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Last Updated: May 24, 2024

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 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-four suppliers are listed for this compound.

Drug Prices for IBUPROFEN

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Drug Sales Revenue Trends for IBUPROFEN

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Recent Clinical Trials for IBUPROFEN

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SponsorPhase
United States Department of DefensePhase 4
Mclean HospitalPhase 4
University of MiamiPhase 2

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Pharmacology for IBUPROFEN
Medical Subject Heading (MeSH) Categories 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sofgen Pharms IBUPROFEN ibuprofen CAPSULE;ORAL 203599-001 Sep 7, 2016 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz IBUPROFEN ibuprofen TABLET;ORAL 072064-001 Jan 14, 1988 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd IBUPROFEN ibuprofen CAPSULE;ORAL 207753-001 Jun 29, 2018 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Basf IBU ibuprofen TABLET;ORAL 018197-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Vintage Pharms IBUPROFEN ibuprofen TABLET;ORAL 071229-001 Apr 1, 1987 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mcneil IBUPROFEN ibuprofen TABLET;ORAL 070476-001 Jun 16, 1986 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz IBUPROFEN ibuprofen TABLET;ORAL 072065-001 Jan 14, 1988 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-002 Nov 16, 1994 ⤷  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;ORAL 020516-001 Jun 16, 1995 ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings CHILDREN'S ADVIL ibuprofen SUSPENSION;ORAL 020589-001 Jun 27, 1996 ⤷  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
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020601-001 Nov 15, 1996 ⤷  Sign Up ⤷  Sign Up
Mcneil Consumer MOTRIN ibuprofen SUSPENSION;ORAL 019842-001 Sep 19, 1989 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

International Patents for IBUPROFEN

Country Patent Number Title Estimated Expiration
South Korea 101777587 ⤷  Sign Up
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 ⤷  Sign Up
Brazil 112012000773 MÉTODO PARA O TRATAMENTO DE PELO MENOS UMA CONDIÇÃO ESCOLHIDA ENTRE DOR, INFLAMAÇÃO E FEBRE EM PACIENTES HUMANOS, MÉTODO PARA O TRATAMENTO DE PACIENTES HUMANOS, MÉTODO PARA O TRATAMENTO DE PELO MENOS UMA CONDIÇÃO ESCOLHIDA ENTRE DOR, INFLAMAÇÃO E FEBRE EM PACIENTES CRITICAMENTE DOENTES, E MÉTODO PARA O TRATAMENTO DE PELO MENOS UMA CONDIÇÃO ESCOLHIDA ENTRE DOR, INFLAMAÇÃO E FEBRE EM PACIENTES CRITICAMENTE DOENTES COM RISCO AUMENTADO DE EVENTOS CARDIOVASCULARES ⤷  Sign Up
China 102469781 Treating patients with intravenous ibuprofen ⤷  Sign Up
Hong Kong 1205877 可注射布洛芬製劑 (INJECTABLE IBUPROFEN FORMULATION) ⤷  Sign Up
China 1988893 Pharmaceutical suspension composition ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2011008347 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IBUPROFEN

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.