IBUPROFEN - Generic Drug Details

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

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 Pharma, Bayer, Cumberland Pharms, J And J Consumer Inc, Guardian Drug, L Perrigo Co, 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 La, Dr Reddys Labs Inc, Endo Operations, Granules, Granules India, Halsey, Ivax Sub Teva Pharms, 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, Barr Labs Inc, and Dr Reddys Labs Ltd, and is included in two hundred and twenty-seven NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ibuprofen has sixty-five patent family members in nineteen countries.

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

Summary for IBUPROFEN

International Patents:	65
US Patents:	12
Tradenames:	44
Applicants:	75
NDAs:	227
Drug Master File Entries:	64
Finished Product Suppliers / Packagers:	240
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
Aurobindo Pharma Ltd	IBUPROFEN	ibuprofen	CAPSULE;ORAL	215777-001	Sep 14, 2023		DISCN	No	No
Alkem Labs Ltd	IBUPROFEN	ibuprofen	TABLET;ORAL	214699-001	Sep 13, 2021	AB	RX	No	No
Ohm Labs	IBUPROHM	ibuprofen	TABLET;ORAL	070469-001	Aug 29, 1985		DISCN	No	No
Forest Labs	COMBUNOX	ibuprofen; oxycodone hydrochloride	TABLET;ORAL	021378-001	Nov 26, 2004		DISCN	Yes	No
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-003	Jan 25, 2019		RX	Yes	Yes	9,072,710
Annora Pharma	IBUPROFEN	ibuprofen	SUSPENSION;ORAL	210602-001	Nov 23, 2018		OTC	No	No

Expired US Patents for IBUPROFEN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
J And J Consumer Inc	CHILDREN'S MOTRIN	ibuprofen	SUSPENSION;ORAL	020516-001	Jun 16, 1995	5,374,659*PED
Haleon Us Holdings	CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	020589-001	Jun 27, 1996	4,788,220*PED
Bionpharma	MIDOL LIQUID GELS	ibuprofen	CAPSULE;ORAL	021472-001	Oct 18, 2002	6,251,426
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994	5,320,855*PED
J And J Consumer Inc	JUNIOR STRENGTH MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020601-003	Nov 15, 1996	5,215,755*PED
Haleon Us Holdings	CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	019833-002	Sep 19, 1989	4,788,220*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
European Patent Office	2465497	Suspension pharmaceutique (Pharmaceutical suspension composition)
Brazil	PI1006222	uso de ibuprofeno na redução de dor em pacientes humanos que são submetidos a cirurgia, uso de ibuprofeno na redução de dor cirúrgica em pacientes humanos e uso de ibuprofeno para melhorar o tempo ambulatorial após a operação em pacientes humanos que sorem procedimentos cirúrgicos ortopédicos
South Korea	20120089444	TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN
China	102413687	Administration of intravenous ibuprofen
World Intellectual Property Organization (WIPO)	2011079213
Japan	5837877

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

IBUPROFEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ibuprofen

Market Overview

Ibuprofen, a widely used nonsteroidal anti-inflammatory drug (NSAID), is anticipated to experience significant growth in the coming years. The global ibuprofen market was valued at approximately USD 97 million in 2023 and is projected to reach around USD 205.6 million by 2033, growing at a Compound Annual Growth Rate (CAGR) of 7.8% from 2024 to 2033[1][4].

Market Size and Growth Projections

• Global Market Size: The ibuprofen market is expected to grow from USD 97 million in 2023 to USD 205.6 million by 2033, with a CAGR of 7.8%[1].
• Alternative Projections: Another report estimates the market to reach USD 213.6 million by 2033, growing at a CAGR of 7.9% from 2024 to 2033[4].

Segmentation and Market Share

• Formulation Types: The market is segmented into tablets, capsules, syrups, injections, and others. Tablets dominate the market with a 41.6% share in 2023 due to their ease of use[1].
• Application Segments: The rheumatoid arthritis and osteoarthritis segment commands a significant market share of 30.8% in 2023, followed by cancer-related applications and pain relief[1].

Regional Analysis

• North America: This region emerged as the frontrunner in the ibuprofen market in 2023, capturing more than 41.6% of the market share. The robust healthcare expenditure and well-established pharmaceutical industry in North America contribute to its dominant position[1].
• Asia-Pacific: This region is also a significant player, with the market expected to grow due to rising urbanization and increasing public awareness of chronic diseases[5].
• Europe: The European market experienced stability in the first quarter of 2023 but faced challenges in the second quarter due to declining demand and efficient supply chains[2].

Key Drivers of Growth

• Increasing Chronic Pain Conditions: The rising incidence of chronic pain conditions such as rheumatoid arthritis and osteoarthritis drives the demand for ibuprofen[1][3].
• Efficacy and Aging Population: Ibuprofen’s efficacy in pain management, coupled with a growing aging population, supports market growth[1][3].
• Consumer Awareness and Self-Medication: Growing consumer awareness about over-the-counter (OTC) medications and the trend toward self-medication for minor ailments also drive the demand for ibuprofen[5].

Price Trends and Supply Chain Dynamics

• Price Increases: The ibuprofen market experienced upward pricing trends in Q3 2024 due to increased global demand, supply chain disruptions, and higher production costs. Logistical challenges such as port congestion further added to the price pressure[2].
• Supply Chain Constraints: Ongoing supply chain constraints and rising production costs are expected to keep upward pressure on prices. The Chinese yuan's depreciation against the USD also contributed to price increases[2].

Regulatory Challenges

• Stringent Regulatory Framework: The pharmaceutical industry in North America operates within a stringent regulatory framework, which poses challenges to market players. Compliance with regulatory standards and frequent inspections can influence product development timelines and market entry[1].

Competitive Landscape

• Market Players: The ibuprofen market is competitive, with several key players operating within the industry. The availability of ibuprofen through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies, contributes to its accessibility and market growth[1][4].

API Market Dynamics

• Global API Market Size: The global ibuprofen API market was valued at USD 700.8 million in 2023 and is expected to grow at a CAGR of 1.17% from 2024 to 2030. The evolving API scenario in emerging economies and the growing geriatric population are key factors driving this market[3].

Financial Impact on Consumers

• Price Stability and Consumer Costs: Despite fluctuations, the overall price trend of ibuprofen has remained relatively stable in some regions. However, rising drug and healthcare costs continue to be a significant concern, leading to higher out-of-pocket expenses for consumers[2].

Analyst Insights

"The global Ibuprofen market is expected to remain in a bullish phase, driven by continued strong demand from key sectors. Ongoing supply chain constraints and rising production costs will likely keep upward pressure on prices."[2]

Key Takeaways

• The ibuprofen market is projected to grow significantly, driven by increasing chronic pain conditions and a growing aging population.
• Tablets dominate the market due to their ease of use.
• North America is the leading region in the ibuprofen market.
• Regulatory challenges and supply chain constraints pose significant challenges.
• The API market is also expected to grow, albeit at a slower CAGR.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of ibuprofen by 2033? A: The ibuprofen market is expected to reach approximately USD 205.6 million by 2033[1].

Q: What are the key drivers of the ibuprofen market growth? A: The key drivers include increasing chronic pain conditions, ibuprofen’s efficacy, and a growing aging population[1][3].

Q: Which region dominates the ibuprofen market? A: North America dominates the ibuprofen market, capturing more than 41.6% of the market share in 2023[1].

Q: How does the regulatory environment impact the ibuprofen market? A: The stringent regulatory framework in regions like North America poses challenges to market players, influencing product development and market entry[1].

Q: What is the expected CAGR of the global ibuprofen API market from 2024 to 2030? A: The global ibuprofen API market is expected to grow at a CAGR of 1.17% from 2024 to 2030[3].

Cited Sources:

1. Market.us - Ibuprofen Market Size, Share, Growth | CAGR Of 7.8%
2. Procurement Resource - Ibuprofen Price Trend, Index, News, Chart, Database
3. Grand View Research - Ibuprofen API Market Size, Share & Growth Report, 2030
4. PR Newswire - Ibuprofen Market to Reach $213.6 Million, Globally, by 2033 at 7.9% CAGR
5. Straits Research - Global Ibuprofen Market Size, Top Share, CAGR of 2.44%, Report