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Last Updated: March 29, 2024

Ibuprofen - Generic Drug Details


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What are the generic 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, 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-five 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-three 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

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

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

See all ibuprofen clinical trials

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
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
Bayer MIDOL ibuprofen CAPSULE;ORAL 070626-001 Sep 2, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-003 Jan 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Purepac Pharm IBUPROFEN ibuprofen TABLET;ORAL 071122-001 Oct 3, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma IBUPROFEN ibuprofen TABLET;ORAL 070329-001 Aug 6, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes ⤷  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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mcneil Consumer MOTRIN ibuprofen SUSPENSION;ORAL 019842-001 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
Bionpharma MIDOL LIQUID GELS ibuprofen CAPSULE;ORAL 021472-001 Oct 18, 2002 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings CHILDREN'S ADVIL ibuprofen SUSPENSION;ORAL 019833-002 Sep 19, 1989 ⤷  Try a Trial ⤷  Try a Trial
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-002 Nov 16, 1994 ⤷  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
>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
Australia 2016203946 Injectable Ibuprofen Formulation ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2013138628 ⤷  Try a Trial
China 104302176 Injectable ibuprofen formulation ⤷  Try a Trial
Spain 2647843 ⤷  Try a Trial
South Africa 200504239 Pharmaceutical suspension composition ⤷  Try a Trial
Spain 2694506 ⤷  Try a Trial
>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 ⤷  Try a Trial 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.