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Last Updated: January 30, 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 Inc, 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, 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-two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ibuprofen has sixty-four patent family members in nineteen countries.

There are sixty-four drug master file entries for ibuprofen. Two hundred and twenty-eight 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
Eurofarma Laboratorios S.A.Phase 3
Baylor College of MedicinePhase 4
Alexandria UniversityPhase 4

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
Northstar Hlthcare IBUPROFEN ibuprofen TABLET;ORAL 078132-003 Sep 10, 2007 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunshine IBUPROFEN ibuprofen TABLET;ORAL 204062-002 Sep 10, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Purepac Pharm IBUPROFEN ibuprofen TABLET;ORAL 071124-001 Sep 19, 1986 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Perrigo IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride SUSPENSION;ORAL 076478-001 Nov 5, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys La IBUPROFEN ibuprofen TABLET;ORAL 075682-001 Nov 14, 2001 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alra IBU-TAB 200 ibuprofen TABLET;ORAL 071057-001 Aug 11, 1988 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen SUSPENSION;ORAL 020516-001 Jun 16, 1995 See Plans and Pricing See Plans and Pricing
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-002 Nov 16, 1994 See Plans and Pricing See Plans and Pricing
Bionpharma Inc MIDOL LIQUID GELS ibuprofen CAPSULE;ORAL 021472-001 Oct 18, 2002 See Plans and Pricing See Plans and Pricing
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-002 Nov 16, 1994 See Plans and Pricing See Plans and Pricing
J And J Consumer Inc JUNIOR STRENGTH MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020601-003 Nov 15, 1996 See Plans and Pricing See Plans and Pricing
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-001 Nov 16, 1994 See Plans and Pricing See Plans and Pricing
Mcneil Consumer MOTRIN ibuprofen SUSPENSION;ORAL 019842-001 Sep 19, 1989 See Plans and Pricing See Plans and Pricing
>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
Canada 2785360 TRAITEMENT DE PATIENTS GRAVEMENT ATTEINTS PAR DE L'IBUPROFENE PAR VOIE INTRAVEINEUSE (TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN) See Plans and Pricing
South Korea 101864559 See Plans and Pricing
Australia 2010274030 Treating patients with intravenous ibuprofen See Plans and Pricing
South Korea 20120089444 TREATING CRITICALLY ILL PATIENTS WITH INTRAVENOUS IBUPROFEN See Plans and Pricing
Australia 2013232038 Injectable ibuprofen formulation See Plans and Pricing
Denmark 2825039 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2010105129 See Plans and Pricing
>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.