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Last Updated: October 27, 2020

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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, Aptapharma Inc, Arise, Hi Tech, P And L, Taro, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, Amneal Pharms Ny, Ani Pharms Inc, Aurolife Pharma Llc, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Granules India, Granules India Ltd, Halsey, Hec Pharm, Ivax Sub Teva Pharms, Leiner, LNK, Merro Pharm, Mylan, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo Pharms Co, Perrigo R And D, Purepac Pharm, Sandoz, Shandong Xinhua, Sun Pharm Industries, Superpharm, Teva, Ultratab Labs Inc, Vintage Pharms, Watson Labs, 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 seventeen NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ibuprofen has sixty-two patent family members in eighteen countries.

There are sixty-four drug master file entries for ibuprofen. Two hundred and twenty-three suppliers are listed for this compound. There is one tentative approval 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
Children's Hospital of Fudan UniversityPhase 4
National Center for Tuberculosis and Lung Disease, Tbilisi, GeorgiaPhase 2
Perinatal HIV Research Unit of the University of the WitswatersrandPhase 2

See all ibuprofen clinical trials

Generic filers with tentative approvals for IBUPROFEN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial800MG; 26.6MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ibuprofen
Medical Subject Heading (MeSH) Categories for ibuprofen
Paragraph IV (Patent) Challenges for IBUPROFEN
Tradename Dosage Ingredient NDA Submissiondate
INFANT'S ADVIL SUSPENSION/DROPS;ORAL ibuprofen 020812 2007-06-29
PEDIATRIC ADVIL SUSPENSION/DROPS;ORAL ibuprofen 020812 2007-06-29
CHILDREN'S MOTRIN TABLET, CHEWABLE;ORAL ibuprofen 020601
JUNIOR STRENGTH MOTRIN TABLET, CHEWABLE;ORAL ibuprofen 020601
CHILDREN'S MOTRIN SUSPENSION/DROPS;ORAL ibuprofen 020603

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
Bayer MIDOL ibuprofen CAPSULE;ORAL 070626-001 Sep 2, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline CHILDREN'S ADVIL ibuprofen SUSPENSION;ORAL 019833-002 Sep 19, 1989 DISCN No No   Start Trial   Start Trial   Start Trial
Ohm Labs IBUPROHM ibuprofen TABLET;ORAL 070469-001 Aug 29, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz IBUPROFEN ibuprofen TABLET;ORAL 071807-001 Feb 25, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Marksans Pharma IBUPROFEN ibuprofen TABLET;ORAL 091237-001 Feb 8, 2011 OTC No No   Start Trial   Start Trial   Start Trial
Aurolife Pharma Llc IBUPROFEN ibuprofen TABLET;ORAL 071938-001 Jan 14, 1988 DISCN No No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-002 Nov 16, 1994   Start Trial   Start Trial
Bionpharma Inc MIDOL LIQUID GELS ibuprofen CAPSULE;ORAL 021472-001 Oct 18, 2002   Start Trial   Start Trial
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-002 Nov 16, 1994   Start Trial   Start Trial
J And J Consumer Inc JUNIOR STRENGTH MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020601-003 Nov 15, 1996   Start Trial   Start Trial
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-001 Nov 16, 1994   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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.