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-four 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:	244
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
National Institutes of Health (NIH)	PHASE1
Brigham and Women's Hospital	PHASE1
AFT Pharmaceuticals, Ltd.	PHASE3

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
Rising	IBUPROFEN	ibuprofen	TABLET;ORAL	070736-002	Jun 12, 1986		DISCN	No	No
Pliva	IBUPROFEN	ibuprofen	TABLET;ORAL	071666-001	Jun 18, 1987		DISCN	No	No
Bionpharma	IBUPROFEN	ibuprofen	CAPSULE;ORAL	078682-001	Mar 24, 2009		OTC	No	No
Onesource Specialty	IBUPROFEN	ibuprofen	CAPSULE;ORAL	204469-001	Mar 28, 2018		OTC	No	No

Expired US Patents for IBUPROFEN

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

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
Australia	2013232038	Injectable ibuprofen formulation
Australia	2016203946	Injectable Ibuprofen Formulation
Canada	2867477	PREPARATION INJECTABLE A L'IBUPROFENE (INJECTABLE IBUPROFEN FORMULATION)
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.

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