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Last Updated: October 2, 2023

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 Pharms, Tris Pharma Inc, Mcneil, Moberg Pharma North, Perrigo, Abbott, Actavis Mid Atlantic, Akorn, Aptapharma Inc, Arise, P And L, Padagis Us, Taro, 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-four NDAs. There are eleven 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.

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
Vintage Pharms IBUPROFEN ibuprofen TABLET;ORAL 072004-001 Nov 18, 1987 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
L Perrigo Co IBUPROFEN ibuprofen TABLET;ORAL 077114-001 Jul 18, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Basf IBU ibuprofen TABLET;ORAL 070083-001 Feb 22, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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
Strides Pharma IBUPROFEN ibuprofen TABLET;ORAL 070986-001 Jul 25, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd IBUPROFEN ibuprofen TABLET;ORAL 213794-002 May 8, 2020 AB RX 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
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-002 Nov 16, 1994 ⤷  Try a Trial ⤷  Try a Trial
Bionpharma MIDOL LIQUID GELS ibuprofen CAPSULE;ORAL 021472-001 Oct 18, 2002 ⤷  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
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020601-001 Nov 15, 1996 ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline CHILDREN'S ADVIL ibuprofen SUSPENSION;ORAL 019833-002 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
>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
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 ⤷  Try a Trial
Portugal 2825039 ⤷  Try a Trial
Australia 2009350474 Treating critically ill patients with intravenous ibuprofen ⤷  Try a Trial
China 102791268 Treating critically ill patients with intravenous ibuprofen ⤷  Try a Trial
Canada 2767971 TRAITEMENT A BASE D'IBUPROFENE PAR VOIE INTRAVEINEUSE (TREATING PATIENTS WITH INTRAVENOUS IBUPROFEN) ⤷  Try a Trial
Spain 2694506 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
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