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Last Updated: August 14, 2020

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IBUPROFEN Drug Profile

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When do Ibuprofen patents expire, and when can generic versions of Ibuprofen launch?

Ibuprofen is a drug marketed by 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, Guardian Drug, L Perrigo Co, Tris Pharma Inc, Actavis Mid Atlantic, Aptapharma Inc, Arise, Hi Tech, P And L, Taro, Perrigo, Abbott, 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, J And J Consumer Inc, Lederle, Leiner, LNK, Mcneil, Merro Pharm, Mylan, Northstar Hlthcare, OHM, Ohm Labs, Par Pharm, Perrigo Pharms Co, Perrigo R And D, Pliva, Purepac Pharm, Sandoz, Shandong Xinhua, Sun Pharm Industries, Superpharm, Teva, Ultratab Labs Inc, Vintage Pharms, Watson Labs, Dr Reddys Labs Ltd, and Xgen Pharms. and is included in one hundred and sixty-three NDAs.

The generic ingredient in IBUPROFEN is ibuprofen sodium. There are sixty-four drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ibuprofen sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Ibuprofen

A generic version of IBUPROFEN was approved as ibuprofen sodium by PERRIGO R AND D on August 3rd, 2015.

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Drug patent expirations by year for IBUPROFEN
Drug Prices for IBUPROFEN

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Drug Sales Revenue Trends for IBUPROFEN

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Recent Clinical Trials for IBUPROFEN

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SponsorPhase
Hospital de Clínicas Dr. Manuel QuintelaPhase 4
Centro Hospitalario Pereyra RossellPhase 4
University of the Republic, UruguayPhase 4

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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
Halsey IBUPROFEN ibuprofen TABLET;ORAL 071027-001 Sep 29, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan IBUPROFEN ibuprofen TABLET;ORAL 070045-001 Sep 24, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd IBUPROFEN ibuprofen TABLET;ORAL 208865-001 Nov 8, 2017 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

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