Acetaminophen; ibuprofen - Generic Drug Details

What are the generic drug sources for acetaminophen; ibuprofen and what is the scope of patent protection?

Acetaminophen; ibuprofen is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd, Bionpharma, Dr Reddys, Glenmark Pharms Ltd, Granules, L Perrigo Co, Marksans Pharma, Haleon Us Holdings, Aft Pharms Us, and Hikma, and is included in ten NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acetaminophen; ibuprofen has sixty-three patent family members in thirty-three countries.

Thirty-eight suppliers are listed for this compound.

Summary for acetaminophen; ibuprofen

International Patents:	63
US Patents:	9
Tradenames:	4
Applicants:	10
NDAs:	10
Finished Product Suppliers / Packagers:	38
Clinical Trials:	243
DailyMed Link:	acetaminophen; ibuprofen at DailyMed

Recent Clinical Trials for acetaminophen; ibuprofen

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

Sponsor	Phase
Cairo University	Phase 4
Jessyka Lighthall	Phase 3
Rutgers, The State University of New Jersey	Phase 4

See all acetaminophen; ibuprofen clinical trials

Pharmacology for acetaminophen; ibuprofen

Drug Class	Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for acetaminophen; ibuprofen

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

G02CC	Antiinflammatory products for vaginal administration
G02C	OTHER GYNECOLOGICALS
G02	OTHER GYNECOLOGICALS
G	Genito-urinary system and sex hormones

M01AE	Propionic acid derivatives
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

R02AX	Other throat preparations
R02A	THROAT PREPARATIONS
R02	THROAT PREPARATIONS
R	Respiratory system

Paragraph IV (Patent) Challenges for ACETAMINOPHEN; IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADVIL DUAL ACTION WITH ACETAMINOPHEN	Tablets	acetaminophen; ibuprofen	125 mg/250 mg	211733	2	2024-03-28

US Patents and Regulatory Information for acetaminophen; ibuprofen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Haleon Us Holdings	ADVIL DUAL ACTION WITH ACETAMINOPHEN	acetaminophen; ibuprofen	TABLET;ORAL	211733-001	Feb 28, 2020		OTC	Yes	Yes			Y
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes
Dr Reddys	ACETAMINOPHEN AND IBUPROFEN	acetaminophen; ibuprofen	TABLET;ORAL	218247-001	Aug 23, 2024		OTC	No	No
Aft Pharms Us	COMBOGESIC	acetaminophen; ibuprofen	TABLET;ORAL	209471-001	Mar 1, 2023		RX	Yes	Yes			Y

International Patents for acetaminophen; ibuprofen

Country	Patent Number	Title	Estimated Expiration
China	101022789	A combination composition
Australia	2020301401	Novel ibuprofen and acetaminophen composition
Mexico	2007000117	UNA COMPOSICION DE COMBINACION. (A COMBINATION COMPOSITION.)
Mexico	2021010338	COMPOSICION FARMACEUTICA QUE CONTIENE ACETOMINOFENO E IBUPROFENO. (PHARMACEUTICAL COMPOSITION CONTAINING ACETOMINOPHEN AND IBUPROFEN.)

Supplementary Protection Certificates for acetaminophen; ibuprofen

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania		PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726

Acetaminophen; ibuprofen Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen and Ibuprofen

Introduction to Acetaminophen and Ibuprofen

Acetaminophen and ibuprofen are two of the most widely used over-the-counter (OTC) pain relievers globally. These drugs play crucial roles in managing various types of pain and fever, and their markets are influenced by several key factors.

Acetaminophen Market Dynamics

Current Market Valuation

The global acetaminophen market was valued at USD 9.8 billion in 2022 and is projected to expand to USD 15.2 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 4.2% during the forecast period[2][3][5].

Key Market Drivers

• Increasing Chronic Illnesses: The rise in chronic illnesses such as cancer, chronic pulmonary obstructive disease (COPD), and other conditions drives the demand for acetaminophen. This is particularly evident in the growing need for pain management in cancer patients[3].
• Opioid Tolerance: The increasing use of medications to address opioid tolerance and the overtreatment of pain also fuels the demand for acetaminophen. Combining acetaminophen with opioids can enhance pain management without increasing side effects[3].
• Geriatric Population: The growing geriatric population, especially in countries like China, where life expectancy has increased significantly, contributes to the market growth. By 2040, it is estimated that 28% of the Chinese population will be 60 years or older[3].

Market Segmentation

• Oral Administration: The oral route of administration dominates the acetaminophen market, accounting for approximately 92.4% of the market share in 2022. This preference underscores the efficacy and convenience of oral consumption[2][3].
• Geographical Distribution: North America holds a significant share of the market, driven by a robust healthcare infrastructure and investments in research and development. The Asia-Pacific region, particularly China and India, is also expected to exhibit substantial growth due to increasing healthcare expenditures and a growing geriatric population[3][5].

Ibuprofen Market Dynamics

Current Market Valuation

The global ibuprofen market was valued at USD 1.43 billion in 2023 and is expected to reach USD 1.76 billion by 2032, growing at a CAGR of 2.44% during the forecast period[4].

Key Market Drivers

• Rising Chronic Diseases: The increasing incidence of chronic diseases such as rheumatoid arthritis, osteoarthritis, and cardiovascular diseases drives the demand for ibuprofen. For instance, rheumatoid arthritis affects approximately 1% of the population in India, impacting around 1 million people[1][4].
• Urbanization and Healthcare Spending: Rising urbanization and increased healthcare spending, particularly in the Asia-Pacific region, contribute to the market growth. The region's cost-efficient manufacturing of pharmaceuticals also supports the ibuprofen market[4].
• Consumer Awareness: Growing consumer awareness about over-the-counter (OTC) medications and the trend toward self-medication for minor ailments further drive the demand for ibuprofen[4].

Market Segmentation

• Geographical Distribution: The Asia-Pacific region is the largest market shareholder for ibuprofen, driven by low production costs in countries like China and India. North America is expected to be the fastest-growing market due to increasing healthcare needs and consumer awareness[4].

Financial Trajectory

Acetaminophen Financial Outlook

• The acetaminophen market is expected to grow from USD 9.8 billion in 2022 to USD 15.2 billion by 2033, with a CAGR of 4.2%. This growth is driven by the increasing demand for pain management solutions and the expanding geriatric population[2][3][5].

Ibuprofen Financial Outlook

• The ibuprofen market is projected to grow from USD 1.43 billion in 2023 to USD 1.76 billion by 2032, with a CAGR of 2.44%. This growth is fueled by the rising incidence of chronic diseases and increased healthcare spending, particularly in the Asia-Pacific region[4].

Regional Insights

Acetaminophen

• North America: Expected to account for the largest revenue share, driven by a robust healthcare infrastructure and significant investments in R&D[5].
• Asia-Pacific: Projected to dominate over 32% of the revenue share by 2037, driven by increasing population, general health issues, and government campaigns to enhance health awareness[5].

Ibuprofen

• Asia-Pacific: The largest market shareholder, driven by cost-efficient manufacturing and rising healthcare expenditures in countries like China and India[4].
• North America: Expected to be the fastest-growing market, driven by increasing healthcare needs and consumer awareness about OTC medications[4].

Challenges and Opportunities

Challenges

• Competition: Both markets face stiff competition from generic medications and other pain-relieving drugs. In the acetaminophen market, especially in China, the competition from various manufacturers is significant[3][5].
• Regulatory Frameworks: Changes in regulatory frameworks and safety guidelines can impact the production and distribution of these drugs.

Opportunities

• Emerging Markets: The growing demand in emerging economies, particularly in the Asia-Pacific region, presents significant opportunities for both acetaminophen and ibuprofen markets.
• Combination Therapies: The potential for combining these drugs with other pain-relieving medications to enhance efficacy without increasing side effects offers a promising avenue for growth[3].

Key Takeaways

• The acetaminophen market is expected to grow significantly, driven by the need for pain management in chronic illnesses and the growing geriatric population.
• The ibuprofen market is also poised for growth, fueled by the increasing incidence of chronic diseases and rising healthcare spending.
• Both markets are heavily influenced by regional dynamics, with the Asia-Pacific region playing a crucial role in their growth.
• The preference for oral administration and the trend toward self-medication are key drivers for both markets.

FAQs

Q: What is the projected market size of the acetaminophen market by 2033?

A: The acetaminophen market is expected to reach USD 15.2 billion by 2033, growing at a CAGR of 4.2% from 2022 to 2033[2][3].

Q: What are the main drivers of the ibuprofen market?

A: The main drivers include the rising incidence of chronic diseases, increasing healthcare spending, and growing consumer awareness about OTC medications[4].

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

A: The Asia-Pacific region is projected to dominate over 32% of the revenue share by 2037, driven by increasing population and general health issues[5].

Q: How does the geriatric population impact the acetaminophen market?

A: The growing geriatric population, especially in countries like China, significantly contributes to the market growth due to the increasing need for pain management solutions[3].

Q: What is the CAGR of the ibuprofen market from 2024 to 2032?

A: The ibuprofen market is expected to grow at a CAGR of 2.44% from 2024 to 2032[4].

Sources

1. Grand View Research - Ibuprofen API Market Size, Share & Growth Report, 2030
2. PharmiWeb - Acetaminophen Market Skyrockets to a Whopping US$ 15.2 Billion Valuation by 2033
3. Future Market Insights - Acetaminophen Market Size, Share, Trends & Outlook - 2033
4. Straits Research - Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report
5. Research Nester - Acetaminophen Market Size & Share, Growth Trends 2037