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Last Updated: October 2, 2023

Ibuprofen - Generic Drug Details

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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, 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, Taro Pharms, 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, Aurobindo Pharma, 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-four NDAs. There are eleven 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 thirty-five suppliers are listed for this compound.

Summary for ibuprofen

International Patents:	65
US Patents:	11
Tradenames:	44
Applicants:	74
NDAs:	224
Drug Master File Entries:	64
Finished Product Suppliers / Packagers:	235
Raw Ingredient (Bulk) Api Vendors:	200
Clinical Trials:	842
Patent Applications:	7,251
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
United States Department of Defense	Phase 4
Mclean Hospital	Phase 4
University of Miami	Phase 2

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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vintage Pharms	IBUPROFEN	ibuprofen	TABLET;ORAL	072004-001	Nov 18, 1987		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
L Perrigo Co	IBUPROFEN	ibuprofen	TABLET;ORAL	077114-001	Jul 18, 2005		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Basf	IBU	ibuprofen	TABLET;ORAL	070083-001	Feb 22, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	AP	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Strides Pharma	IBUPROFEN	ibuprofen	TABLET;ORAL	070986-001	Jul 25, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	IBUPROFEN	ibuprofen	TABLET;ORAL	213794-002	May 8, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ibuprofen

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-002	Nov 16, 1994	⤷ Try a Trial	⤷ Try a Trial
Bionpharma	MIDOL LIQUID GELS	ibuprofen	CAPSULE;ORAL	021472-001	Oct 18, 2002	⤷ Try a Trial	⤷ Try a Trial
J And J Consumer Inc	JUNIOR STRENGTH MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020601-003	Nov 15, 1996	⤷ Try a Trial	⤷ Try a Trial
J And J Consumer Inc	CHILDREN'S MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020601-001	Nov 15, 1996	⤷ Try a Trial	⤷ Try a Trial
Glaxosmithkline	CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	019833-002	Sep 19, 1989	⤷ Try a Trial	⤷ Try a Trial
J And J Consumer Inc	CHILDREN'S MOTRIN	ibuprofen	SUSPENSION/DROPS;ORAL	020603-001	Jun 10, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for ibuprofen

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for ibuprofen

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Country	Patent Number	Title	Estimated Expiration
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	⤷ Try a Trial
Portugal	2825039		⤷ Try a Trial
Australia	2009350474	Treating critically ill patients with intravenous ibuprofen	⤷ Try a Trial
China	102791268	Treating critically ill patients with intravenous ibuprofen	⤷ Try a Trial
Canada	2767971	TRAITEMENT A BASE D'IBUPROFENE PAR VOIE INTRAVEINEUSE (TREATING PATIENTS WITH INTRAVENOUS IBUPROFEN)	⤷ Try a Trial
Spain	2694506		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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