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Last Updated: February 25, 2021

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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, Akorn, Aptapharma Inc, Arise, P And L, Taro, Mcneil Consumer, Mcneil Ped, Lederle, Basf, Alra, Pliva, Amneal Pharms Ny, Ani Pharms Inc, Avema Pharma, Dr Reddys La, Dr Reddys Labs Inc, Granules, Granules India, 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, Rising, Sandoz, Shandong Xinhua, Sun Pharm Industries, 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 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 eight 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
Apsen Farmaceutica S.A.Phase 2
Children's Hospital of Fudan UniversityPhase 4
Fraser HealthN/A

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
Strides Pharma IBUPROFEN ibuprofen TABLET;ORAL 206989-001 Jun 29, 2018 OTC No No   Start Trial   Start Trial   Start Trial
Basf IBU ibuprofen TABLET;ORAL 070099-001 Mar 29, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Contract Pharmacal IBUPROFEN ibuprofen TABLET;ORAL 074931-001 Jul 20, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Strides Pharma IBUPROFEN ibuprofen TABLET;ORAL 078329-001 Feb 5, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Sofgen Pharms IBUPROFEN ibuprofen CAPSULE;ORAL 203599-001 Sep 7, 2016 OTC No No   Start Trial   Start Trial   Start Trial
Humanwell Puracap IBUPROFEN ibuprofen CAPSULE;ORAL 206568-001 Jun 21, 2016 OTC No No   Start Trial   Start Trial   Start Trial
Amneal Pharms IBUPROFEN ibuprofen TABLET;ORAL 079233-001 Mar 18, 2014 OTC 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
Bionpharma Inc MIDOL LIQUID GELS ibuprofen CAPSULE;ORAL 021472-001 Oct 18, 2002   Start Trial   Start Trial
Glaxosmithkline CHILDREN'S ADVIL ibuprofen SUSPENSION;ORAL 020589-001 Jun 27, 1996   Start Trial   Start Trial
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-001 Nov 16, 1994   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen SUSPENSION;ORAL 020516-001 Jun 16, 1995   Start Trial   Start Trial
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020601-001 Nov 15, 1996   Start Trial   Start Trial
Mcneil Ped MOTRIN ibuprofen TABLET, CHEWABLE;ORAL 020135-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
McKinsey
Express Scripts
Colorcon
Boehringer Ingelheim

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