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 Inc, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, 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, Strides Pharma, Am Therap, Amneal Pharms Ny, Aurolife Pharma Llc, Duramed Pharms Barr, Elite Labs Inc, Everylife, Fosun Pharma, Halsey, Kv Pharm, Lederle, Mikart, Mutual Pharm, Nostrum Labs Inc, Puracap Pharm, Purepac Pharm, Rhodes Pharms, Roxane, Specgx Llc, Superpharm, Usl Pharma, Valeant Pharm Intl, Vitarine, Warner Chilcott, Watson Labs, Watson Labs Florida, Wes Pharma Inc, Whiteworth Town Plsn, Cent Pharms, Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, L Perrigo Co, Gavis Pharms, Larken Labs Inc, Wraser Pharms Llc, Boca Pharma Llc, and West-ward Pharm Corp. and is included in one hundred and forty 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 2021 were $4mm indicating the motivation for generic entry (peak sales were $30mm in 2005).

There have been fourteen 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:	69
NDAs:	140
Finished Product Suppliers / Packagers:	97
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	1,308
Patent Applications:	4,207
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
University Hospital "Sestre Milosrdnice"	N/A
Jessyka Lighthall	Phase 3
Jiangsu HengRui Medicine Co., Ltd.	Phase 1

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.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Halsey	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	083872-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Roxane	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	089513-001	Apr 25, 1989		DISCN	No	No
Pai Holdings	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	SOLUTION;ORAL	040119-001	Apr 26, 1996		DISCN	No	No
Sun Pharm Inds Ltd	ACETAMINOPHEN	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	090205-001	Nov 18, 2009		DISCN	No	No
Mikart	ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE	acetaminophen; caffeine; dihydrocodeine bitartrate	TABLET;ORAL	040316-001	Apr 28, 1999		DISCN	No	No
Nostrum Labs Inc	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	088629-002	Mar 6, 1985		DISCN	No	No
Sun Pharm Inds Ltd	ACETAMINOPHEN AND CODEINE PHOSPHATE	acetaminophen; codeine phosphate	TABLET;ORAL	087083-001	Approved Prior to Jan 1, 1982	AA	RX	No	No

International Patents for ACETAMINOPHEN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	2626068
Spain	2415354
World Intellectual Property Organization (WIPO)	2010121762
Brazil	PI1011630	paracetamol para a administração parenteral
European Patent Office	2243477	Paracétamol destiné à l'administration parentérale (Paracetamol for parenteral application)
European Patent Office	2421522	PARACÉTAMOL DESTINÉ À L'ADMINISTRATION PARENTÉRALE (PARACETAMOL FOR PARENTERAL ADMINISTRATION)
Portugal	2421522

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.