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 twelve patent family members in eleven countries.

The generic ingredient in ADVIL DUAL ACTION WITH ACETAMINOPHEN is acetaminophen; ibuprofen. There are sixty-six drug master file entries for this compound. Thirty-eight 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:	12
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Clinical Trials:	86
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
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4
Wayne State University	N/A
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	Phase 2

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
World Intellectual Property Organization (WIPO)	2020263947
Brazil	112021026407	Composição de ibuprofeno e acetaminofeno
Mexico	2021016089	COMPOSICIÓN NOVEDOSA DE IBUPROFENO Y ACETAMINOFENO. (NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION.)
Australia	2020301401	Novel ibuprofen and acetaminophen composition
China	114173767	布洛芬和对乙酰氨基酚的新型组合物 (Novel composition of ibuprofen and acetaminophen)
European Patent Office	3989944	NOUVELLE COMPOSITION D'IBUPROFÈNE ET D'ACÉTAMINOPHÈNE (NOVEL IBUPROFEN AND ACETAMINOPHEN COMPOSITION)
South Korea	20220027194	신규 이부프로펜 및 아세트아미노펜 조성물

ADVIL DUAL ACTION WITH ACETAMINOPHEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Advil Dual Action with Acetaminophen

Introduction

In 2020, GlaxoSmithKline (GSK) made a significant mark in the over-the-counter (OTC) pain relief market with the FDA approval of Advil Dual Action with Acetaminophen. This innovative product combines ibuprofen and acetaminophen, two widely used pain relievers, into a single formulation. Here, we delve into the market dynamics and financial trajectory of this groundbreaking drug.

Market Need and Demand

The demand for effective pain relief medications has been steadily increasing, driven by the rising prevalence of chronic disorders such as arthritis, backaches, and other joint pains. The COVID-19 pandemic further accelerated this demand as patients sought reliable treatments for pain and fever, contributing to a surge in the sales of pain-relieving medications like acetaminophen[5].

Unique Selling Proposition

Advil Dual Action with Acetaminophen is the first FDA-approved OTC combination of ibuprofen and acetaminophen in the United States. This unique formulation leverages the different mechanisms of action of both ingredients: ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), reduces prostaglandins to alleviate pain and inflammation, while acetaminophen blocks pain signals to the brain. This dual-action approach provides superior efficacy compared to using either medication alone[2][3][4].

Clinical Efficacy and Safety

The approval of Advil Dual Action was supported by data from seven clinical studies, including three pivotal efficacy and safety studies. These studies demonstrated that the fixed-dose combination of ibuprofen and acetaminophen achieves superior pain relief compared to the individual components. The product has been shown to provide relief for multiple symptoms, including headaches, toothaches, backaches, menstrual cramps, and minor arthritis pain[2][3][4].

Regulatory Approval

The FDA approval in February 2020 marked a significant milestone for GSK, allowing Advil Dual Action to be available OTC nationwide in the United States. This approval was a result of rigorous clinical testing and consumer studies that ensured the product's safety and efficacy for consumers aged 12 and older[1][2][4].

Market Impact

The introduction of Advil Dual Action has significantly impacted the OTC pain relief market. As the No. 1 selling OTC pain reliever, Advil's new formulation offers consumers a convenient and effective alternative to using separate ibuprofen and acetaminophen products. This has likely increased market share for GSK in the pain relief segment, attracting consumers who value the convenience and enhanced efficacy of a single, dual-action product[2][4].

Financial Trajectory

The financial trajectory for Advil Dual Action is promising, given its unique positioning and the strong demand for pain relief medications. Here are some key financial aspects:

Revenue Growth

The launch of Advil Dual Action is expected to drive revenue growth for GSK's Consumer Healthcare division. The product's superior efficacy and convenience are likely to attract a significant market share, contributing to increased sales and revenue.

Market Share

As the first FDA-approved OTC combination of ibuprofen and acetaminophen, Advil Dual Action is poised to capture a substantial share of the pain relief market. This could lead to a competitive edge over other pain relief products, further solidifying GSK's position as a leader in the market[2][3][4].

Consumer Adoption

Consumer testing has shown that consumers understand the benefits and risks of the product, including the risk of liver toxicity when combining with other acetaminophen products. This understanding, coupled with the product's superior efficacy, is expected to drive high consumer adoption rates[1].

Competitive Landscape

The approval of Advil Dual Action has set a new standard in the OTC pain relief market. Competitors may need to innovate to match the efficacy and convenience offered by this dual-action formulation. GSK's commitment to providing safe, effective, and convenient pain relief options, as evidenced by the approval of Voltaren Arthritis Pain gel around the same time, further strengthens its market position[2][4].

Consumer Behavior and Preferences

Consumers have historically used ibuprofen and acetaminophen separately to treat various pain conditions. The availability of a single product that combines both ingredients addresses a long-standing consumer need for convenience and efficacy. This aligns with consumer preferences for easy-to-use, effective treatments that can be managed without the need for multiple medications[2][4].

Safety and Risk Management

While the product offers superior efficacy, it also comes with specific safety considerations. Consumers are cautioned against combining Advil Dual Action with other products containing acetaminophen or NSAIDs to avoid increased risks of adverse reactions such as liver toxicity and gastrointestinal bleeding. Clear labeling and consumer education are crucial in managing these risks[1].

Global Market Potential

The success of Advil Dual Action in the U.S. market could pave the way for its introduction in other regions. Given the global demand for effective pain relief medications, especially in regions like North America and the Asia Pacific, where chronic disorders are prevalent, the product has significant global market potential[5].

Key Takeaways

• First FDA-Approved Combination: Advil Dual Action is the first FDA-approved OTC combination of ibuprofen and acetaminophen in the United States.
• Superior Efficacy: The product demonstrates superior pain relief compared to individual components.
• Market Impact: It has significantly impacted the OTC pain relief market, offering consumers a convenient and effective alternative.
• Financial Trajectory: Expected to drive revenue growth and capture a substantial market share.
• Consumer Adoption: High consumer adoption rates due to its convenience and efficacy.
• Global Potential: Significant potential for expansion into other regions.

FAQs

Q: What is Advil Dual Action with Acetaminophen?

A: Advil Dual Action with Acetaminophen is an OTC pain relief medication that combines ibuprofen and acetaminophen in a single formulation.

Q: What are the benefits of using Advil Dual Action?

A: It provides superior pain relief compared to using ibuprofen or acetaminophen alone, and offers the convenience of a single product.

Q: What are the potential risks associated with Advil Dual Action?

A: Potential risks include liver toxicity, gastrointestinal bleeding, and skin reactions, especially when combined with other products containing acetaminophen or NSAIDs.

Q: Who is the target market for Advil Dual Action?

A: The product is intended for consumers aged 12 and older who experience minor aches and pains due to various conditions.

Q: How does Advil Dual Action compare to other pain relief products?

A: It is the first FDA-approved OTC combination of ibuprofen and acetaminophen, offering superior efficacy and convenience compared to separate products.

Sources

1. FDA Approval Document: "Advil Dual Action with Acetaminophen" - FDA.
2. PR Newswire: "FDA Approves GSK's Advil Dual Action with Acetaminophen for Over-the-Counter Use in the United States" - PR Newswire.
3. GSK Press Release: "FDA Approves GSK's Advil Dual Action with Acetaminophen for Over-the-Counter Use in the United States" - GSK.
4. GSK Media Release: "FDA Approves GSK's Advil Dual Action with Acetaminophen for Over-the-Counter Use in the United States" - GSK.
5. Fortune Business Insights: "Acetaminophen Market Size, Industry Share | Forecast, 2032" - Fortune Business Insights.