ACETAMINOPHEN; IBUPROFEN SODIUM - Generic Drug Details

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

Acetaminophen; ibuprofen sodium is the generic ingredient in one branded drug marketed by Hikma and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for ACETAMINOPHEN; IBUPROFEN SODIUM

International Patents:	65
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
DailyMed Link:	ACETAMINOPHEN; IBUPROFEN SODIUM at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ACETAMINOPHEN; IBUPROFEN SODIUM

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ACETAMINOPHEN; IBUPROFEN SODIUM

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

Sponsor	Phase
University of California, Los Angeles	Phase 4
Northwestern University	Phase 4
Nemours Children's Clinic	Early Phase 1

See all ACETAMINOPHEN; IBUPROFEN SODIUM clinical trials

Pharmacology for ACETAMINOPHEN; IBUPROFEN SODIUM

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

Anatomical Therapeutic Chemical (ATC) Classes for ACETAMINOPHEN; IBUPROFEN SODIUM

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

US Patents and Regulatory Information for ACETAMINOPHEN; IBUPROFEN SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	11,896,567
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	12,083,087
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	11,213,498		Y
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	11,446,266
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes	11,389,416		Y

International Patents for ACETAMINOPHEN; IBUPROFEN SODIUM

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3169307	FORMULATION AQUEUSE COMPRENANT DU PARACÉTAMOL ET DE L'IBUPROFÈNE (AQUEOUS FORMULATION COMPRISING PARACETAMOL AND IBUPROFEN)
Mexico	2013005113	UNA COMPOSICION COMBINADA. (A COMBINATION COMPOSITION.)
South Korea	20140025314	A COMBINATION COMPOSITION
Russian Federation	2015103107	КОМБИНИРОВАННАЯ КОМПОЗИЦИЯ
Eurasian Patent Organization	201790223	ВОДНЫЙ ПРЕПАРАТ, СОДЕРЖАЩИЙ ПАРАЦЕТАМОЛ И ИБУПРОФЕН
Brazil	112017001093	formulação aquosa compreendendo paracetamol e ibuprofeno

ACETAMINOPHEN; IBUPROFEN SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetaminophen and Ibuprofen Sodium

Market Overview

The global market for over-the-counter (OTC) analgesics, which includes acetaminophen and ibuprofen sodium, is experiencing significant growth driven by several key factors.

Growing Demand for Pain Relief

The increasing prevalence of chronic diseases and the rising geriatric population worldwide are major drivers of the OTC analgesics market. Chronic illnesses such as cancer, chronic pulmonary obstructive disease (COPD), and other conditions that require ongoing pain management are fueling the demand for acetaminophen and other analgesics[1][3].

Acetaminophen Market Dynamics

Market Size and Growth

The global acetaminophen market was valued at USD 9.8 billion in 2022 and is projected to expand at a CAGR of 4.2% to reach USD 15.2 billion by 2033. This growth is largely driven by the increasing use of medications to address opioid tolerance and the overtreatment of pain[3].

Regional Insights

North America and Europe dominate the acetaminophen market due to its superior efficacy and widespread availability. However, regions like China and India are also exhibiting robust growth. China, for instance, is expected to grow at a CAGR of nearly 5.3% during the forecast period, driven by an increasing geriatric population and the rising burden of non-communicable diseases[3].

Route of Administration

The oral route of administration is the most prevalent, accounting for approximately 92.4% of the market share in 2022. This is due to the non-invasive, practical, and economical nature of oral medication delivery[3].

Key Drivers

• Chronic Illnesses: The rise in chronic illnesses such as cancer and COPD is a significant driver.
• Opioid Tolerance: The need for alternatives to opioids due to tolerance and addiction issues is another key factor.
• Healthcare Expenditures: Increasing healthcare expenditures and the ease of access to affordable medications are also driving the market[3].

Ibuprofen Sodium Market Dynamics

Market Size and Growth

While the specific market size for ibuprofen sodium is not isolated, the broader OTC analgesics market, which includes ibuprofen, is valued at US$ 28.55 billion in 2022 and is projected to reach US$ 39.74 billion by 2030, growing at a CAGR of 4.84%[1].

Efficacy and Onset of Action

Ibuprofen sodium has been shown to have a faster onset of action and greater analgesic efficacy compared to acetaminophen. Studies have demonstrated that sodium ibuprofen provides quicker and more effective pain relief, especially in post-operative dental pain scenarios[2][4].

Safety Profile

The safety profile of ibuprofen sodium is generally favorable, with clinical trials and postmarketing data supporting its safety. However, like other NSAIDs, it carries risks such as gastrointestinal issues and cardiovascular effects, particularly when used in high doses or over extended periods[4].

Regulatory Approval

Ibuprofen sodium has received regulatory approval, with the FDA acknowledging its bioequivalence to existing ibuprofen products and approving it for OTC use. This approval has expanded its availability and accessibility to consumers[4].

Financial Trajectory

Acetaminophen

• Current Valuation: USD 9.8 billion in 2022.
• Projected Valuation: USD 15.2 billion by 2033.
• CAGR: 4.2% from 2023 to 2033[3].

Ibuprofen Sodium

• Part of Broader OTC Analgesics Market: Valued at US$ 28.55 billion in 2022.
• Projected Valuation: US$ 39.74 billion by 2030.
• CAGR: 4.84% from 2023 to 2030[1].

Regional Market Insights

North America

North America is expected to gain the highest share in the OTC analgesics market, driven by the increasing prevalence of chronic diseases and a growing geriatric population. The FDA's approval of new OTC drugs, such as Voltaren, has also contributed to this growth[1].

Europe and Asia Pacific

Europe and the Asia Pacific region are also witnessing robust growth. The Asia Pacific, particularly countries like China and India, is driven by rapid economic expansion and an increasing geriatric population[1][3].

Key Players and Market Share

Acetaminophen

Major players in the acetaminophen market include Pfizer Inc., Sanofi, Janssen Pharmaceuticals, Bayer AG, and GlaxoSmithKline plc. These companies dominate the market due to their extensive product portfolios and strong distribution networks[3].

Ibuprofen Sodium

Key players in the ibuprofen market include companies like Pfizer (Advil), Bayer AG, and others. These companies have a significant market share due to their well-established brands and continuous innovation in product formulations[4].

Challenges and Opportunities

Challenges

• Drug Tolerance and Addiction: One of the major challenges is the risk of drug tolerance, dependence, and addiction, particularly with NSAIDs.
• Cardiovascular Risks: Acetaminophen, especially sodium-containing formulations, has been linked to increased cardiovascular risks, which could impact its usage[5].
• Regulatory Scrutiny: OTC analgesics are under constant regulatory scrutiny, which can affect their market dynamics.

Opportunities

• Growing Geriatric Population: The increasing geriatric population offers a significant opportunity for growth in the OTC analgesics market.
• Alternative to Opioids: The need for alternatives to opioids due to tolerance and addiction issues presents a substantial market opportunity for acetaminophen and ibuprofen sodium.
• Emerging Markets: Countries like China and India offer lucrative growth opportunities due to their large and growing populations and increasing healthcare expenditures[1][3].

"Acetaminophen is widely regarded as a safe alternative to nonsteroidal anti-inflammatory drugs (NSAIDs) in patients at increased cardiovascular risk, including those taking anticoagulants. However, recent studies have raised concerns about the cardiovascular risks associated with sodium-containing acetaminophen formulations"[5].

Key Takeaways

• The global OTC analgesics market, including acetaminophen and ibuprofen sodium, is growing significantly due to increasing chronic diseases and a rising geriatric population.
• Acetaminophen dominates the market due to its widespread use and recommendation by health organizations.
• Ibuprofen sodium offers faster onset of action and greater efficacy compared to acetaminophen but comes with its own set of risks.
• North America, Europe, and the Asia Pacific are key regions driving market growth.
• Major pharmaceutical companies dominate the market, but regulatory scrutiny and cardiovascular risks pose challenges.

FAQs

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

A: The global acetaminophen market is projected to reach USD 15.2 billion by 2033[3].

Q: How does ibuprofen sodium compare to acetaminophen in terms of analgesic efficacy?

A: Ibuprofen sodium has been shown to have significantly greater analgesic efficacy and faster onset of action compared to acetaminophen, especially in post-operative pain scenarios[2].

Q: What are the main drivers of the OTC analgesics market?

A: The main drivers include the increasing prevalence of chronic diseases, the growing geriatric population, and the need for alternatives to opioids due to tolerance and addiction issues[1][3].

Q: Which regions are expected to witness robust growth in the OTC analgesics market?

A: North America, Europe, and the Asia Pacific, particularly countries like China and India, are expected to witness robust growth[1][3].

Q: What are the potential risks associated with acetaminophen and ibuprofen sodium?

A: Acetaminophen, especially sodium-containing formulations, has been linked to increased cardiovascular risks. Ibuprofen sodium, like other NSAIDs, carries risks such as gastrointestinal issues and cardiovascular effects[5][4].

Sources

1. Coherent Market Insights: Over the Counter (OTC) Analgesics Market Size & Share Analysis.
2. PubMed: Onset of analgesia with sodium ibuprofen, ibuprofen acid.
3. Future Market Insights: Acetaminophen Market Size, Share, Trends & Outlook - 2033.
4. FDA: 201803Orig1s000 - Ibuprofen Sodium.
5. American Heart Association Journals: Acetaminophen, Nonsteroidal Anti-Inflammatory Drugs, and Cardiovascular Risk.