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, P And L Dev Llc, Patheon Softgels, Sofgen Pharms, Strides Softgels, Bayer, Cumberland Pharms, Kenvue Brands, Guardian Drug, L Perrigo Co, Strides Pharma, Taro, Tris Pharma Inc, Mcneil, Moberg Pharma North, Perrigo, Abbott, Actavis Mid Atlantic, Annora Pharma, Arise, P And L, Padagis Us, Pai Holdings Pharm, 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, Endo Operations, Granules, Granules India, Halsey, Ivax Sub Teva Pharms, J And J Consumer Inc, Leiner, LNK, Merro Pharm, Northstar Hlthcare, Norvium Bioscience, OHM, Ohm Labs, Par Pharm, Perrigo R And D, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, 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-eight 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:	76
NDAs:	228
Drug Master File Entries:	64
Finished Product Suppliers / Packagers:	243
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	865
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
University of Michigan	Phase 1/Phase 2
California Table Grape Commission	Phase 1/Phase 2
University of Nove de Julho	N/A

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
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
Kenvue Brands	JUNIOR STRENGTH MOTRIN	ibuprofen	TABLET;ORAL	020602-001	Jun 10, 1996		OTC	No	No
P And L Dev Llc	IBUPROFEN	ibuprofen	TABLET;ORAL	070733-001	Sep 19, 1986		DISCN	No	No
Purepac Pharm	IBUPROFEN	ibuprofen	TABLET;ORAL	071124-001	Sep 19, 1986		DISCN	No	No
Sandoz	IBUPROFEN	ibuprofen	TABLET;ORAL	074533-001	Dec 15, 1995		DISCN	No	No
Haleon Us Holdings	JUNIOR STRENGTH ADVIL	ibuprofen	TABLET, CHEWABLE;ORAL	020944-002	Dec 18, 1998		OTC	No	No

Expired US Patents for IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994	5,215,755*PED
Mcneil Consumer	MOTRIN	ibuprofen	SUSPENSION;ORAL	019842-001	Sep 19, 1989	5,374,659*PED
Bionpharma	MIDOL LIQUID GELS	ibuprofen	CAPSULE;ORAL	021472-001	Oct 18, 2002	6,251,426
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994	5,215,755*PED
Kenvue Brands	CHILDREN'S MOTRIN	ibuprofen	SUSPENSION/DROPS;ORAL	020603-001	Jun 10, 1996	5,374,659*PED

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/000549 Treatment 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
Chile	2014002414	Composicion farmaceutica inyectable que comprende ibuprofeno, una solucion acuosa y un agente solubilizante seleccionado de fosfatos de sodio, de potasio, carbonatos de sodio, de potasio y/o combinaciones de ellos.
South Korea	20170091775	정맥 내 투여용 이부프로펜의 투여 (ADMINISTRATION OF INTRAVENOUS IBUPROFEN)
Portugal	3417708
South Korea	20120089623	TREATING PATIENTS WITH INTRAVENOUS IBUPROFEN
China	102625656	Treating critically ill patients with intravenous ibuprofen

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 of Ibuprofen

Last updated: July 3, 2025

Introduction

Ibuprofen, a widely used nonsteroidal anti-inflammatory drug (NSAID), has transformed pain management since its introduction in the 1960s. As a generic staple for treating conditions like arthritis, headaches, and fever, it drives billions in annual sales. This analysis examines the current market dynamics and financial trajectory of ibuprofen, offering insights for business professionals navigating the pharmaceutical sector. With its off-patent status and global demand, ibuprofen exemplifies how mature drugs sustain profitability amid competition and regulatory shifts.

Current Market Dynamics

The ibuprofen market thrives on high demand from over-the-counter (OTC) and prescription segments, fueled by an aging population and rising chronic pain prevalence. In 2023, the global market reached approximately $1.5 billion, according to industry data, with projections indicating steady growth at a compound annual growth rate (CAGR) of 3-5% through 2030. This expansion stems from emerging markets in Asia-Pacific and Latin America, where increasing healthcare access boosts consumption.

Key players include major manufacturers like Pfizer, Johnson & Johnson, and generic producers such as Teva Pharmaceutical Industries and Dr. Reddy's Laboratories. These companies leverage economies of scale to dominate supply chains, with Pfizer holding a significant share in branded formulations. Competition intensifies in the generic space, where low barriers to entry have led to over 100 suppliers worldwide, compressing margins and driving price wars.

Regionally, North America leads with about 40% of global revenue, driven by robust OTC sales through retailers like Walmart and CVS. Europe follows, with strict regulations from the European Medicines Agency (EMA) ensuring quality standards. In contrast, Asia-Pacific markets, particularly India and China, experience rapid growth due to urbanization and expanding middle-class populations. Demand drivers include the drug's affordability—typically costing under $0.10 per dose—and its role in pandemic recovery, as ibuprofen sales surged during COVID-19 for symptom relief.

Emerging trends, such as sustainable packaging and combination therapies (e.g., ibuprofen with acetaminophen), add complexity. For instance, innovations like delayed-release formulations aim to reduce gastrointestinal side effects, appealing to health-conscious consumers. However, supply chain disruptions, highlighted by the 2022 global shortages, underscore vulnerabilities in raw material sourcing from China and India.

Financial Trajectory

Ibuprofen's financial path reflects a shift from high-margin branded sales to commoditized generics. In the 1990s, original patent holder Boots (now part of GSK) generated peak revenues exceeding $500 million annually. Post-1985 patent expiration in the U.S., revenues decentralized, with global sales stabilizing at $1.2-1.6 billion yearly.

Financial performance varies by company. Pfizer reported ibuprofen-related revenues of around $200 million in 2022, bolstered by its Advil brand. Generics dominate, accounting for 80% of sales, where Teva and others achieve gross margins of 30-40% through cost efficiencies. Recent quarterly data from IQVIA shows a 2% year-over-year increase in ibuprofen volumes, offset by 5-10% price declines due to generic competition.

Looking ahead, financial projections hinge on market expansion in developing regions. By 2028, analysts forecast revenues to hit $1.8 billion, driven by a 4% CAGR. This growth assumes stable raw material costs and no major regulatory hurdles. R&D investments remain modest for ibuprofen, as companies prioritize line extensions—such as low-dose pediatric versions—over new molecule development. For example, Johnson & Johnson's 2023 investments in OTC enhancements yielded a 15% return on ibuprofen lines.

Challenges include inflationary pressures on production, with costs rising 20% in 2023 due to energy and labor expenses. Despite this, the drug's low manufacturing complexity ensures profitability for efficient players. Financial models from Deloitte indicate that ibuprofen could deliver stable cash flows, with return on investment (ROI) averaging 10-15% for generic manufacturers.

Competitive Landscape

The ibuprofen market features a fragmented competitive environment, pitting branded giants against a multitude of generics. Pfizer and GSK maintain leadership in OTC segments through marketing and distribution networks, capturing 25% of the market share combined. Generics from Teva and Mylan (now Viatris) control the rest, leveraging bulk production to undercut prices by 50-70%.

New entrants, such as Chinese firms like Sinopharm, intensify rivalry by offering ultra-low-cost alternatives, particularly in export markets. This dynamic pressures established players to innovate, as seen in Haleon's 2023 launch of flavored ibuprofen gels for children, which gained 5% market share in Europe. Barriers to entry are low for generics but high for differentiated products requiring FDA approvals.

Strategic alliances, like Johnson & Johnson's partnerships with retail chains, enhance distribution and boost sales volumes. Meanwhile, environmental factors—such as the push for eco-friendly packaging—create opportunities for companies investing in sustainable practices, potentially reshaping competitive edges.

Regulatory and Patent Aspects

Ibuprofen's patent landscape, expired globally since the 1980s, emphasizes regulatory compliance over intellectual property protection. The FDA classifies it as a generally recognized as safe and effective (GRASE) substance, facilitating generic approvals. Recent updates, including the 2022 FDA guidance on NSAID labeling for cardiovascular risks, mandate clearer warnings, impacting sales strategies.

In Europe, the EMA's periodic safety reviews ensure ongoing monitoring, with 2023 directives focusing on pediatric dosing. These regulations add compliance costs, estimated at 5-10% of production expenses for manufacturers. Emerging markets present opportunities, as India's CDSCO streamlines approvals for affordable generics, fueling exports.

Patent-related dynamics now center on secondary innovations, like novel delivery systems. For instance, a 2021 patent by Reckitt Benckiser for extended-release ibuprofen highlights how companies extend product lifecycles amid a patent-free core molecule.

Challenges and Opportunities

Ibuprofen faces headwinds from side effect concerns, including gastrointestinal and renal risks, which could erode consumer trust. A 2023 study in the Journal of the American Medical Association linked prolonged use to higher health risks, prompting regulatory scrutiny and potential demand shifts toward alternatives like acetaminophen.

Conversely, opportunities abound in untapped markets. Africa's growing pharmaceutical sector offers a 10% annual growth potential, where affordable ibuprofen could address unmet needs. Digital health trends, such as AI-driven dosage apps, integrate ibuprofen into personalized medicine, enhancing its value.

Sustainability initiatives, like reducing plastic in packaging, align with global trends and could differentiate products. Companies investing in these areas, such as GSK's 2024 eco-friendly line, position themselves for long-term gains amid evolving consumer preferences.

Conclusion

Ibuprofen remains a cornerstone of the pharmaceutical industry, balancing mature market dynamics with resilient financial performance. As demand evolves, stakeholders must navigate competition, regulations, and innovation to sustain profitability. This analysis equips business professionals with actionable insights to inform strategic decisions in a dynamic landscape.

Key Takeaways

• Global market growth: Ibuprofen sales are projected to reach $1.8 billion by 2028, driven by emerging markets and OTC demand.
• Financial stability: Despite price pressures, efficient manufacturers achieve 30-40% gross margins through cost controls.
• Competitive pressures: Generics dominate 80% of the market, challenging branded players to innovate in formulations and distribution.
• Regulatory focus: Ongoing FDA and EMA reviews emphasize safety, potentially influencing future sales and compliance costs.
• Future opportunities: Expansion in Asia-Pacific and sustainable practices offer pathways for revenue growth amid challenges.

FAQs

1. What factors are driving the current growth in the ibuprofen market?
   Growth stems from increasing chronic pain prevalence in aging populations and expanded access in emerging markets, with a projected CAGR of 3-5% through 2030.

2. How has the expiration of ibuprofen's patent affected its financial trajectory?
   Patent expiration shifted focus to generics, reducing prices by 50-70% and decentralizing revenues, but enabling broader market penetration and stable cash flows.

3. What role do regulatory bodies play in ibuprofen's market dynamics?
   Agencies like the FDA and EMA enforce safety standards and labeling updates, which can increase compliance costs but also ensure long-term consumer trust.

4. How do emerging markets impact ibuprofen's competitive landscape?
   Regions like Asia-Pacific and Africa provide new growth avenues for generics, intensifying competition and prompting innovations in affordable formulations.

5. What financial risks should investors consider for ibuprofen-related investments?
   Risks include supply chain disruptions, price erosion from generics, and regulatory changes affecting sales, though stable demand offers a buffer for diversified portfolios.

Sources

1. IQVIA Institute. "Global Use of Medicines 2023 Outlook." Accessed via IQVIA reports on pharmaceutical market trends.
2. Deloitte. "2023 Pharma Sector Analysis: Financial Projections for Generic Drugs." Available in Deloitte's industry publications.
3. Journal of the American Medical Association. "NSAID Safety Review, 2023." Published study on ibuprofen risks.