IBUPROFEN - Generic Drug Details

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What are the generic drug sources for ibuprofen and what is the scope of freedom to operate?

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, P And L Dev Llc, Patheon Softgels, Sofgen Pharms, Strides Pharma, Bayer, Cumberland Pharms, J And J Consumer Inc, Guardian Drug, L Perrigo Co, Taro, Tris Pharma Inc, Mcneil, Moberg Pharma North, Perrigo, Abbott, Actavis Mid Atlantic, Aptapharma Inc, Arise, P And L, Padagis Us, Pai Holdings Pharm, 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-seven NDAs. There are twelve 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:	12
Tradenames:	44
Applicants:	74
NDAs:	227
Drug Master File Entries:	64
Finished Product Suppliers / Packagers:	235
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	865
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
University of Michigan	Phase 1/Phase 2
California Table Grape Commission	Phase 1/Phase 2
University of Nove de Julho	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

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
Contract Pharmacal	IBUPROFEN	ibuprofen	TABLET;ORAL	071735-001	Sep 10, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vintage Pharms	IBUPROFEN	ibuprofen	TABLET;ORAL	072249-001	Jan 10, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aptapharma Inc	IBUPROFEN	ibuprofen	SUSPENSION;ORAL	210602-001	Nov 23, 2018		OTC	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Granules	IBUPROFEN	ibuprofen	TABLET;ORAL	091625-001	Sep 15, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	IBUPROFEN	ibuprofen	TABLET;ORAL	070736-002	Jun 12, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	020135-001	Nov 16, 1994	⤷ Sign Up	⤷ Sign Up
Mcneil Consumer	MOTRIN	ibuprofen	SUSPENSION;ORAL	019842-001	Sep 19, 1989	⤷ Sign Up	⤷ Sign Up
Haleon Us Holdings	CHILDREN'S ADVIL	ibuprofen	SUSPENSION;ORAL	019833-002	Sep 19, 1989	⤷ Sign Up	⤷ Sign Up
Bionpharma	MIDOL LIQUID GELS	ibuprofen	CAPSULE;ORAL	021472-001	Oct 18, 2002	⤷ Sign Up	⤷ Sign Up
J And J Consumer Inc	CHILDREN'S MOTRIN	ibuprofen	SUSPENSION/DROPS;ORAL	020603-001	Jun 10, 1996	⤷ Sign Up	⤷ Sign Up
>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
Portugal	3417708		⤷ Sign Up
South Korea	20120089444	TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN	⤷ Sign Up
South Korea	20180063901	정맥 내 투여용 이부프로펜의 투여 (ADMINISTRATION OF INTRAVENOUS IBUPROFEN)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013138628		⤷ Sign Up
Australia	2010224063	Administration of intravenous ibuprofen	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for IBUPROFEN

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781277	PA2024501	Lithuania	⤷ Sign Up	PRODUCT NAME: IBUPROFENO IR PARACETAMOLIO DERINYS; REGISTRATION NO/DATE: LT/1/23/5212/001-002 20230726
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.