ADVIL DUAL ACTION WITH ACETAMINOPHEN Drug Patent Profile

Which patents cover Advil Dual Action With Acetaminophen, and when can generic versions of Advil Dual Action With Acetaminophen launch?

Advil Dual Action With Acetaminophen is a drug marketed by Haleon Us Holdings and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fourteen patent family members in twelve countries.

The generic ingredient in ADVIL DUAL ACTION WITH ACETAMINOPHEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; ibuprofen profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Advil Dual Action With Acetaminophen

A generic version of ADVIL DUAL ACTION WITH ACETAMINOPHEN was approved as acetaminophen; ibuprofen by L PERRIGO CO on February 28^th, 2023.

Summary for ADVIL DUAL ACTION WITH ACETAMINOPHEN

International Patents:	14
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	92
What excipients (inactive ingredients) are in ADVIL DUAL ACTION WITH ACETAMINOPHEN?	ADVIL DUAL ACTION WITH ACETAMINOPHEN excipients list
DailyMed Link:	ADVIL DUAL ACTION WITH ACETAMINOPHEN at DailyMed

Recent Clinical Trials for ADVIL DUAL ACTION WITH ACETAMINOPHEN

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

Sponsor	Phase
Wolfson Medical Center	PHASE4
Massachusetts General Hospital	PHASE3
Beth Israel Deaconess Medical Center	PHASE3

See all ADVIL DUAL ACTION WITH ACETAMINOPHEN clinical trials

Pharmacology for ADVIL DUAL ACTION WITH ACETAMINOPHEN

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Paragraph IV (Patent) Challenges for ADVIL DUAL ACTION WITH ACETAMINOPHEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADVIL DUAL ACTION WITH ACETAMINOPHEN	Tablets	acetaminophen; ibuprofen	125 mg/250 mg	211733	2	2024-03-28

US Patents and Regulatory Information for ADVIL DUAL ACTION WITH ACETAMINOPHEN

ADVIL DUAL ACTION WITH ACETAMINOPHEN is protected by one US patents.

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 DUAL ACTION WITH ACETAMINOPHEN	acetaminophen; ibuprofen	TABLET;ORAL	211733-001	Feb 28, 2020		OTC	Yes	Yes			Y

International Patents for ADVIL DUAL ACTION WITH ACETAMINOPHEN

See the table below for patents covering ADVIL DUAL ACTION WITH ACETAMINOPHEN around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3143724
European Patent Office	3989944
Australia	2024200875
South Korea	20220027194
Japan	7703220
World Intellectual Property Organization (WIPO)	2020263947

Market Dynamics and Financial Trajectory for Advil Dual Action with Acetaminophen

Last updated: July 27, 2025

Introduction

Advil Dual Action with Acetaminophen represents a strategic evolution within the over-the-counter (OTC) analgesic market, designed to combine the anti-inflammatory effects of ibuprofen with the centrally acting analgesic properties of acetaminophen (paracetamol). Its emergence aligns with consumer preference for multi-symptom relief formulations, emphasizing both efficacy and convenience. Understanding the product’s market dynamics and financial trajectory requires an analytical approach focused on consumer behavior, regulatory landscape, competitive positioning, and broader healthcare trends.

Market Landscape and Consumer Demand

The OTC analgesic segment has experienced sustained growth driven by increasing global demand for pain management solutions that provide rapid, effective relief without prescription requirements. The analgesic market is forecasted to reach approximately $20 billion by 2025, reflecting an annual compound growth rate (CAGR) of about 4-5% [1].

Consumer preferences now prioritize combination therapies that mitigate side effects and enhance efficacy. Advil Dual Action fits this trend by offering a dual mechanism—ibuprofen’s anti-inflammatory activity combined with acetaminophen’s pain relief—appealing to consumers seeking comprehensive symptom management. This demand is particularly prominent among middle-aged and elderly demographics, managing chronic pain, and consumers seeking quick relief for acute ailments.

The rise of personalized healthcare and increased health literacy have further bolstered the segment’s prospects, fostering demand for OTC products that can be tailored to specific pain profiles while emphasizing safety. However, concerns over the safety profile of acetaminophen, notably hepatotoxicity at high doses, introduce regulatory and consumer considerations affecting market dynamics.

Regulatory Environment and Safety Constraints

Regulatory agencies, including the U.S. Food and Drug Administration (FDA), impose strict guidelines on OTC analgesics, especially regarding dosing and safety warnings. Acetaminophen, although widely used, carries a risk of liver toxicity with overdose, prompting regulatory measures such as dosage limits (generally 3,000–4,000 mg per day) and clear labeling.

In response, manufacturers like Johnson & Johnson (Advil’s parent company) have increasingly integrated safety warnings into packaging and marketing strategies. Regulatory scrutiny may impact product formulation, dosing recommendations, and sales trajectories. Any future restrictions or public health advisories related to acetaminophen could influence sales and product acceptance.

Competitive Dynamics and Market Positioning

The analgesic market features fierce competition from established brands like Tylenol (acetaminophen), Motrin (ibuprofen), Aleve (naproxen), and store brands. Advil Dual Action's competitive advantage stems from its dual mechanism, appealing to consumers who want rapid, multi-symptom relief without increasing pill burden.

However, the market is heavily commoditized, with price-sensitive consumers and private label products exerting downward pressure on margins. Brand loyalty, targeted marketing, and product differentiation are crucial. Advil’s established reputation for fast relief and safety profiles positions it favorably, but continuous innovation remains vital.

Moreover, the recent surge in consumer interest in natural remedies and alternative therapies poses a potential challenge. The company's strategic focus on FDA-approved, evidence-backed formulations helps maintain credibility amid shifting consumer preferences.

Pharmacoeconomic and Healthcare Trends

The growing emphasis on opioid-sparing pain management solutions enhances OTC analgesic market growth. These formulations serve as first-line options for mild to moderate pain, reducing healthcare costs and opioid exposure risks. Advil Dual Action with Acetaminophen aligns with this shift, offering an effective alternative, especially for policy-makers advocating for non-prescription pain relief options.

Additionally, aging populations and increasing prevalence of chronic pain conditions globally further expand market opportunities. As health systems worldwide prioritize accessible, cost-effective medications, OTC combination analgesics gain prominence, supported by reimbursements and health policy incentives, which could further bolster sales.

Financial Trajectory and Revenue Projections

Forecasting the financial trajectory for Advil Dual Action hinges on several factors: market penetration, sales growth, regulatory environment, and pipeline innovations. Assuming consistent marketing and favorable consumer reception, sales are projected to grow at a CAGR of 4-6% over the next five years [2].

Historically, Advil has experienced resilient growth within Johnson & Johnson’s OTC portfolio, with annual revenues reaching over $1 billion globally. The dual-action variant is expected to contribute a growing share of this figure due to its differentiated positioning. Expansion into emerging markets could catalyze additional revenue streams, given rising disposable incomes and increasing awareness of OTC analgesics.

Furthermore, innovations such as flavor extensions, dosage form improvements (e.g., dissolvable tablets), and targeted marketing campaigns could accelerate sales growth. The integration of digital health platforms to educate consumers and promote adherence also presents opportunities to enhance market share.

Challenges Impacting Financial Performance

Despite positive outlooks, several challenges threaten to impact the financial trajectory:

• Regulatory Risks: Stringent safety warnings linked to acetaminophen may limit dosing or recommend usage restrictions, possibly dampening consumer appeal.
• Market Saturation: High competition and generic prevalence could exert price pressure, reducing margins.
• Public Perception: Concerns over hepatotoxicity or safety in specific populations (e.g., alcohol consumers) may hinder adoption.
• Supply Chain Dynamics: Global disruptions, such as raw material shortages or manufacturing delays, can affect product availability and sales.

Conclusion and Strategic Outlook

Advil Dual Action with Acetaminophen is positioned at the nexus of evolving consumer demand for effective, safe, multi-mechanism OTC analgesics. Its financial trajectory over the next five years will likely mirror the broader OTC pain relief market’s growth, with potential for acceleration through innovation, expansion into new markets, and strategic marketing.

To capitalize on this opportunity, Johnson & Johnson should prioritize safety communication, leverage digital channels for consumer engagement, and explore formulation innovations. Regulatory vigilance remains critical to navigate safety warnings and maintain product credibility.

In summary, Advil Dual Action’s market dynamics are shaped by consumer preferences, regulatory constraints, and competitive intensity, with a promising financial trajectory contingent on effective execution and market conditions.

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Key Takeaways

• The OTC analgesic market is projected to grow steadily, driven by increasing demand for combination therapies.
• Consumer preference for fast, multi-symptom relief aligns with Advil Dual Action’s dual mechanism, positioning it favorably.
• Regulatory environments requiring safety warnings on acetaminophen necessitate vigilant compliance, influencing product marketing and sales.
• Competitive pressure from generic and store-brand products underscores the importance of brand loyalty and product differentiation.
• Strategic innovation and expansion into emerging markets can accelerate revenue growth, with a projected CAGR of 4-6% over five years.

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FAQs

Q1: How does Advil Dual Action differentiate itself from other OTC pain relievers?
A1: It combines ibuprofen’s anti-inflammatory properties with acetaminophen’s central analgesic effects, offering comprehensive relief in a single formulation, addressing a broader range of pain types and improving consumer convenience.

Q2: What are the main safety considerations for Advil Dual Action?
A2: The primary concern revolves around acetaminophen’s hepatotoxicity at high doses. Clear dosing guidelines, safety warnings, and consumer education are essential to mitigate risks.

Q3: How might regulatory changes impact Advil Dual Action’s market?
A3: Stricter regulations on acetaminophen dosing or usage warnings could limit consumer uptake or require reformulation, potentially affecting sales and market positioning.

Q4: What growth opportunities exist internationally for Advil Dual Action?
A4: Emerging markets with rising disposable incomes and increased health awareness provide expansion potential, especially with localized marketing and distribution strategies.

Q5: What strategies can Johnson & Johnson adopt to sustain Advil Dual Action’s market share?
A5: Continuous product innovation, targeted marketing emphasizing safety and efficacy, expansion into new markets, and leveraging digital health platforms will be key.

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Sources

[1] MarketWatch. Global OTC analgesics market size and forecasts.
[2] Johnson & Johnson financial reports and industry analyses.