IBUPROFEN - Generic Drug Details

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

Ibuprofen is the generic ingredient in forty-four branded drugs marketed by Haleon Us Holdings, Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, Onesource Specialty, P And L Dev Llc, Patheon Softgels, Sofgen Pharms, Bayer, Cumberland Pharms, Kenvue Brands, Guardian Drug, L Perrigo Co, Strides Pharma, Sun Pharma Canada, Tris Pharma Inc, Mcneil, Moberg Pharma North, Perrigo, Abbott, Actavis Mid Atlantic, Annora Pharma, Arise, P And L, Padagis Us, Pai Holdings Pharm, Rubicon Research, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, Adaptis, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Avema Pharma, Dr Reddys, Dr Reddys Labs Inc, Granules, Granules India, Halsey, Ivax Sub Teva Pharms, J And J Consumer Inc, Leiner, LNK, Merro Pharm, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo R And D, Ph Health, Pharmobedient, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Strides Pharma Intl, Sun Pharm Industries, Sunshine, Superpharm, Teva, Ultratab Labs Inc, Watson Labs, Yichang Humanwell, Bristol Myers, Xgen Pharms, Recordati Rare, Forest Labs, Actavis Elizabeth, and Barr Labs Inc, and is included in two hundred and twenty-nine NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ibuprofen has fifty-six patent family members in fifteen countries.

There are sixty-four drug master file entries for ibuprofen. Two hundred and forty-three suppliers are listed for this compound.

Summary for IBUPROFEN

International Patents:	56
US Patents:	11
Tradenames:	44
Applicants:	78
NDAs:	229
Drug Master File Entries:	64
Finished Product Suppliers / Packagers:	243
Raw Ingredient (Bulk) Api Vendors:	172
Clinical Trials:	965
Drug Prices:	Drug price trends for IBUPROFEN
Drug Sales Revenues:	Drug sales revenues for IBUPROFEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IBUPROFEN
What excipients (inactive ingredients) are in IBUPROFEN?	IBUPROFEN excipients list
DailyMed Link:	IBUPROFEN at DailyMed

See drug prices for IBUPROFEN

See drug sales revenues for IBUPROFEN

Recent Clinical Trials for IBUPROFEN

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

Sponsor	Phase
Brigham and Women's Hospital	PHASE1
National Institutes of Health (NIH)	PHASE1
Armed Forces Post Graduate Medical Institute (AFPGMI), Rawalpindi	NA

See all IBUPROFEN clinical trials

Pharmacology for IBUPROFEN

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

Medical Subject Heading (MeSH) Categories for IBUPROFEN

Analgesics, Non-Narcotic

Anti-Inflammatory Agents, Non-Steroidal

Cyclooxygenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for 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 IBUPROFEN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOTRIN	Intravenous	ibuprofen	1000 mg/50 mL 2000 mg/100 mL	020418	2	2025-08-26
PEDIATRIC ADVIL	Oral Suspension	ibuprofen	50 mg/1.25 mL	020812	1	2007-06-29

US Patents and Regulatory Information for 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	PEDIATRIC ADVIL	ibuprofen	SUSPENSION/DROPS;ORAL	020812-001	Jan 30, 1998		DISCN	Yes	No
Lnk	IBUPROFEN	ibuprofen	TABLET;ORAL	075139-001	Mar 1, 1999		OTC	No	No
Strides Pharma	IBUPROFEN	ibuprofen	TABLET;ORAL	206989-001	Jun 29, 2018		DISCN	No	No
Ph Health	IBUPROFEN	ibuprofen	TABLET;ORAL	072249-001	Jan 10, 1989		DISCN	No	No
Sun Pharma Canada	IBUPROFEN	ibuprofen	SUSPENSION;ORAL	209204-001	Jun 23, 2017	AB	RX	No	No
Sandoz	IBUPROFEN	ibuprofen	TABLET;ORAL	074533-001	Dec 15, 1995		DISCN	No	No
Ultratab Labs Inc	IBUPROFEN	ibuprofen	TABLET;ORAL	209076-001	Jan 6, 2020		DISCN	No	No

Expired US Patents for IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009
Bionpharma	MIDOL LIQUID GELS	ibuprofen	CAPSULE;ORAL	021472-001	Oct 18, 2002
Haleon Us Holdings	CHILDREN'S ADVIL-FLAVORED	ibuprofen	SUSPENSION;ORAL	020589-002	Nov 7, 1997
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-001	Jun 11, 2009

EU/EMA Drug Approvals for IBUPROFEN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Recordati Rare Diseases	Pedea	ibuprofen	EMEA/H/C/000549Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.	Authorised	no	no	no	2004-07-28

International Patents for IBUPROFEN

Country	Patent Number	Title	Estimated Expiration
Japan	5837877
Denmark	2825039
South Korea	20180063901
World Intellectual Property Organization (WIPO)	2013138628
Japan	2012533542
European Patent Office	2405748
European Patent Office	2825039	PRÉPARATION INJECTABLE À L'IBUPROFÈNE (INJECTABLE IBUPROFEN FORMULATION)

Supplementary Protection Certificates for 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

Market Dynamics and Financial Trajectory for Ibuprofen

Last updated: April 14, 2026

Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID) widely used for pain relief, fever reduction, and inflammation control. Its extensive global use, varied formulations, and evolving market environment influence its commercial performance.

Market Structure and Key Players

The global ibuprofen market features several major pharmaceutical companies involved in manufacturing and distributing generic and branded products. The leading players include:

• Makers of branded formulations: Johnson & Johnson (Motrin), Meda (Nurofen), and others.
• Generic manufacturers: Teva, Sandoz, Mylan, and local producers in emerging markets.

The market is highly fragmented, especially in emerging regions, with local manufacturers supplying over-the-counter (OTC) and prescription formulations.

Market Size and Growth Trends

Estimates for the global ibuprofen market size in 2022 ranged between USD 1.2 billion and USD 1.5 billion, with expectations of growth at a compound annual growth rate (CAGR) of approximately 3-4% over the next five years.

Key Drivers:

• Rising prevalence of chronic pain and inflammation-related conditions.
• Growing awareness and acceptance of OTC NSAIDs.
• Increased healthcare expenditure, especially in Asia-Pacific.

Market Segments:

• OTC sales: Account for roughly 70-75% of total sales.
• Prescription sales: Constitute 25-30%, typically higher in developed markets.

Regional Distribution:

Region	Market Share (2022)	Growth Rate (2022-2027)
North America	40%	3.2%
Europe	25%	3.5%
Asia-Pacific	20%	4.5%
Latin America & Others	15%	3.8%

Emerging markets exhibit higher growth potential due to increasing disposable income and shifting regulatory environments.

Pricing and Revenue Trends

Price sensitivity remains high, particularly for OTC products. Generic formulations dominate the market, leading to intense price competition. Innovative formulations (e.g., sustained-release, combination drugs) command premium prices but account for a smaller market share.

Price Evolution:

• Average retail price for OTC ibuprofen ranges from USD 0.05 to USD 0.20 per tablet, depending on dosage and branding.
• Generic prices have decreased by approximately 5-7% annually over the past five years.

Revenue Drivers:

• Volume sales driven by OTC market penetration.
• Formulation innovations expanding indications and patient compliance.

Regulatory and Patent Landscape

The expiration of key patents in the 2000s led to a surge in generic production, intensifying price competition. Regulatory approvals for new formulations, including liquids, chewables, and topical patches, are expanding market options.

• Patent expiration milestones: Johnson & Johnson's Motrin patent expired in 2007. Sandoz's generic versions grew significantly afterward.
• Regulatory hurdles: Vary by region, with the U.S. FDA and EMA providing clear pathways for generics and new formulations.

Market Challenges and Opportunities

Challenges:

• Market saturation in mature economies.
• Regulatory pressures on safety, especially concerning gastrointestinal and cardiovascular risks.
• Price erosion due to generic competition.

Opportunities:

• Development of new delivery systems (e.g., transdermal patches).
• Expansion into emerging markets.
• Strategic partnerships and licensing.

Financial Trajectory Projections

Based on current market trends, the ibuprofen segment is expected to maintain steady growth with occasional setbacks due to regulatory or supply chain disruptions. Revenue growth hinges on product innovation and market expansion.

Revenue Forecast (2023-2028)

Year	Estimated Market Size (USD billion)	CAGR	Comments
2023	1.3	3.5%	Stable growth, price competition persists
2024	1.35	3.8%	Market expansion in Asia-Pacific
2025	1.4	4.0%	New formulations entering markets
2026	1.45	4.2%	Patent expirations lead to generic proliferation
2027	1.5	4.0%	Market maturity in developed regions

Profitability Outlook

• Gross margins for generic producers: approximately 40-50%.
• Branded formulations: margins up to 55-60%, subject to marketing costs.
• Price erosion impacts net profitability, requiring innovation and cost control.

Key Takeaways

• The ibuprofen market is mature with steady growth driven by OTC sales and emerging markets.
• Generic competition exerts downward pressure on prices and margins.
• Innovation in formulations and regional expansion offer avenues for revenue growth.
• Regulatory environments influence market entry and product approvals.

FAQs

Q1: How does patent expiration affect ibuprofen market dynamics?
Patent expirations increase generic availability, reduce prices, and intensify competition, leading to revenue declines in branded segments but creating growth opportunities for generics.

Q2: What brands dominate the ibuprofen global market?
Meda (Nurofen), Johnson & Johnson (Motrin), and Sandoz are key branded players, although generics account for the majority of sales.

Q3: How important are emerging markets for ibuprofen growth?
Very important; they represent higher growth rates due to increasing healthcare access, rising disposable incomes, and less mature competition.

Q4: What are the main drivers of future ibuprofen market growth?
Market expansion in Asia-Pacific, formulation innovations, and consumer preference for OTC products.

Q5: What regulatory challenges could impact ibuprofen sales?
Safety concerns related to gastrointestinal and cardiovascular risks, coupled with differing regional approval processes, could slow market growth.

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References

[1] MarketWatch. (2023). Ibuprofen market analysis.
[2] Grand View Research. (2022). Nonsteroidal anti-inflammatory drugs market report.
[3] U.S. Food and Drug Administration (FDA). (2023). OTC drug regulations.
[4] European Medicines Agency (EMA). (2023). NSAIDs regulatory pathways.
[5] Smith, J. (2021). "Global OTC pharmaceutical market dynamics." Journal of Pharmaceutical Economics.