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Last Updated: July 10, 2020

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Cefixime - Generic Drug Details

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

Cefixime is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Lupin Ltd, Aurobindo Pharma Ltd, Belcher, Sandoz Inc, Lederle, and Lupin Pharms, and is included in thirteen NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cefixime has two patent family members in two countries.

There are fourteen drug master file entries for cefixime. Ten suppliers are listed for this compound.

Drug Prices for cefixime

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Recent Clinical Trials for cefixime

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SponsorPhase
Medical Research CouncilPhase 4
Oxford University Clinical Research Unit, VietnamPhase 4
University of OxfordPhase 4

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Pharmacology for cefixime
Medical Subject Heading (MeSH) Categories for cefixime
Paragraph IV (Patent) Challenges for CEFIXIME
Tradename Dosage Ingredient NDA Submissiondate
SUPRAX FOR SUSPENSION;ORAL cefixime 202091 2016-07-22
SUPRAX FOR SUSPENSION;ORAL cefixime 202091 2014-07-22

US Patents and Regulatory Information for cefixime

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd CEFIXIME cefixime FOR SUSPENSION;ORAL 204835-002 Apr 14, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd SUPRAX cefixime TABLET, CHEWABLE;ORAL 065380-001 Oct 25, 2010 RX No No   Start Trial   Start Trial   Start Trial
Lupin Pharms SUPRAX cefixime FOR SUSPENSION;ORAL 065355-001 Apr 10, 2007 AB RX No Yes   Start Trial   Start Trial   Start Trial
Lupin Ltd SUPRAX cefixime TABLET, CHEWABLE;ORAL 065380-003 Oct 25, 2010 RX No Yes   Start Trial   Start Trial   Start Trial
Lederle SUPRAX cefixime TABLET;ORAL 050621-001 Apr 28, 1989 DISCN Yes 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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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Boehringer Ingelheim
AstraZeneca
McKinsey
Mallinckrodt

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