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Last Updated: April 22, 2021

DrugPatentWatch Database Preview

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 nine 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
Saskatoon City HospitalN/A
Hackensack Meridian HealthPhase 3

See all ibuprofen clinical trials

Generic filers with tentative approvals for IBUPROFEN
Applicant Application No. Strength Dosage Form
  Get Started Free  Get Started Free800MG; 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 SUSPENSION/DROPS;ORAL ibuprofen 020603
CHILDREN'S MOTRIN TABLET, CHEWABLE;ORAL ibuprofen 020601
JUNIOR STRENGTH MOTRIN TABLET, CHEWABLE;ORAL ibuprofen 020601

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
Mcneil MEDIPREN ibuprofen TABLET;ORAL 071215-001 Jun 26, 1986 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Mcneil MOTRIN ibuprofen SUSPENSION/DROPS;ORAL 020476-001 May 25, 1995 DISCN No No   Get Started Free   Get Started Free   Get Started Free
L Perrigo Co IBUPROFEN ibuprofen SUSPENSION/DROPS;ORAL 075217-001 Dec 16, 1998 OTC No No   Get Started Free   Get Started Free   Get Started Free
Cumberland Pharms CALDOLOR ibuprofen SOLUTION;INTRAVENOUS 022348-002 Jun 11, 2009 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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 019833-002 Sep 19, 1989   Get Started Free   Get Started Free
Glaxosmithkline CHILDREN'S ADVIL ibuprofen SUSPENSION;ORAL 020589-001 Jun 27, 1996   Get Started Free   Get Started Free
J And J Consumer Inc CHILDREN'S MOTRIN ibuprofen SUSPENSION;ORAL 020516-001 Jun 16, 1995   Get Started Free   Get Started Free
Bionpharma Inc MIDOL LIQUID GELS ibuprofen CAPSULE;ORAL 021472-001 Oct 18, 2002   Get Started Free   Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
Baxter
AstraZeneca
McKesson
Mallinckrodt

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.