EXCEDRIN (MIGRAINE RELIEF) Drug Patent Profile

When do Excedrin (migraine Relief) patents expire, and when can generic versions of Excedrin (migraine Relief) launch?

Excedrin (migraine Relief) is a drug marketed by Haleon Us Holdings and is included in one NDA.

The generic ingredient in EXCEDRIN (MIGRAINE RELIEF) is acetaminophen; aspirin; caffeine. There are sixty-six drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the acetaminophen; aspirin; caffeine profile page.

Summary for EXCEDRIN (MIGRAINE RELIEF)

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	6
Clinical Trials:	1
DailyMed Link:	EXCEDRIN (MIGRAINE RELIEF) at DailyMed

Recent Clinical Trials for EXCEDRIN (MIGRAINE RELIEF)

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

Sponsor	Phase
Albert Einstein Healthcare Network	Phase 4

See all EXCEDRIN (MIGRAINE RELIEF) clinical trials

Pharmacology for EXCEDRIN (MIGRAINE RELIEF)

Drug Class	Central Nervous System Stimulant Methylxanthine Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production

US Patents and Regulatory Information for EXCEDRIN (MIGRAINE 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	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998		OTC	Yes	Yes

Expired US Patents for EXCEDRIN (MIGRAINE RELIEF)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998	4,943,565
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998	5,972,916

International Patents for EXCEDRIN (MIGRAINE RELIEF)

See the table below for patents covering EXCEDRIN (MIGRAINE RELIEF) around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	8170598
Japan	2604599
Germany	69814636
Japan	S6383025	ANALGESIC TABLET OF ASPIRIN, ACETAMINOPHEN AND CAFFEINE CONTAINING LOW SUBSTITUTED HYDROXYPROPYL CELLULOSE
European Patent Office	0994714	COMPOSITION D'ACETAMINOPHENE, D'ASPIRINE, ET DE CAFEINE ATTENUANT LA DOULEUR ET LES SYMPTOMES, DE LA MIGRAINE (USE OF COMPOSITIONS CONTAINING THE COMBINATION OF ACETAMINOPHEN, ASPIRIN AND CAFFEINE TO ALLEVIATE THE PAIN AND SYMPTOMS OF MIGRAINE)
Portugal	994714
Canada	1288349	COMPRIME ANALGESIQUE D'ASPIRINE, ACETAMINOPHEN ET CAFEINE CONTENANT DE L'HYDROXYPROPYLCELLULOSE FAIBLEMENT SUBSTITUE (ANALGESIC TABLET OF ASPIRIN, ACETAMINOPHEN AND CAFFEINE CONTAININGLOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE)

Market Dynamics and Financial Trajectory for EXCEDRIN (Migraine Relief)

Last updated: July 31, 2025

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Introduction

EXCEDRIN, a popular over-the-counter (OTC) analgesic primarily marketed for migraine relief, has enjoyed longstanding visibility within the pharmaceutical and consumer health markets. Its primary formulation combines acetaminophen, aspirin, and caffeine, providing a multi-mechanistic approach to alleviating headache symptoms. As consumer preferences evolve, regulatory considerations tighten, and competitive dynamics shift, understanding the current market landscape and financial trajectory of EXCEDRIN becomes critical for stakeholders.

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Market Overview of Migraine Relief

Migraine remains one of the most prevalent neurological disorders globally, affecting approximately 1 billion people worldwide, with significant socioeconomic impacts and quality-of-life reductions [1]. The global headache medications market, including OTC and prescription categories, was valued at around USD 4.8 billion in 2022 and is projected to grow at a CAGR of approximately 4.2% through 2030 [2].

The OTC segment, which includes products such as EXCEDRIN, represents nearly 35% of this market. Increasing consumer preference for self-managed pain relief, coupled with greater awareness of migraine triggers and non-prescription options, fuels OTC products' growth.

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Product Positioning and Market Dynamics

1. Consumer Preferences and Demand Drivers

Consumer trust in established OTC brands like EXCEDRIN remains high, driven by historical safety profiles, perceived efficacy, and ease of access. Nonetheless, there is growing demand for natural, non-pharmacologic alternatives, and products with fewer potential side effects, which challenge traditional formulations.

2. Regulatory Environment

Regulatory authorities, primarily the U.S. Food and Drug Administration (FDA), impose strict guidelines on OTC analgesics. Recent concerns over safety, especially regarding aspirin use in children and risks of Reye’s syndrome, have prompted regulatory reviews and labeling updates. The agency’s emphasis on clear labeling and risk communication influences product formulations and marketing.

3. Competitive Landscape

EXCEDRIN faces competition from multiple fronts:

• Prescription migraine medications (e.g., triptans, CGRP inhibitors), which offer targeted relief but at higher costs.
• Other OTC products such as Advil (ibuprofen), Tylenol (acetaminophen alone), and botanicals.
• Emerging digital health solutions and migraine tracking apps that influence consumer behavior.

These dynamics compel ongoing product development and strategic marketing to sustain market share.

4. Market Penetration and Consumer Reach

EXCEDRIN leverages extensive retail distribution, including drugstores, supermarkets, and online platforms. Digital marketing and social media campaigns have expanded its consumer outreach, especially among younger demographics seeking quick relief solutions.

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Financial Trajectory and Market Performance

1. Revenue Trends

Historically, EXCEDRIN's parent company has reported stable revenue streams from this flagship OTC product category. Although exact financials for EXCEDRIN are not publicly disclosed separately, estimates place OTC analgesic revenues at approximately USD 650 million annually within North America alone [3].

Product renewal efforts, including reformulations toward safer profiles and targeted marketing campaigns, sustain revenue streams amid competitive pressure.

2. Impact of New Regulations and Economic Factors

Stringent regulations and rising raw material costs influence profit margins. Price elasticity plays a significant role; OTC analgesics like EXCEDRIN benefit from consumer loyalty but face margin compression as competitors undercut prices.

3. Market Expansion Opportunities

Emerging markets in Asia-Pacific and Latin America exhibit significant potential, given increasing urbanization, westernization of healthcare practices, and healthcare infrastructure development. Strategic expansion here is poised to enhance revenues substantially over the next decade.

4. Digital and Innovation Strategies

Investments in digital health integration, such as mobile apps for migraine management and telemedicine services, create new revenue streams and strengthen consumer engagement. Additionally, reformulating products to include more natural or safer ingredients could align with evolving consumer preferences, capturing new market segments.

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Future Outlook and Strategic Considerations

Growth Drivers

• Rising prevalence of migraines worldwide.
• Growing preference for OTC products among healthcare-conscious consumers.
• Regulatory pathways favoring innovative formulations with improved safety profiles.
• Digital health integration and personalized medicine applications.

Potential Challenges

• Regulatory restrictions regarding ingredient safety.
• Competition from prescription alternatives and natural remedies.
• Price competition impacting margins.
• Changing consumer perceptions toward OTC analgesics.

Forecasted Financial Trajectory

Analysts project a moderate but steady growth trajectory for EXCEDRIN's market segment, aligning with industry CAGR expectations (~4-5%). A shift toward natural formulations and digital integration could augment revenue growth rates to approximately 6-7% annually over the next 3-5 years if strategic efforts succeed.

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Key Takeaways

• The OTC migraine relief market, with EXCEDRIN as a prominent player, remains resilient amid regulatory and competitive pressures.
• Consumer preferences are increasingly skewed toward safer, natural, and personalized remedies, prompting product reformulation and innovation.
• Digital health initiatives present valuable avenues for expanding market reach and boosting consumer engagement.
• Market expansion opportunities, especially in emerging economies, stand to significantly improve revenue streams over the long term.
• Regulatory developments will significantly influence the product's formulation, marketing, and financial performance.

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FAQs

1. How does EXCEDRIN maintain its competitive edge in the OTC migraine market?
By leveraging its established brand recognition, effective marketing strategies, and potential reformulation efforts aligning with safety and consumer preferences. Its availability across retail channels further bolsters market presence.

2. What regulatory changes could impact EXCEDRIN’s market performance?
Enhanced guidelines around aspirin and acetaminophen safety, advertising restrictions, and ingredient labeling could necessitate reformulations and alter marketing strategies.

3. Are there upcoming innovations that could influence EXCEDRIN’s sales?
Yes, integrating digital health tools, offering natural ingredient variants, or developing combination products for personalized migraine management may drive future growth.

4. Which geographic markets are most promising for expansion?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa present significant growth opportunities due to rising healthcare awareness and improved distribution channels.

5. How do consumer trends impact EXCEDRIN’s future?
Growing demand for natural, safe, and conveniently accessible pain relief options encourages product innovation and marketing adjustments to appeal to health-conscious demographic groups.

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References

[1] Global Burden of Disease Study 2019. The Lancet. 2022.
[2] MarketsandMarkets. “Headache and Migraines Market,” 2022.
[3] Statista. “Over-the-counter analgesics revenue,” 2023.