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Last Updated: July 10, 2020

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CEFIXIME Drug Profile


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US ANDA Litigation and Generic Entry Outlook for Cefixime

A generic version of CEFIXIME was approved as cefixime by AUROBINDO PHARMA LTD on April 14th, 2015.

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Drug patent expirations by year for CEFIXIME
Drug Prices for CEFIXIME

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Recent Clinical Trials for CEFIXIME

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SponsorPhase
Department for International Development, United KingdomPhase 4
Wellcome TrustPhase 4
Medical Research CouncilPhase 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
Alkem Labs Ltd CEFIXIME cefixime CAPSULE;ORAL 210574-001 Oct 9, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc CEFIXIME cefixime FOR SUSPENSION;ORAL 206144-001 Nov 17, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Belcher CEFIXIME cefixime FOR SUSPENSION;ORAL 206938-001 Feb 6, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc CEFIXIME cefixime FOR SUSPENSION;ORAL 206144-002 Nov 17, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd CEFIXIME cefixime FOR SUSPENSION;ORAL 204835-001 Apr 14, 2015 AB RX 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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Serving leading biopharmaceutical companies globally:

Moodys
Merck
McKinsey
AstraZeneca
McKesson
Express Scripts

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