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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 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, Taro, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, Amneal Pharms Ny, Ani Pharms Inc, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Granules, Granules India, Halsey, Hec Pharm, Ivax Sub Teva Pharms, Leiner, LNK, Merro Pharm, Mylan, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo Pharms Co, Perrigo R And D, Purepac Pharm, Rising, Sandoz, Shandong Xinhua, Sun Pharm Industries, 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 seventeen NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ibuprofen has sixty-two patent family members in eighteen countries.

There are sixty-four drug master file entries for ibuprofen. Two hundred and nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ibuprofen

International Patents:	62
US Patents:	14
Tradenames:	44
Applicants:	71
NDAs:	217
Drug Master File Entries:	64
Finished Product Suppliers / Packagers:	209
Raw Ingredient (Bulk) Api Vendors:	175
Clinical Trials:	694
Patent Applications:	5,617
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
Apsen Farmaceutica S.A.	Phase 2
Saskatoon City Hospital	N/A
Hackensack Meridian Health	Phase 3

See all ibuprofen clinical trials

Generic filers with tentative approvals for IBUPROFEN

Applicant	Application No.	Strength	Dosage Form
		800MG; 26.6MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

Paragraph IV (Patent) Challenges for IBUPROFEN

Tradename	Dosage	Ingredient	NDA	Submissiondate
INFANT'S ADVIL	SUSPENSION/DROPS;ORAL	ibuprofen	020812	2007-06-29
PEDIATRIC ADVIL	SUSPENSION/DROPS;ORAL	ibuprofen	020812	2007-06-29
CHILDREN'S MOTRIN	SUSPENSION/DROPS;ORAL	ibuprofen	020603
CHILDREN'S MOTRIN	TABLET, CHEWABLE;ORAL	ibuprofen	020601
JUNIOR STRENGTH MOTRIN	TABLET, CHEWABLE;ORAL	ibuprofen	020601

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
Mcneil	MEDIPREN	ibuprofen	TABLET;ORAL	071215-001	Jun 26, 1986		DISCN	No	No
Mcneil	MOTRIN	ibuprofen	SUSPENSION/DROPS;ORAL	020476-001	May 25, 1995		DISCN	No	No
L Perrigo Co	IBUPROFEN	ibuprofen	SUSPENSION/DROPS;ORAL	075217-001	Dec 16, 1998		OTC	No	No
Cumberland Pharms	CALDOLOR	ibuprofen	SOLUTION;INTRAVENOUS	022348-002	Jun 11, 2009		RX	Yes	Yes

Expired US Patents for ibuprofen

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	019833-002	Sep 19, 1989
Glaxosmithkline	CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	020589-001	Jun 27, 1996
J And J Consumer Inc	CHILDREN'S MOTRIN	ibuprofen	SUSPENSION;ORAL	020516-001	Jun 16, 1995
Bionpharma Inc	MIDOL LIQUID GELS	ibuprofen	CAPSULE;ORAL	021472-001	Oct 18, 2002

International Patents for ibuprofen

Country	Patent Number	Estimated Expiration
South Korea	20120138229
Japan	5837877
China	102791268
Spain	2694506