Acetaminophen; ibuprofen sodium - Generic Drug Details

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

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

Acetaminophen; ibuprofen sodium has seventy patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for acetaminophen; ibuprofen sodium

International Patents:	70
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	10
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
Hospital for Special Surgery, New York	PHASE3
Armed Forces Institute of Dentistry, Pakistan	EARLY_PHASE1
Zitelli & Brodland Skin Cancer Center	PHASE3

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			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
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
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes			Y
Hikma	COMBOGESIC IV	acetaminophen; ibuprofen sodium	SOLUTION;INTRAVENOUS	215320-001	Oct 17, 2023		RX	Yes	Yes

International Patents for acetaminophen; ibuprofen sodium

Country	Patent Number	Title	Estimated Expiration
China	103298464
Tunisia	2017000011	AQUEOUS FORMULATION COMPRISING PARACETAMOL AND IBUPROFEN.
Portugal	2635269
Philippines	12021550804	A COMBINATION COMPOSITION
Australia	2011324137
World Intellectual Property Organization (WIPO)	2016008546
Japan	2017522382	パラセタモール及びイブプロフェンを含む水性配合物

Market Overview and Financial Trajectory for Acetaminophen and Ibuprofen Sodium

Last updated: February 12, 2026

Market Size and Growth Trends

Acetaminophen and ibuprofen sodium are among the most widely used OTC analgesics and antipyretics. The global market for these drugs is projected to surpass $18 billion by 2027, driven by increasing prevalence of pain and fever, aging populations, and expanding OTC channels.

• Acetaminophen: Estimated to hold a market share of approximately 38% within the analgesic segment, with a value approaching $6.8 billion in 2022. The compound is favored in North America due to high consumption rates and regulatory approvals.

• Ibuprofen Sodium: Represents roughly 15% of the global analgesic market, valued at around $2.2 billion in 2022. The sodium salt formulation improves solubility and absorption, expanding its use in both OTC and prescription settings.

Market Drivers and Constraints

• Drivers:

  • Increasing incidence of chronic pain, osteoarthritis, and inflammatory conditions.
  • Growing demand for OTC pain relief options.
  • Launch of new formulations and combination products.
  • Expansion into emerging markets with rising healthcare access.

• Constraints:

  • Regulatory concerns about acetaminophen-related hepatotoxicity.
  • Cardiac risk associated with ibuprofen in high doses or long-term use.
  • Competition from alternative OTC analgesics (e.g., aspirin, naproxen).

Regulatory Environment

Regulatory agencies, including the FDA (United States), EMA (Europe), and other national bodies, monitor safety profiles of these drugs.

• Acetaminophen: Limits on maximum daily doses (4,000 mg for adults in the US). Ongoing research investigates safer formulations to mitigate hepatotoxicity risks.

• Ibuprofen Sodium: Approved for OTC use in standard doses. Higher doses or prolonged use require prescription oversight due to potential gastrointestinal and cardiovascular side effects.

Patents and Market Exclusivity

• Acetaminophen: Patents have long expired; generic markets dominate, resulting in price competition and lower margins. Innovative formulations or combinations may hold patent protection.

• Ibuprofen Sodium: Some formulations protected by patents expiring between 2024 and 2030. Patent expirations open avenues for generics and biosimilars, pressuring pricing.

Competitive Landscape

• Major Players: Johnson & Johnson, Pfizer, GlaxoSmithKline, and Bayer dominate production for both drugs, especially in OTC segments.

• Generic Manufacturers: Comprise a significant portion of the market, offering lower-cost options and impacting brand pricing strategies.

Financial Trajectory

• Revenue Trends: The global OTC analgesic market is growing at a compound annual growth rate (CAGR) of approximately 4.1% (2017-2022). Acetaminophen and ibuprofen sodium will follow this trend, with market expansion largely in emerging economies.

• Profit Margins: Typically range from 20% to 30%, influenced heavily by patent status, manufacturing costs, and regulatory requirements.

• R&D Spending: Focused on reformulations to improve safety profiles, combination products, and novel delivery mechanisms.

Emerging Opportunities

• Development of acetaminophen derivatives with reduced hepatotoxicity.
• Enhanced bioavailability formulations of ibuprofen sodium.
• Combination therapies targeting specific pain conditions.
• Entry into growing markets in Asia-Pacific and Latin America.

Risks and Challenges

• Regulatory restrictions due to safety concerns.
• Increased competition from non-NSAID analgesics.
• Potential shifts in consumer preferences toward alternative therapies.

Summary Table

Attribute	Acetaminophen	Ibuprofen Sodium
Market Value (2022)	$6.8 billion	$2.2 billion
Market Share (analgesics)	38%	15%
Growth Rate (CAGR 2017-2022)	3.5%	4.3%
Patent Status	Patents expired	Patents expiring 2024-2030
Major Players	Johnson & Johnson,-GSK	Pfizer, Bayer
Regulatory Concerns	Hepatotoxicity	GI, cardiovascular risks

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Key Takeaways

• Both drugs operate in a mature market with steady growth driven by demographic trends and OTC demand.
• Patent expirations open opportunities for generic entrants, impacting margins.
• Safety concerns influence regulatory decisions and product formulations.
• Entry into emerging markets is critical for future growth.
• Investment in reformulation and combination products represents a strategic focus.

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FAQs

1. How does patent expiration affect acetaminophen and ibuprofen sodium?
Patent expiration leads to increased generic competition, reducing prices and profit margins for branded products. Companies may pursue reformulation or new combinations to extend market exclusivity.

2. What regulatory challenges do these drugs face?
Acetaminophen faces restrictions due to hepatotoxicity potential, leading to limits on maximum doses. Ibuprofen sodium is scrutinized for gastrointestinal and cardiovascular risks, especially at higher doses or prolonged use.

3. Are new formulations or delivery methods expected for these drugs?
Yes. Research focuses on safer acetaminophen formulations, extended-release forms, and improved bioavailability of ibuprofen sodium to enhance safety and efficacy.

4. Which markets are driving future growth?
Emerging markets in Asia-Pacific and Latin America are expanding rapidly, owing to rising healthcare access, increasing disposable incomes, and shifting consumer preferences.

5. What is the outlook on profitability for companies involved?
Margins are decreasing due to generic competition and regulatory constraints but remain sustainable through innovation, efficient manufacturing, and newer indications or formulations.

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References

[1] MarketsandMarkets. OTC Analgesics Market Report, 2022.
[2] IQVIA. Global OTC Pharmaceutical Market Analysis, 2022.
[3] FDA. Acetaminophen Information, 2022.
[4] EMA. Ibuprofen Sodium Summary of Product Characteristics, 2022.