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, Aptapharma Inc, Arise, Hi Tech, P And L, Taro, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, Amneal Pharms Ny, Ani Pharms Inc, Aurolife Pharma Llc, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Granules India, Granules India Ltd, 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, Sandoz, Shandong Xinhua, Sun Pharm Industries, Superpharm, Teva, Ultratab Labs Inc, Vintage Pharms, Watson Labs, 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 twenty-two suppliers are listed for this compound.

Summary for ibuprofen

International Patents:	62
US Patents:	14
Tradenames:	44
Applicants:	70
NDAs:	217
Drug Master File Entries:	64
Suppliers / Packagers:	222
Bulk Api Vendors:	164
Clinical Trials:	664
Patent Applications:	7,286
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
DailyMed Link:	ibuprofen at DailyMed

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See drug sales revenues for ibuprofen

Recent Clinical Trials for ibuprofen

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Centro Cardiovascular Universitario	Phase 4
Hospital de Clínicas Dr. Manuel Quintela	Phase 4
Centro Hospitalario Pereyra Rossell	Phase 4

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

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	TABLET, CHEWABLE;ORAL	ibuprofen	020601
JUNIOR STRENGTH MOTRIN	TABLET, CHEWABLE;ORAL	ibuprofen	020601
CHILDREN'S MOTRIN	SUSPENSION/DROPS;ORAL	ibuprofen	020603

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
Recordati Rare	NEOPROFEN	ibuprofen lysine	INJECTABLE;INTRAVENOUS	021903-001	Apr 13, 2006	AP	RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Purepac Pharm	IBUPROFEN	ibuprofen	TABLET;ORAL	071664-001	Feb 3, 1987		DISCN	No	No	Start Trial	Start Trial				Start Trial
Shandong Xinhua	IBUPROFEN	ibuprofen	TABLET;ORAL	207095-001	May 5, 2017		OTC	No	No	Start Trial	Start Trial				Start 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 Consumer	MOTRIN	ibuprofen	SUSPENSION;ORAL	019842-001	Sep 19, 1989	Start Trial	Start Trial
Bionpharma Inc	MIDOL LIQUID GELS	ibuprofen	CAPSULE;ORAL	021472-001	Oct 18, 2002	Start Trial	Start Trial
Mcneil Ped	MOTRIN	ibuprofen	TABLET, CHEWABLE;ORAL	020135-001	Nov 16, 1994	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ibuprofen

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Country	Patent Number	Estimated Expiration
Australia	2010274030	Start Trial
South Korea	101971412	Start Trial
European Patent Office	1748765	Start Trial
>Country	>Patent Number	>Estimated Expiration

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