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 Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, 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, Aurobindo Pharma Ltd, Haleon Us Holdings, Mikart, Scherer Labs, Zevra Therap, Forest Pharms, Mallinckrodt, Dr Reddys Labs Sa, Valeant, Dunhall, Larken Labs Inc, Alvogen, 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, Abhai Llc, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, Hikma Intl Pharms, Nostrum Labs Inc, 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, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Kv Pharm, Lederle, Mutual Pharm, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs Florida, Wes Pharma Inc, Whiteworth Town Plsn, Carnrick, Glaxosmithkline, Vangard, Janssen Pharms, Schering Plough, Cent Pharms, Ivax Pharms, Genus, Mallinckrodt Inc, Pharm Assoc, Tris Pharma Inc, Cypress Pharm Inc, Ucb Inc, Ascher, Actavis Labs Fl Inc, Amneal Pharms, Apil, Ascent Pharms Inc, Barr, Caraco, Endo Operations, Epic Pharma Llc, Novel Labs Inc, 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, Bristol Myers Squibb, 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, and Zydus Pharms Usa Inc, and is included in five hundred and twenty-eight NDAs. There are thirty-one 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. Ninety-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for acetaminophen

International Patents:	21
US Patents:	31
Tradenames:	108
Applicants:	159
NDAs:	528
Drug Master File Entries:	66
Finished Product Suppliers / Packagers:	97
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	1,308
Patent Applications:	7,116
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
University Hospital "Sestre Milosrdnice"	N/A
Jessyka Lighthall	Phase 3
Jiangsu HengRui Medicine Co., Ltd.	Phase 1

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
Fresenius Kabi Usa	ACETAMINOPHEN	acetaminophen	SOLUTION;INTRAVENOUS	204767-001	Oct 28, 2015		RX	No	No			Y
Mutual Pharm	PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN	acetaminophen; propoxyphene napsylate	TABLET;ORAL	070771-001	Mar 21, 1986		DISCN	No	No
Barr	OXYCODONE AND ACETAMINOPHEN	acetaminophen; oxycodone hydrochloride	TABLET;ORAL	087406-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for acetaminophen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Hosp	OFIRMEV	acetaminophen	SOLUTION;INTRAVENOUS	022450-001	Nov 2, 2010
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994
J And J Consumer Inc	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994

International Patents for acetaminophen

Country	Patent Number	Title	Estimated Expiration
Brazil	PI1011630	paracetamol para a administração parenteral
Japan	2012524738
European Patent Office	2243477	Paracétamol destiné à l'administration parentérale (Paracetamol for parenteral application)

Acetaminophen Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen

Introduction to Acetaminophen

Acetaminophen, commonly known as paracetamol, is a widely used analgesic and antipyretic drug. It is a cornerstone in pain management and fever relief, catering to a broad spectrum of medical needs. Here, we delve into the market dynamics and financial trajectory of acetaminophen, highlighting its current status, growth drivers, and future prospects.

Current Market Valuation

As of 2022, the global acetaminophen market was valued at approximately USD 9.8 billion. This valuation underscores the significant presence of acetaminophen in the global pharmaceutical landscape[1][4].

Growth Trajectory

The acetaminophen market is anticipated to experience robust growth, with a projected Compound Annual Growth Rate (CAGR) of 4.2% from 2023 to 2033. This growth is expected to drive the market valuation to USD 15.2 billion by 2033[1][4].

Market Dynamics: Oral Administration Dominance

One of the key dynamics in the acetaminophen market is the dominance of oral administration. As of 2022, oral routes of administration accounted for approximately 92.4% of the market share. This preference highlights the efficacy and convenience of oral consumption, which is a major driver of the market[1][4].

Geographical Market Share

The acetaminophen market is geographically diverse, with different regions contributing significantly to its growth.

• North America: This region is expected to account for a substantial share, driven by a robust healthcare infrastructure and significant investments in research and development (R&D). By 2037, North America is likely to hold around 37% of the revenue share[3].
• Asia Pacific: This region is projected to dominate with over 32% of the revenue share by 2037, driven by an increasing population, general health issues, and government campaigns to enhance health awareness and access to quality healthcare[3].

Growth Drivers

Several factors are driving the growth of the acetaminophen market:

• Increasing Chronic Illnesses: The rise in chronic illnesses such as cancer and chronic obstructive pulmonary disease (COPD) is increasing the demand for acetaminophen[4].
• Opioid Tolerance: The growing need to address opioid tolerance and the overtreatment of pain is another significant driver. Acetaminophen is seen as a safer alternative to opioids, reducing the risk of addiction and adverse effects[4].
• Palliative Care: Increasing awareness about palliative care in critically ill patients is boosting the adoption of analgesics like acetaminophen for pain management[5].

Price Trends and Fluctuations

The price of acetaminophen has experienced fluctuations due to various factors:

• Raw Material Costs: Changes in the prices of raw materials such as para-aminophenol and phenol have significantly impacted the production costs and, consequently, the market prices of acetaminophen. For instance, in the fourth quarter of 2023, lower raw material prices led to a decrease in acetaminophen prices[2].
• Global Economic Conditions: Economic downturns, such as recessions and inflation, have affected demand and pricing. In 2023, weak global economic conditions led to a downward trend in acetaminophen prices[2].
• Regulatory Changes: Initiatives by regulatory bodies, such as the National Pharmaceutical Pricing Authority (NPPA), have also influenced pricing. For example, a minor increase in the Maximum Retail Price of essential medicines, including acetaminophen, was announced in 2024[2].

Key Market Players

The acetaminophen market is dominated by several major pharmaceutical companies, including:

• Pfizer Inc.
• Sanofi
• Janssen Pharmaceuticals
• Bayer AG
• GlaxoSmithKline plc
• Bristol-Myers Squibb and Company
• Teva Pharmaceutical Industries Ltd
• Cardinal Health Inc.
• Perrigo Company
• Novartis AG
• Sun Pharmaceutical Industries Ltd
• Abbott
• Mallinckrodt Pharmaceuticals
• Procter & Gamble Company[4].

Acetaminophen API Market

The Active Pharmaceutical Ingredient (API) market for acetaminophen is also growing steadily. As of 2023, the global acetaminophen API market was valued at approximately USD 1,180.4 million and is expected to reach USD 1,648.2 million by 2033, growing at a CAGR of 3.4%[5].

Challenges and Opportunities

While the acetaminophen market presents several opportunities, it also faces challenges:

• Adverse Effects: Heavy usage of acetaminophen can lead to serious adverse effects and toxicity, which is a concern that needs to be addressed[5].
• Regulatory Battles: Legal battles between pharmaceutical companies and regulatory bodies over pricing and other issues can create market instability[2].

Future Prospects

The acetaminophen market is poised for significant growth, driven by increasing healthcare needs, the rise in chronic illnesses, and the need for safer pain management alternatives. As the market expands, it is expected to play a crucial role in addressing global healthcare challenges.

"Acetaminophen is not merely a financial figure; it represents a crucial player in addressing global healthcare challenges. As it forges ahead towards a projected valuation of US$ 15.2 billion by 2033, it positions itself as a cornerstone in pain management and fever relief, catering to diverse medical needs."[1]

Key Takeaways

• The global acetaminophen market is valued at USD 9.8 billion as of 2022 and is expected to reach USD 15.2 billion by 2033.
• Oral administration dominates the market, accounting for approximately 92.4% of the market share.
• North America and Asia Pacific are key regions driving the market growth.
• Increasing chronic illnesses and the need to address opioid tolerance are significant growth drivers.
• The acetaminophen API market is also growing, with a projected valuation of USD 1,648.2 million by 2033.

Frequently Asked Questions (FAQs)

Q1: What is the current valuation of the global acetaminophen market?

• The global acetaminophen market was valued at approximately USD 9.8 billion as of 2022[1][4].

Q2: What is the projected growth rate of the acetaminophen market from 2023 to 2033?

• The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 4.2% from 2023 to 2033[1][4].

Q3: Which region is expected to dominate the acetaminophen market by 2037?

• The Asia Pacific region is expected to dominate with over 32% of the revenue share by 2037[3].

Q4: What are the main drivers of demand for acetaminophen?

• The main drivers include the rise in chronic illnesses, the need to address opioid tolerance, and increasing awareness about palliative care[4][5].

Q5: What are the potential challenges facing the acetaminophen market?

• Challenges include adverse effects from heavy usage, regulatory battles, and fluctuations in raw material costs and global economic conditions[2][5].

Sources:

1. Future Market Insights: Acetaminophen Market Skyrockets to a Whopping US$ 15.2 Billion Valuation by 2033.
2. Procurement Resource: Acetaminophen Price Trend and Forecast.
3. Research Nester: Acetaminophen Market Size & Share, Growth Trends 2037.
4. Future Market Insights: Acetaminophen Market Size, Share, Trends & Outlook - 2033.
5. Future Market Insights: Acetaminophen API Market Share, Trends & Forecast 2033.