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Ibuprofen - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for ibuprofen?

Ibuprofen is the generic ingredient in forty-four branded drugs marketed by Amneal Pharms, J And J Consumer Inc, Ani Pharms Inc, Bayer, Pfizer, Moberg Pharma North, Vintage Pharms, Marksans Pharma, Watson Labs, Sandoz, Sun Pharm Inds, Superpharm, LNK, Dr Reddys Labs Inc, Granules India Ltd, Aiping Pharm Inc, Perrigo R And D, Ohm Labs, Mcneil, Actavis Mid Atlantic, Perrigo, Mcneil Ped, Purepac Pharm, Halsey, Par Pharm, Lederle, Strides Pharma, Contract Pharmacal, Northstar Hlthcare, Wyeth Cons, Amneal Pharms Ny, Bristol Myers, Aurolife Pharma Llc, P And L Dev Llc, Ivax Sub Teva Pharms, Teva, Mcneil Consumer, Basf, Mylan, Hi-tech Pharmacal, Cumberland Pharms, Abbott, Alra, Tris Pharma Inc, Avema Pharma, Dr Reddys La, OHM, Leiner, Pliva, Humanwell Puracap, Bionpharma Inc, Granules India, Merro Pharm, Sofgen Pharms, Exela Pharma Science, Recordati Rare, Pfizer Cons Hlthcare, Barr Labs Inc, Actavis Elizabeth, Forest Labs, and Dr Reddys Labs Ltd, and is included in one hundred and ninety-nine NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-nine patent family members in eleven countries.

There are sixty-three drug master file entries for ibuprofen. Two hundred and fifty suppliers are listed for this compound.

Summary for Generic Name: ibuprofen

Tradenames:44
Patents:13
Applicants:61
NDAs:199
Drug Master File Entries: see list63
Suppliers / Packagers: see list250
Bulk Api Vendors: see list109
Clinical Trials: see list197
Patent Applications: see list9,521
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ibuprofen at DailyMed

Pharmacology for Ingredient: ibuprofen

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mcneil
MEDIPREN
ibuprofen
TABLET;ORAL071215-001Jun 26, 1986DISCNNoNo► Subscribe► Subscribe
Cumberland Pharms
CALDOLOR
ibuprofen
SOLUTION;INTRAVENOUS022348-002Jun 11, 2009RXYesYes6,727,286► SubscribeY ► Subscribe
Pfizer Cons Hlthcare
ADVIL
ibuprofen sodium
TABLET;ORAL201803-001Jun 12, 2012OTCYesYes► Subscribe► Subscribe
Marksans Pharma
IBUPROFEN
ibuprofen
TABLET;ORAL090796-003Dec 21, 2010RXNoNo► Subscribe► Subscribe
Pfizer
ADVIL COLD AND SINUS
ibuprofen; pseudoephedrine hydrochloride
TABLET;ORAL019771-001Sep 19, 1989OTCYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ibuprofen

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
CHILDREN'S MOTRIN
ibuprofen
TABLET, CHEWABLE;ORAL020601-001Nov 15, 19965,215,755*PED► Subscribe
J And J Consumer Inc
CHILDREN'S MOTRIN
ibuprofen
SUSPENSION;ORAL020516-001Jun 16, 19955,374,659*PED► Subscribe
Mcneil Ped
MOTRIN
ibuprofen
TABLET, CHEWABLE;ORAL020135-001Nov 16, 19945,320,855*PED► Subscribe
Mcneil Ped
MOTRIN
ibuprofen
TABLET, CHEWABLE;ORAL020135-002Nov 16, 19945,215,755*PED► Subscribe
Mcneil Ped
MOTRIN
ibuprofen
TABLET, CHEWABLE;ORAL020135-002Nov 16, 19945,320,855*PED► Subscribe
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International Patent Family for Ingredient: ibuprofen

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2011014208► Subscribe
Japan2013500964► Subscribe
South Korea20120089623► Subscribe
Japan2012523377► Subscribe
Japan2012533542► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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 verifification 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.

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