maintain a competitive edge.

2. Regulatory Environment

Regulatory agencies worldwide, notably the US Food and Drug Administration (FDA), impose stringent standards for OTC drugs. These regulations shape product formulations, labeling, and permissible dosages. Pfizer’s ongoing compliance and proactive engagement with regulatory bodies have historically supported ADVIL’s market access. However, potential regulatory changes, especially regarding abuse potential or safety profiles, could impact product availability and formulation strategies.

3. Consumer Trends

Increasing consumer awareness about pain management options fuels demand. Historically, consumers favored acetaminophen (paracetamol) for mild pain; however, concerns over liver toxicity associated with high-dose acetaminophen have shifted preferences toward NSAIDs like ibuprofen. Furthermore, preferences for natural or organic labels in health supplements influence consumer choices, prompting innovation among competitors.

4. Innovation and Product Diversification

To sustain growth, Pfizer has developed variations of ADVIL, including gels, caplets, and formulations with added ingredients targeting specific demographics (e.g., children, seniors). The expansion into combination products, such as analgesic plus cold relief, aligns with consumer demand for multi-purpose formulations. Technological advancements, including faster absorption and longer-lasting effects, further influence market offerings.

5. Pricing Strategies

Pricing remains pivotal, particularly given OTC products’ sensitivity to consumer spending. Pfizer’s strategic pricing, promotional campaigns, and distribution partnerships in emerging markets facilitate accessibility. Price erosion due to generics and private labels pressures margins but can augment volume sales.

Financial Trajectory

1. Revenue Streams

ADVIL’s revenue primarily derives from domestic US sales and international markets, with North America comprising approximately 65% of total OTC analgesic sales[2]. Pfizer’s diversified portfolio, including other OTC and prescription medications, synergizes with ADVIL’s sales, offering cross-promotional opportunities.

2. Impact of Patent Expiry and Generics

While ADVIL’s core formulation is off-patent, Pfizer’s competitive advantage stems from brand recognition, formulation quality, and distribution reach. Generics and store brands challenge profit margins but usually do not significantly impair sales volume owing to brand loyalty. Price competition from generics can lead to reduced average selling prices, impacting profitability.

3. Regulatory and Safety Proceedings

Any safety concerns or regulatory restrictions related to NSAIDs, such as gastrointestinal or cardiovascular risks, could influence sales. The FDA’s safety warnings or new guidelines may result in product recalls, label modifications, or usage restrictions that could impact revenue streams.

4. R&D and Strategic Investments

Pfizer invests significantly in R&D for formulation improvements and expanding indications. For instance, ongoing research into safer NSAID equivalents and targeted delivery systems may open new revenue avenues. Strategic acquisitions or partnerships could also expand ADVIL’s market presence and product pipeline.

5. Market Expansion Opportunities

Emerging markets present substantial growth potential owing to rising disposable incomes, healthcare infrastructure improvements, and increasing demand for OTC products. Pfizer’s focus on entering Latin America, Asia-Pacific, and Africa aligns with the broader global health trend, promising long-term revenue gains.

Future Market Outlook

The outlook for ADVIL’s financial performance appears strong, influenced by demographic trends, consumer behavior shifts, and innovation. Analysts project a CAGR of 4-6% in OTC analgesic sales through 2030, with ADVIL positioned to capitalize on its brand equity and market reach[3]. However, sustained competition, regulatory vigilance, and evolving consumer preferences necessitate continuous adaptation to preserve growth trajectories.

Emerging focus areas include developing formulations with enhanced safety profiles, exploring adjunct indications like inflammation-related conditions, and leveraging digital health platforms for marketing and consumer engagement. The overarching trend toward personalized medicine and natural remedies may also subtly influence future demand, encouraging diversification.

Key Takeaways

  • Market Leadership: ADVIL benefits from strong brand recognition, wide distribution, and a loyal consumer base, sustaining its market dominance despite increased competition.
  • Growth Drivers: Aging populations, rising chronic pain prevalence, and consumer preference for OTC options support long-term growth.
  • Competitive Challenges: Intense price competition from generics and store brands, coupled with regulatory scrutiny on NSAIDs’ safety profiles, pose threats.
  • Innovation Strategies: Continuous product innovation, formulation diversification, and market expansion are critical for maintaining competitive advantage.
  • Financial Outlook: While revenue growth is expected to remain positive, margins might face pressure from generics, requiring strategic cost management and differentiation.

FAQs

Q1: How does regulatory risk influence ADVIL’s market outlook?
Regulatory agencies like the FDA monitor NSAID safety closely. Potential safety warnings or restrictions could limit product formulations or usage recommendations, impacting sales. Continuous compliance and safety research are essential to mitigate regulatory risks.

Q2: What role do generics play in ADVIL’s revenue stability?
Generics exert price competition, reducing margins but typically do not significantly affect volume due to brand loyalty. Pfizer’s focus on innovation and branding helps sustain premium pricing and market share.

Q3: Are there upcoming formulations or indications that could boost ADVIL sales?
Research into safer NSAID formulations, combination therapies, and tailored delivery systems could enhance safety profiles and expand indications, driving future sales growth.

Q4: How important are emerging markets for ADVIL’s long-term growth?
Extremely important. Demographic trends, rising healthcare access, and consumer affordability in regions like Asia-Pacific and Latin America offer substantial expansion opportunities.

Q5: What are the primary risks for ADVIL’s market stability?
Regulatory challenges, safety concerns, competitive pressures, and shifts in consumer preferences toward natural remedies or alternative therapies pose ongoing risks.

Sources

  1. MarketWatch, “Global Anti-Inflammatory Drugs Market Outlook,” 2022.
  2. Pfizer Annual Report 2022.
  3. GlobalData, OTC Analgesics Market Analysis, 2022.

Note: The above analysis synthesizes current market intelligence and industry reports to project the future trajectory of ADVIL. Stakeholders are advised to consider dynamic market developments and regulatory changes in strategic planning.

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