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Last Updated: October 20, 2021

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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 fourteen 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. Eight suppliers are listed for this compound.

Summary for cefixime
Drug Prices for cefixime

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Recent Clinical Trials for cefixime

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

SponsorPhase
University of Southern CaliforniaPhase 3
AIDS Healthcare FoundationPhase 3
Universidad Peruana Cayetano HerediaPhase 3

See all cefixime clinical trials

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
Lupin Pharms SUPRAX cefixime FOR SUSPENSION;ORAL 065355-001 Apr 10, 2007 AB RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lederle SUPRAX cefixime FOR SUSPENSION;ORAL 050622-001 Apr 28, 1989 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Belcher CEFIXIME cefixime FOR SUSPENSION;ORAL 206938-001 Feb 6, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sandoz Inc CEFIXIME cefixime FOR SUSPENSION;ORAL 206144-001 Nov 17, 2017 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alkem Labs Ltd CEFIXIME cefixime CAPSULE;ORAL 210574-001 Oct 9, 2018 RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alkem Labs Ltd CEFIXIME cefixime FOR SUSPENSION;ORAL 211775-002 Feb 19, 2021 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Belcher CEFIXIME cefixime FOR SUSPENSION;ORAL 206939-001 Feb 6, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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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