ACETAMINOPHEN; ASPIRIN; CAFFEINE - Generic Drug Details

What are the generic sources for acetaminophen; aspirin; caffeine and what is the scope of freedom to operate?

Acetaminophen; aspirin; caffeine is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Granules, Perrigo, and Haleon Us Holdings, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Forty-three suppliers are listed for this compound.

Summary for ACETAMINOPHEN; ASPIRIN; CAFFEINE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	7
Patent Applications:	13
DailyMed Link:	ACETAMINOPHEN; ASPIRIN; CAFFEINE at DailyMed

Recent Clinical Trials for ACETAMINOPHEN; ASPIRIN; CAFFEINE

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

Sponsor	Phase
Ache Laboratorios Farmaceuticos S.A.	Phase 3
Bayer	Phase 2
BioHealthonomics Inc.	Phase 2

See all ACETAMINOPHEN; ASPIRIN; CAFFEINE clinical trials

Pharmacology for ACETAMINOPHEN; ASPIRIN; CAFFEINE

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

Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; ASPIRIN; CAFFEINE

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

N06BC	Xanthine derivatives
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for ACETAMINOPHEN; ASPIRIN; CAFFEINE

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
Aurobindo Pharma Ltd	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	acetaminophen; aspirin; caffeine	TABLET;ORAL	211695-001	Feb 2, 2022		OTC	No	No
Perrigo	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	acetaminophen; aspirin; caffeine	TABLET;ORAL	075794-001	Nov 26, 2001		OTC	No	No
Granules	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	acetaminophen; aspirin; caffeine	TABLET;ORAL	214039-001	Feb 23, 2021		OTC	No	No

Expired US Patents for ACETAMINOPHEN; ASPIRIN; CAFFEINE

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
Haleon Us Holdings	EXCEDRIN (MIGRAINE RELIEF)	acetaminophen; aspirin; caffeine	TABLET;ORAL	020802-001	Jan 14, 1998

ACETAMINOPHEN; ASPIRIN; CAFFEINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Acetaminophen; Aspirin; Caffeine

Introduction

The combination of acetaminophen, aspirin, and caffeine is a widely recognized and effective treatment for various types of headaches, including migraines and tension-type headaches. This article delves into the market dynamics and financial trajectory of this drug combination, highlighting its efficacy, market presence, and financial implications.

Efficacy and Clinical Significance

Pain Relief Efficacy

Studies, including those from Cochrane Review reports, have consistently shown that the addition of caffeine to acetaminophen or ibuprofen significantly enhances their analgesic efficacy. For instance, combining caffeine with ibuprofen or acetaminophen resulted in a higher proportion of participants achieving at least 50% pain relief over four to six hours[1].

FDA Recognition and Clinical Use

The FDA has recognized the combination of acetylsalicylic acid (250 mg), acetaminophen (250 mg), and caffeine (65 mg) as safe and effective for treating acute headaches, particularly migraines. This combination is also endorsed by the American Headache Society for its efficacy in episodic tension-type headaches[2][5].

Market Presence

Brand Recognition

One of the most well-known brands that combine these ingredients is Excedrin. Excedrin is available in various formulations, including Excedrin Migraine and Excedrin Extra Strength, which are widely used for treating migraine and tension-type headaches. Although Excedrin is no longer sold in Canada due to formulation differences, it remains a dominant player in the U.S. market[4].

Ownership and Transactions

The brand has undergone significant ownership changes. In 2005, Bristol-Myers Squibb sold its North American consumer medicine business, including Excedrin, to Novartis for $660 million. Later, in 2015, GlaxoSmithKline acquired majority ownership through a joint venture with Novartis[4].

Financial Trajectory

Revenue and Market Share

The over-the-counter (OTC) pain relief market is highly competitive, but the combination of acetaminophen, aspirin, and caffeine holds a significant market share due to its proven efficacy. Excedrin, as a leading brand, contributes substantially to the revenue of its parent companies. The financial performance of these companies is influenced by the consistent demand for effective headache treatments.

Pricing and Accessibility

The combination is generally priced competitively within the OTC market, making it accessible to a wide range of consumers. The affordability of this combination, coupled with its availability in various retail outlets and online platforms, contributes to its strong market position.

Regulatory and Safety Considerations

Safety Profile

The combination of acetaminophen, aspirin, and caffeine is well-tolerated, with a favorable safety profile. However, there are specific considerations for special populations, such as patients with renal or hepatic impairment, where dose adjustments may be necessary[2][5].

Regulatory Compliance

The FDA's recognition and the endorsement by the American Headache Society ensure that the product meets stringent regulatory standards. Compliance with these regulations is crucial for maintaining market presence and consumer trust.

Consumer Preferences and Trends

Increasing Demand for Effective Pain Relief

There is a growing demand for effective and safe pain relief options, driven by the increasing prevalence of headaches and other pain conditions. Consumers are more inclined towards products that offer rapid and sustained relief, making the acetaminophen, aspirin, and caffeine combination a preferred choice.

Health Awareness and Self-Care

The trend towards self-care and health awareness has led consumers to seek out products that are not only effective but also safe for long-term use. The combination of acetaminophen, aspirin, and caffeine, being safe during breastfeeding and for various patient groups, aligns well with these consumer preferences[2][5].

Competitive Landscape

Market Competitors

The OTC pain relief market is highly competitive, with various brands offering similar combinations. However, the established brand reputation of Excedrin and the proven efficacy of the acetaminophen, aspirin, and caffeine combination give it a competitive edge.

Innovation and Product Development

To maintain market share, companies are continually innovating and developing new formulations and delivery methods. For example, the availability of this combination in oral tablets and other forms ensures that it remains a viable option for consumers with different preferences.

Financial Projections

Revenue Growth

Given the consistent demand for effective headache treatments and the strong brand presence of Excedrin, revenue growth for this combination is expected to remain stable or increase slightly over the next few years.

Market Expansion

Expansion into new markets, particularly in regions where headache prevalence is high, could further boost revenue. Additionally, strategic marketing and educational campaigns can help increase consumer awareness and drive sales.

Key Takeaways

• The combination of acetaminophen, aspirin, and caffeine is highly effective for treating various types of headaches.
• This combination is recognized by the FDA and endorsed by the American Headache Society.
• Excedrin, a leading brand, has a significant market presence and contributes substantially to the revenue of its parent companies.
• The product's safety profile and regulatory compliance are crucial for its market position.
• Consumer trends towards effective and safe pain relief options continue to drive demand.

FAQs

Q1: What is the typical dosage of the acetaminophen, aspirin, and caffeine combination for migraine headaches?

The typical dosage is 2 tablets orally once every 24 hours as needed, with each tablet containing 250 mg of acetaminophen, 250 mg of aspirin, and 65 mg of caffeine[2][5].

Q2: Is the combination of acetaminophen, aspirin, and caffeine safe during breastfeeding?

Yes, all components of this combination are considered safe during breastfeeding and can be taken orally for acute migraine attacks[2][5].

Q3: How does caffeine enhance the analgesic efficacy of acetaminophen or ibuprofen?

Caffeine enhances the analgesic efficacy by increasing the proportion of participants achieving at least 50% pain relief over four to six hours. This is attributed to the synergistic effect of caffeine with these analgesics[1].

Q4: What are the potential adverse effects of habitual daily use of caffeine in this combination?

Habitual daily use of caffeine can lead to adverse effects such as daytime sleepiness, worsening sleep quality, osteopenia, and physical and emotional dependence[5].

Q5: Why is Excedrin no longer sold in Canada?

Excedrin is no longer sold in Canada due to differences in formulation, specifically the risk of renal papillary necrosis associated with the combination of acetaminophen and aspirin when taken in large doses chronically[4].

Sources

1. Wolters Kluwer: Adding Caffeine to OTC Pain Relievers Improves Analgesic Efficacy.
2. NCBI: Acetaminophen/Aspirin/Caffeine.
3. DrugBank: Acetaminophen: Uses, Interactions, Mechanism of Action.
4. Wikipedia: Excedrin (brand).
5. NCBI Bookshelf: Acetaminophen/Aspirin/Caffeine - StatPearls.