ACETAMINOPHEN Drug Patent Profile

Which patents cover Acetaminophen, and when can generic versions of Acetaminophen launch?

Acetaminophen is a drug marketed by Rising, Aspiro, B Braun Medical, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Inforlife, Mylan, Sandoz, Wockhardt Bio Ag, Zydus Pharms, Able, Acino Prods, Perrigo New York, Taro, Aurobindo Pharma, Granules, Heritage Pharma, Marksans Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Teva, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Pharmobedient, Strides Pharma, Am Therap, Amneal Pharms Ny, Ani Pharms, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Hibrow Hlthcare, Kv Pharm, Lederle, Mikart, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Specgx Llc, Strides Pharma Intl, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Whiteworth Town Plsn, Cent Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, L Perrigo Co, Gavis Pharms, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp. and is included in one hundred and forty-two NDAs. There is one patent protecting this drug.

This drug has seventeen patent family members in twelve countries.

The generic ingredient in ACETAMINOPHEN is acetaminophen; caffeine; dihydrocodeine bitartrate. There are sixty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the acetaminophen; caffeine; dihydrocodeine bitartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Acetaminophen

Annual sales in 2022 were $10mm indicating the motivation for generic entry (peak sales were $30mm in 2005).

There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ACETAMINOPHEN

International Patents:	17
US Patents:	1
Applicants:	71
NDAs:	142
Finished Product Suppliers / Packagers:	94
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,419
Patent Applications:	4,009
Drug Prices:	Drug price information for ACETAMINOPHEN
Drug Sales Revenues:	Drug sales revenues for ACETAMINOPHEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACETAMINOPHEN
What excipients (inactive ingredients) are in ACETAMINOPHEN?	ACETAMINOPHEN excipients list
DailyMed Link:	ACETAMINOPHEN at DailyMed

See drug prices for ACETAMINOPHEN

See drug sales revenues for ACETAMINOPHEN

Recent Clinical Trials for ACETAMINOPHEN

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

Sponsor	Phase
AFT Pharmaceuticals, Ltd.	PHASE3
Stanford University	PHASE4
Wake Forest University Health Sciences	PHASE3

See all ACETAMINOPHEN clinical trials

Medical Subject Heading (MeSH) Categories for ACETAMINOPHEN

Analgesics, Non-Narcotic

Antipyretics

Paragraph IV (Patent) Challenges for ACETAMINOPHEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OFIRMEV	Injection	acetaminophen	650 mg/65 mL (10 mg/mL)	022450	1	2024-07-31
OFIRMEV	Injection	acetaminophen	1000 mg/100 mL (10 mg/mL)	022450	1	2011-04-07

US Patents and Regulatory Information for ACETAMINOPHEN

ACETAMINOPHEN is protected by one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Elite Labs Inc	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	212418-002	Sep 10, 2019	AA	RX	No	No
Rhodes Pharms	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	089673-001	Feb 10, 1988		DISCN	No	No
Chartwell Molecular	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	091238-001	Nov 10, 2011		DISCN	No	No

International Patents for ACETAMINOPHEN

See the table below for patents covering ACETAMINOPHEN around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2010238854
Japan	2012524738
Denmark	2421522

Market Dynamics and Financial Trajectory for Acetaminophen

Last updated: November 19, 2025

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Introduction

Acetaminophen, known internationally as paracetamol, remains one of the most widely used over-the-counter (OTC) analgesic and antipyretic medications. Its affordability, efficacy, and safety profile contribute to sustained demand across global markets. This analysis examines the current market landscape, key drivers and challenges, competitive dynamics, and financial forecasts shaping the future trajectory of acetaminophen.

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Market Overview

Globally, the acetaminophen market is characterized by steady growth driven by rising healthcare awareness and expanding OTC medication consumption. The compound is incorporated into numerous formulations ranging from standalone tablets to combination drugs for pain management and fever reduction. The product’s accessibility across developed and emerging markets affirms its dominant position.

According to recent industry reports, the global acetaminophen market was valued at approximately USD 2.2 billion in 2022, with projections reaching over USD 3.0 billion by 2030. The compound’s widespread use in consumer health products, including pediatric formulations, underscores its pivotal role in pain and fever management.

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Market Drivers

1. Growing Global Disease Burden and Consumer Demand

Increasing prevalence of chronic pain, influenza, viral infections, and related conditions sustains demand for acetaminophen. The World Health Organization (WHO) emphasizes its role in pain control and fever reduction, especially in resource-constrained settings, fueling sustained consumption [1].

2. Preference for Over-the-counter Medications

Regulatory easing in various jurisdictions enhances accessibility to OTC drugs, with acetaminophen positioned as a first-line analgesic. Consumers favor its perceived safety profile and cost-effectiveness, bolstering sales volumes.

3. Expanding Pharmaceutical and Consumer Product Portfolios

Manufacturers leverage acetaminophen as a core ingredient in combination drugs, including pediatric formulations, cold and flu remedies, and multi-symptom products. This diversification fosters incremental revenue streams.

4. Market Penetration in Emerging Economies

Emerging markets, driven by improved healthcare infrastructure and rising health literacy, exhibit robust growth in OTC medication use. Companies investing in regional manufacturing facilities capitalize on local demand.

5. Regulatory Approvals and Product Innovation

The consistent approval of new formulations and delivery mechanisms (e.g., liquid gels, effervescent tablets, and fast-absorption variants) enhances market appeal and consumer compliance.

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Market Challenges

1. Safety Concerns and Regulatory Restrictions

Hepatotoxicity risks associated with high doses of acetaminophen trigger regulatory scrutiny. Countries like the U.S. (via the FDA) have imposed dosage caps and labeling requirements, which can influence market dynamics [2].

2. Rising Generic Competition

The non-patented nature of acetaminophen leads to fierce price competition among generic manufacturers, putting downward pressure on margins.

3. Alternative Analgesics and Pharmacovigilance Data

Emergence of alternative pain relievers (NSAIDs, opioids) where permissible, and heightened pharmacovigilance, may impact market share. Negative perceptions following safety alerts can also dampen demand.

4. Supply Chain Disruptions

Raw material shortages, geopolitical tensions, and manufacturing constraints, as observed during the COVID-19 pandemic, potentially limit supply and affect pricing strategies.

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Competitive Landscape

Industry leaders such as Johnson & Johnson, Perrigo, and GlaxoSmithKline hold significant market share, largely through robust distribution networks and diverse product offerings. Several regional players also command substantial sales within specific geographical niches. The market's commoditized nature makes price competition and operational efficiency critical success factors.

Innovative formulations and strategic partnerships are prevalent trends. For example, companies are investing in sustained-release variants and combination therapies that meet evolving consumer needs. Regulatory compliance and quality assurance remain vital to maintain brand loyalty and secure market access.

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Financial Trajectory and Future Outlook

Forecasts indicate a compound annual growth rate (CAGR) between 4-6% over the next decade, driven primarily by demand in emerging markets and new product development. Key financial factors influencing this trajectory include:

• Pricing Strategies: Margin erosion due to generic competition necessitates cost control and value-added offerings.
• Manufacturing Capabilities: Investment in scalable, cost-efficient production facilities supports margin preservation and market expansion.
• Regulatory Navigation: Continuous compliance and proactive engagement with health authorities mitigate risks of market restrictions.
• Research & Development: While acetaminophen’s generic nature limits patent-driven innovations, incremental improvements in formulations and delivery systems sustain interest.

The ongoing global healthcare focus on accessible, safe, and effective analgesics positions acetaminophen as a resilient staple within the pharmaceutical landscape. With endemic disease burdens and expanding consumer markets, revenues are expected to grow steadily, albeit with margin pressures from intensifying competition.

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Regional Market Insights

North America: The largest market segment, driven by high OTC consumption and robust healthcare infrastructure. Regulatory vigilance on hepatotoxicity has led to clearer dosing guidelines, supporting consumer confidence.

Europe: Mature market with incremental growth. Stringent regulations necessitate innovation and quality assurance.

Asia-Pacific: Fastest-growing sector owing to large population bases, rising disposable incomes, and expanding healthcare access, making it a primary focus for manufacturers.

Latin America and Africa: Emerging markets show significant potential, though growth is tempered by infrastructural challenges and regulatory diversity.

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Strategic Implications for Stakeholders

• Manufacturers should focus on cost-efficient production and innovative delivery options to differentiate their offerings. Engaging in geographic and demographic expansion can unlock new revenue streams.
• Investors should monitor regulatory developments and competitive pricing trends, particularly the impact of generics on profit margins.
• Regulators must balance access with safety, emphasizing clear labeling and dosage guidelines to sustain public trust.

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Key Takeaways

• The acetaminophen market demonstrates steady growth driven by global disease burden, OTC demand, and product diversification.
• Price competition among generics constrains margins, necessitating operational efficiencies and innovation.
• Safety concerns and regulatory oversight remain key industry considerations, influencing formulation and marketing strategies.
• Emerging markets present substantial growth opportunities, supported by increasing healthcare infrastructure and consumer health awareness.
• Long-term financial success hinges on strategic geographic expansion, regulatory compliance, and incremental product innovation.

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FAQs

1. Why is acetaminophen considered a safe analgesic option?
Because when used within recommended dosages, acetaminophen has a favorable safety profile, with a low risk of gastrointestinal irritation or cardiovascular effects common with NSAIDs. However, overdose risks, particularly hepatotoxicity, necessitate appropriate dosing and regulation.

2. How do regulatory bodies influence the acetaminophen market?
Regulators impact market dynamics through dosage regulations, labeling requirements, and safety warnings. These measures aim to minimize overdose risks, influence product formulations, and may impose restrictions that affect market size and growth.

3. What are the primary factors impacting acetaminophen’s pricing?
Market pricing is primarily driven by generic competition, raw material costs, regulatory compliance expenses, and regional market conditions.

4. Can innovation in formulations expand acetaminophen's market share?
Yes, formulations such as sustained-release, pediatric-friendly liquids, and combination products can cater to specific consumer needs, broadening market appeal and potentially commanding premium prices.

5. What is the outlook for acetaminophen in developing economies?
The outlook remains optimistic, as increased healthcare access, rising disposable incomes, and regulatory reforms drive OTC demand. Local manufacturing and partnerships further facilitate market penetration.

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References

[1] World Health Organization. (2021). Guidelines for the Management of Pain and Fever. WHO Press.
[2] U.S. Food and Drug Administration. (2014). Acetaminophen: Drug Safety Communication. FDA.gov.