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Last Updated: February 23, 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 Glaxosmithkline, 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-two 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
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
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-003 Jan 25, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs IBUPROFEN ibuprofen TABLET;ORAL 071905-001 Mar 8, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Perrigo IBUPROFEN ibuprofen TABLET;ORAL 075995-001 Mar 14, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sunshine IBUPROFEN ibuprofen TABLET;ORAL 204062-001 Sep 10, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma IBUPROFEN ibuprofen SUSPENSION;ORAL 215311-001 May 27, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mcneil Consumer MOTRIN ibuprofen TABLET;ORAL 017463-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz IBUPROFEN ibuprofen TABLET;ORAL 074533-001 Dec 15, 1995 DISCN No No ⤷  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
Glaxosmithkline CHILDREN'S ADVIL ibuprofen SUSPENSION;ORAL 020589-001 Jun 27, 1996 ⤷  Try a Trial ⤷  Try a Trial
J And J Consumer Inc JUNIOR STRENGTH MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020601-003 Nov 15, 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
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-002 Nov 16, 1994 ⤷  Try a Trial ⤷  Try a Trial
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-001 Nov 16, 1994 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline CHILDREN'S ADVIL ibuprofen SUSPENSION;ORAL 019833-002 Sep 19, 1989 ⤷  Try a Trial ⤷  Try a Trial
Mcneil Consumer MOTRIN ibuprofen SUSPENSION;ORAL 019842-001 Sep 19, 1989 ⤷  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
Peru 20150083 FORMULACION DE IBUPROFENO INYECTABLE ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2011008347 ⤷  Try a Trial
South Korea 101864559 ⤷  Try a Trial
Spain 2823249 ⤷  Try a Trial
China 102625656 Treating critically ill patients with intravenous ibuprofen ⤷  Try a Trial
South Korea 101777587 ⤷  Try a Trial
European Patent Office 3417708 ADMINISTRATION D'IBUPROFÈNE PAR VOIE INTRAVEINEUSE (ADMINISTRATION OF INTRAVENOUS IBUPROFEN) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.