TYLENOL Drug Patent Profile

Which patents cover Tylenol, and what generic alternatives are available?

Tylenol is a drug marketed by J And J Consumer Inc, Kenvue Brands, Ortho Mcneil Pharm, and Janssen Pharms. and is included in seven NDAs.

The generic ingredient in TYLENOL is acetaminophen; codeine phosphate. There are sixty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; codeine phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tylenol

A generic version of TYLENOL was approved as acetaminophen; codeine phosphate by WES PHARMA INC on June 27^th, 2019.

Summary for TYLENOL

US Patents:	0
Applicants:	4
NDAs:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	179
Clinical Trials:	333
Patent Applications:	3,453
Drug Sales Revenues:	Drug sales revenues for TYLENOL
DailyMed Link:	TYLENOL at DailyMed

See drug sales revenues for TYLENOL

Recent Clinical Trials for TYLENOL

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

Sponsor	Phase
University of Miami	Phase 2
Mayo Clinic	Phase 4
Hamilton Health Sciences Corporation	Phase 3

See all TYLENOL clinical trials

US Patents and Regulatory Information for TYLENOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
J And J Consumer Inc	TYLENOL	acetaminophen	SUPPOSITORY;RECTAL	017756-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-002	Jan 11, 2001		OTC	Yes	Yes
Ortho Mcneil Pharm	TYLENOL W/ CODEINE	acetaminophen; codeine phosphate	TABLET;ORAL	085056-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Ortho Mcneil Pharm	TYLENOL W/ CODEINE	acetaminophen; codeine phosphate	TABLET;ORAL	085056-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Ortho Mcneil Pharm	TYLENOL W/ CODEINE NO. 3	acetaminophen; codeine phosphate	CAPSULE;ORAL	087422-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for TYLENOL

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
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994
Kenvue Brands	TYLENOL	acetaminophen	TABLET, EXTENDED RELEASE;ORAL	019872-001	Jun 8, 1994

International Patents for TYLENOL

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

Country	Patent Number	Title	Estimated Expiration
Australia	2001288
Greece	880100491
Ireland	62831	Orally sustained-release acetaminophen formulation and process to obtain it
Ireland	882286
Japan	S6440424	DELAY RELEASE TYPE ACETAMINOPHEN COMPOSITION FOR ORAL ADMINISTRATION AND MANUFACTURE

Tylenol (Acetaminophen) Market Dynamics and Financial Trajectory

Introduction

Tylenol, commonly known as acetaminophen, is a widely used over-the-counter (OTC) and prescription medication for pain relief and fever reduction. The global acetaminophen market is experiencing significant growth, driven by various factors. Here, we delve into the market dynamics and financial trajectory of Tylenol.

Current Market Valuation

As of 2022, the global acetaminophen market is valued at approximately $9.8 billion. This valuation underscores the drug's widespread use and acceptance in the healthcare sector[1][4].

Growth Projections

The acetaminophen market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 4.2% from 2023 to 2033. By 2033, the market is projected to reach a valuation of $15.2 billion. This growth is indicative of the drug's enduring importance in pain management and fever relief[1][4].

Market Dynamics

Oral Administration Dominance

The oral route of administration is the most prevalent, accounting for about 92.4% of the market share in 2022. This dominance highlights the preference and efficacy of oral acetaminophen consumption, which is a key driver of the market's growth[1][4].

Increasing Demand for Pain Management

The demand for acetaminophen is driven by the rising number of people with chronic illnesses such as cancer and chronic obstructive pulmonary disease (COPD). Additionally, the need for post-operative pain management and the growing awareness of opioid tolerance are significant factors contributing to the market's expansion[4].

Opioid Tolerance and Safety

As concerns about opioid addiction and side effects grow, acetaminophen emerges as a safer alternative. The commercialization of opioid-tolerant pharmaceuticals, which often include acetaminophen, is expected to further boost the market. Studies have shown that combining acetaminophen with opioids can enhance pain management without increasing side effects[4].

Regional Market Analysis

United States

The U.S. holds a significant share of the global acetaminophen market, largely due to a high prevalence of chronic illnesses and a strong healthcare infrastructure. The U.S. market is expected to continue its growth trajectory, driven by the increasing need for effective pain management solutions[4].

China

China is set to exhibit substantial growth in the acetaminophen market, with a CAGR of nearly 5.3% during the forecast period. This growth is attributed to the increasing life expectancy and the subsequent rise in non-communicable diseases among the Chinese population. By 2040, it is predicted that 28% of the Chinese population will be 60 years or older, further driving the demand for pain management medications[4].

India

India holds approximately 45.5% of the South Asia market share in 2022 and is expected to display lucrative growth during the forecast period. The growing healthcare needs and increasing awareness of pain management in India are key factors driving this growth[4].

Key Market Players

The acetaminophen market is characterized by the presence of several major pharmaceutical companies, including Pfizer Inc., Sanofi, Janssen Pharmaceuticals, Bayer AG, GlaxoSmithKline plc, and others. These companies play a crucial role in driving innovation, production, and distribution of acetaminophen products globally[4].

Financial Performance of Key Players

Companies like Johnson & Johnson, which is involved in the production and distribution of various pharmaceuticals, including pain management drugs, have shown mixed financial results. For instance, Johnson & Johnson reported a 1.3% increase in full-year sales in 2022, despite challenges such as unfavorable foreign exchange and reduced COVID-19 vaccine sales. The operational growth excluding COVID-19 vaccine sales was 6.1%, indicating the company's resilience in the pharmaceutical sector[2].

Future Prospects

Addressing Global Health Challenges

The acetaminophen market is not just a financial entity but a critical component in addressing global health challenges. As the market grows, it positions itself as a cornerstone in pain management and fever relief, catering to diverse medical needs worldwide[1].

Innovation and Efficacy

The future of the acetaminophen market is tied to innovation and efficacy. With ongoing research and development, the market is expected to see new formulations and delivery methods that enhance the drug's effectiveness and safety profile. This innovation will be crucial in sustaining the market's growth trajectory[1][4].

Key Takeaways

• The global acetaminophen market is valued at $9.8 billion as of 2022 and is projected to reach $15.2 billion by 2033.
• The oral route of administration dominates the market with a 92.4% share.
• Increasing demand for pain management, especially in chronic illnesses, drives the market.
• The market is expected to grow at a CAGR of 4.2% from 2023 to 2033.
• Regional markets, particularly in the U.S., China, and India, are expected to show significant growth.
• Major pharmaceutical companies are key players in driving the market forward.

FAQs

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

A: As of 2022, the global acetaminophen market is valued at approximately $9.8 billion[1][4].

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

A: The acetaminophen market is anticipated to grow at a CAGR of 4.2% from 2023 to 2033[1][4].

Q: Which route of administration dominates the acetaminophen market?

A: The oral route of administration accounts for about 92.4% of the market share[1][4].

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

A: The main drivers include the increasing number of people with chronic illnesses, post-operative pain management needs, and the growing awareness of opioid tolerance[4].

Q: Which regions are expected to show significant growth in the acetaminophen market?

A: The U.S., China, and India are expected to exhibit substantial growth during the forecast period[4].

Sources

1. PharmiWeb: Acetaminophen Market Skyrockets to a Whopping US$ 15.2 Billion Valuation by 2033.
2. Johnson & Johnson: Johnson & Johnson Reports Q4 and Full-Year 2022 Results.
3. MarketResearch.biz: Acetaminophen Paracetamol Market Size, and Forecast 2024.
4. Future Market Insights: Acetaminophen Market Size, Share, Trends & Outlook - 2033.
5. Johnson & Johnson: Johnson & Johnson Reports Q2 2023 Results.