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, Chartwell Rx, 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. Seven suppliers are listed for this compound.

Summary for cefixime

International Patents:	2
US Patents:	1
Tradenames:	2
Applicants:	7
NDAs:	14
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	35
Patent Applications:	7,364
Drug Prices:	Drug price trends for cefixime
What excipients (inactive ingredients) are in cefixime?	cefixime excipients list
DailyMed Link:	cefixime at DailyMed

See drug prices for cefixime

Recent Clinical Trials for cefixime

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 2
Haiphong University of Medicine and Pharmacy	Phase 2
AIDS Healthcare Foundation	Phase 3

See all cefixime clinical trials

Pharmacology for cefixime

Drug Class	Cephalosporin Antibacterial

Medical Subject Heading (MeSH) Categories for cefixime

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for cefixime

J01DD	Third-generation cephalosporins
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	CEFIXIME	cefixime	FOR SUSPENSION;ORAL	206144-001	Nov 17, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Belcher	CEFIXIME	cefixime	FOR SUSPENSION;ORAL	206939-001	Feb 6, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	CEFIXIME	cefixime	FOR SUSPENSION;ORAL	204835-002	Apr 14, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for cefixime

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007119249		⤷ Sign Up
Germany	112007000920		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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