ACETAMINOPHEN - Generic Drug Details

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

Acetaminophen is the generic ingredient in one hundred and eight branded drugs marketed by Ortho Mcneil Pharm, Rising, Aspiro, B Braun Medical, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland, Hikma, Inforlife, Mylan, Sandoz, Wockhardt Bio Ag, Zydus Pharms, Mallinckrodt Hosp, Cosette, Able, Acino Prods, Perrigo New York, Taro, Polymedica, J And J Consumer Inc, Aurobindo Pharma, Granules, Heritage Pharma, Marksans Pharma, Ohm Labs, Perrigo, Sun Pharm Inds Ltd, Kenvue Brands, Aurobindo Pharma Ltd, Haleon Us Holdings, Mikart, Scherer Labs, Zevra Therap, Forest Pharms, Mallinckrodt, Dr Reddys Labs Sa, Valeant, Dunhall, Pharmobedient, Alvogen, Anda Repository, Halsey, Lgm Pharma, Ne Rx Pharma, Quagen, Senores Pharms, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Key Therap, Lannett Co Inc, Novast Labs, Nuvo Pharms Inc, Us Chem, Genus, Abhai Llc, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Strides Pharma Intl, Sun Pharm Industries, Vintage Pharms, Hikma Intl Pharms, Wraser Pharms Llc, Pharm Res Assoc, Leitner Pharms, Boca Pharma Llc, West-ward Pharm Corp, Novartis, Teva, Robins Ah, Solvay, Actavis Mid Atlantic, Chartwell, Chartwell Molecular, Dava Pharms Inc, Genus Lifesciences, Pai Holdings, Valeant Pharms Llc, Am Therap, Amneal Pharms Ny, Ani Pharms, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Hibrow Hlthcare, Kv Pharm, Lederle, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs Florida, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, Janssen Pharms, Schering Plough, Cent Pharms, Ivax Pharms, Mallinckrodt Inc, Pharm Assoc, Tris Pharma Inc, Wes Pharma Inc, Cypress Pharm Inc, Ucb Inc, Ascher, Actavis Labs Fl Inc, Amneal Pharms, Apil, Ascent Pharms Inc, Barr, Caraco, Epic Pharma Llc, Novel Labs Inc, Ph Health, Prinston Inc, Ranbaxy, Ranbaxy Labs Ltd, Sanaluz, Sun Pharm Inds Inc, Upsher Smith Labs, Vintage Pharms Llc, Abana, Abbott, Abbvie, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, L Perrigo Co, Aft Pharms Us, Actavis Elizabeth, Sankalp Lifecare, Bristol Myers Squibb, Endo Operations, Gavis Pharms, Sanofi Aventis Us, Aaipharma Llc, Xanodyne Pharm, Cornerstone, Ivax Sub Teva Pharms, Mirror Pharms, Mylan Pharms Inc, Wockhardt Ltd, Alkem Labs Ltd, Chartwell Rx, Graviti Pharms, Macleods Pharms Ltd, Micro Labs Ltd India, Mpp Pharma, and Zydus Pharms Usa Inc, and is included in five hundred and thirty NDAs. There are thirty-two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetaminophen has twenty-one patent family members in thirteen countries.

There are sixty-six drug master file entries for acetaminophen. One hundred suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ACETAMINOPHEN

International Patents:	21
US Patents:	32
Tradenames:	108
Applicants:	167
NDAs:	530
Drug Master File Entries:	66
Finished Product Suppliers / Packagers:	100
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,419
Patent Applications:	7,093
Drug Prices:	Drug price trends 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

Generic filers with tentative approvals for ACETAMINOPHEN

Applicant	Application No.	Strength	Dosage Form
		325MG; 7.5MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	CAPSULE;ORAL	040257-001	Aug 4, 1998		DISCN	No	No
Chartwell	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	207834-001	Aug 15, 2019		DISCN	No	No
Ascent Pharms Inc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	211487-004	Nov 7, 2018	AA	RX	No	No
Actavis Elizabeth	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	201447-001	Apr 12, 2013	AA	RX	No	No

Expired US Patents for ACETAMINOPHEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994	4,968,509
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010	6,028,222*PED
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994	5,004,613
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994	4,820,522

International Patents for ACETAMINOPHEN

Country	Patent Number	Title	Estimated Expiration
Australia	2010238854
Japan	2012524738
World Intellectual Property Organization (WIPO)	2010121762
Japan	2011503198

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.