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 Glaxosmithkline, Amneal Pharms, Ascent Pharms Inc, Aurobindo Pharma Ltd, Bionpharma Inc, Contract Pharmacal, Humanwell Puracap, Marksans Pharma, P And L Dev Llc, Sofgen Pharms, Strides Pharma, Bayer, Cumberland Pharms, J And J Consumer Inc, Guardian Drug, L Perrigo Co, Tris Pharma Inc, Mcneil, Moberg Pharma North, Perrigo, Abbott, Actavis Mid Atlantic, Akorn, Aptapharma Inc, Arise, P And L, Padagis Us, Taro, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Granules, Granules India, Halsey, Ivax Sub Teva Pharms, Leiner, LNK, Merro Pharm, Mylan, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo R And D, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Sun Pharm Industries, Sunshine, Superpharm, Teva, Ultratab Labs Inc, Vintage Pharms, 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 NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for ibuprofen

International Patents:	64
US Patents:	11
Tradenames:	44
Applicants:	72
NDAs:	220
Drug Master File Entries:	64
Finished Product Suppliers / Packagers:	207
Raw Ingredient (Bulk) Api Vendors:	184
Clinical Trials:	791
Patent Applications:	5,980
Formulation / Manufacturing:	see details
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
Eurofarma Laboratorios S.A.	Phase 3
Ottawa Hospital Research Institute	Early Phase 1
Kyongbo Pharmaceutical	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
Glaxosmithkline	ADVIL MIGRAINE LIQUI-GELS	ibuprofen	CAPSULE;ORAL	020402-002	Mar 16, 2000		OTC	Yes	Yes
Vintage Pharms	IBUPROFEN	ibuprofen	TABLET;ORAL	071229-001	Apr 1, 1987		OTC	No	No
Ohm	IBUPROFEN	ibuprofen	TABLET;ORAL	071163-001	Jul 15, 1986		OTC	No	No
Aurobindo Pharma Ltd	IBUPROFEN	ibuprofen	TABLET;ORAL	213794-003	May 8, 2020	AB	RX	No	No
Alkem Labs Ltd	IBUPROFEN	ibuprofen	TABLET;ORAL	214699-003	Sep 13, 2021	AB	RX	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
Mcneil Consumer	MOTRIN	ibuprofen	SUSPENSION;ORAL	019842-001	Sep 19, 1989
J And J Consumer Inc	CHILDREN'S MOTRIN	ibuprofen	SUSPENSION/DROPS;ORAL	020603-001	Jun 10, 1996
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994
Bionpharma Inc	MIDOL LIQUID GELS	ibuprofen	CAPSULE;ORAL	021472-001	Oct 18, 2002

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
South Korea	101864559
South Korea	20170091775	정맥 내 투여용 이부프로펜의 투여 (ADMINISTRATION OF INTRAVENOUS IBUPROFEN)
South Korea	20120138229	TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN
Australia	2009350474	Treating critically ill patients with intravenous ibuprofen
Australia	2010224063	Administration of intravenous ibuprofen