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Last Updated: March 28, 2024

CEFIXIME - Generic Drug Details


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What are the generic drug sources for cefixime and what is the scope of patent protection?

Cefixime is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Lupin Ltd, Aurobindo Pharma Ltd, Belcher, Sandoz, 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 North Carolina, Chapel HillPhase 2
Haiphong University of Medicine and PharmacyPhase 2
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 Strength NDA ANDAs Submitted Submissiondate
SUPRAX for Oral Suspension cefixime 500 mg/5 mL 202091 1 2016-07-22

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
Lederle SUPRAX cefixime TABLET;ORAL 050621-002 Apr 28, 1989 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd CEFIXIME cefixime FOR SUSPENSION;ORAL 204835-002 Apr 14, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Pharms SUPRAX cefixime TABLET;ORAL 065130-001 Feb 12, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alkem Labs Ltd CEFIXIME cefixime FOR SUSPENSION;ORAL 211775-001 Feb 19, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd SUPRAX cefixime CAPSULE;ORAL 203195-001 Jun 1, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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