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Last Updated: September 19, 2020

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IBUPROFEN SODIUM - Generic Drug Details

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What are the generic sources for ibuprofen sodium and what is the scope of freedom to operate?

Ibuprofen sodium is the generic ingredient in two branded drugs marketed by Glaxosmithkline and Perrigo R And D, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-four drug master file entries for ibuprofen sodium. Eight suppliers are listed for this compound.

Recent Clinical Trials for IBUPROFEN SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of California, San DiegoPhase 4
Society of Family PlanningPhase 4
Northwestern UniversityPhase 4

See all IBUPROFEN SODIUM clinical trials

US Patents and Regulatory Information for IBUPROFEN SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Perrigo R And D IBUPROFEN SODIUM ibuprofen sodium TABLET;ORAL 206581-001 Aug 3, 2015 OTC No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline ADVIL ibuprofen sodium TABLET;ORAL 201803-001 Jun 12, 2012 OTC Yes Yes   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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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Moodys
McKinsey
Colorcon
Johnson and Johnson

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