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 fifteen 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. Fifty-one 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:	15
US Patents:	1
Applicants:	1
NDAs:	1

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
Australia	2024200875	NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION
European Patent Office	3989944	NOUVELLE COMPOSITION D'IBUPROFÈNE ET D'ACÉTAMINOPHÈNE (NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION)
Japan	2025134843	新規なイブプロフェン及びアセトアミノフェン組成物 (NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION)
Japan	2022540348	新規なイブプロフェン及びアセトアミノフェン組成物

Investment Scenario and Fundamentals Analysis for Advil Dual Action with Acetaminophen

Last updated: February 20, 2026

What is the market position of Advil Dual Action with Acetaminophen?

Advil Dual Action with Acetaminophen is a combined analgesic and antipyretic marketed by Pfizer. It addresses consumer demand for multi-mechanism pain relief in OTC settings. The formulation includes 200 mg ibuprofen and 500 mg acetaminophen per tablet, targeting moderate pain, inflammation, and fever.

Regulatory status and patent landscape

The drug is marketed as an OTC medication with established approval by the FDA. Its patent has expired, which is typical for combination analgesics developed over a decade ago. No current patents protect the dual formulation, allowing generic competitors to enter the market.

Competitive positioning

Advil Dual Action competes directly with single-ingredient products such as Tylenol (acetaminophen) and Advil (ibuprofen). It offers a differentiation in combining both active ingredients in a single dose, catering to consumers seeking multi-ingredient relief.

Market size and growth dynamics

The global OTC analgesic market was valued at approximately $17 billion in 2022, with a compound annual growth rate (CAGR) of around 4.2% projected through 2028 (QY Research, 2022). The segment for combination pain relievers is expanding, driven by consumer preference for multi-mechanism products.

Key market drivers:

• Rising prevalence of chronic pain conditions.
• Growth in aging populations.
• Increasing awareness of OTC options for pain management.
• Consumer trends favoring convenience.

Market challenges:

• Regulatory scrutiny around safety, particularly concerning acetaminophen’s hepatotoxicity.
• Competition from innovative OTC formulations.
• Potential shifts in dosing recommendations and labeling regulations.

Financial outlook and investment considerations

Since the active patents are expired, the revenue from Advil Dual Action relies primarily on brand loyalty and consumer preference. The overall market stability is influenced by the volume of OTC sales and price competition. Pfizer continues to invest in marketing but faces generic price erosion.

Projected revenue impact is limited unless Pfizer introduces new formulations or expands indications. The product's contribution to Pfizer's OTC portfolio remains stable but not growth-driving.

Risks and opportunities

Risks:

• Regulatory changes increasing restrictions on acetaminophen, affecting formulation viability.
• Competition from generic brands reducing market share.
• Consumer safety concerns impacting brand reputation.

Opportunities:

• Formulation enhancements to improve safety profiles.
• Expansion into emerging markets with growing OTC demand.
• Combination with other ingredients for broader indications.

Strategic considerations

Investors should analyze Pfizer's overall OTC portfolio, regulatory environment shifts, and competitors' pipeline developments. Focus on emerging markets and potential reformulations remains key to assessing long-term value.

Key market and regulatory insights

Aspect	Details
Patent status	Expired for this combination product
Regulatory approvals	FDA OTC approval; EU registration varies
Competition	Generics dominate post-patent expiration
Consumer trends	Preference for multimodal OTC products
Market growth	4.2% CAGR projected until 2028

Summary

Advil Dual Action with Acetaminophen is a mature product in a highly competitive, mature OTC analgesic market. The lack of patent protection limits revenue growth potential, but the product's consumer loyalty and market stability provide steady cash flow. Strategic growth hinges on formulation innovation and expansion into markets with increasing OTC demand.

Key Takeaways

• The product faces intense generic competition due to patent expiry.
• Market growth depends on consumer preferences for combination analgesics.
• Regulatory scrutiny for acetaminophen safety remains a risk.
• Opportunities exist through geographic expansion and product reformulation.
• Pfizer’s future success will depend on broader OTC portfolio strategies and innovation.

FAQs

1. How does Advil Dual Action with Acetaminophen compare to single-ingredient competitors?
It offers the convenience of combined pain relief, potentially increasing adherence for consumers seeking multi-mechanism treatment, but lacks patent protection and faces price competition from generics.

2. What are regulatory concerns related to acetaminophen?
Increased warnings regarding hepatotoxicity and dosage limits may reduce consumer use or lead to reformulation, impacting sales.

3. Can patent differences influence its market longevity?
Patent expiration means generic competitors can produce identical formulations, pressuring prices and margins.

4. What expansion opportunities exist for this product?
Investments in emerging markets and potential future formulations that improve safety profiles could extend market relevance.

5. How might future regulatory actions affect this product?
Stricter dosing guidelines and safety warnings could limit usage, influence labeling, and necessitate reformulation for continued market access.

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References

1. QY Research. (2022). Global OTC analgesics market report.
2. U.S. Food and Drug Administration. (2022). OTC drug review and safety information.
3. Pfizer Inc. Annual Reports. (2022). Over-the-counter product portfolio.
4. MarketWatch. (2022). Analgesics market analysis and forecast.
5. European Medicines Agency. (2022). Safety updates on acetaminophen.