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. Eight suppliers are listed for this compound.

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 2
Haiphong University of Medicine and Pharmacy	Phase 2
Universidad Peruana Cayetano Heredia	Phase 3

Sponsor

Phase

University of North Carolina, Chapel Hill

Phase 2

Haiphong University of Medicine and Pharmacy

Phase 2

Universidad Peruana Cayetano Heredia

Phase 3

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUPRAX	for Oral Suspension	cefixime	500 mg/5 mL	202091	1	2016-07-22

Tradename

Dosage

Ingredient

Strength

NDA

ANDAs Submitted

Submissiondate

SUPRAX

for Oral Suspension

cefixime

500 mg/5 mL

202091

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
Lupin Ltd	SUPRAX	cefixime	FOR SUSPENSION;ORAL	202091-001	Feb 20, 2013	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Lupin Pharms	SUPRAX	cefixime	FOR SUSPENSION;ORAL	065129-001	Feb 23, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Belcher	CEFIXIME	cefixime	FOR SUSPENSION;ORAL	206938-001	Feb 6, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	SUPRAX	cefixime	TABLET, CHEWABLE;ORAL	065380-002	Oct 25, 2010		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	CEFIXIME	cefixime	CAPSULE;ORAL	210574-001	Oct 9, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Pharms	SUPRAX	cefixime	TABLET;ORAL	065130-001	Feb 12, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Pharms	SUPRAX	cefixime	FOR SUSPENSION;ORAL	065355-001	Apr 10, 2007	AB	RX	No	Yes	⤷ 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

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

Country

Patent Number

Title

Estimated Expiration

Germany

112007000920

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World Intellectual Property Organization (WIPO)

2007119249

⤷ Sign Up

>Country

>Patent Number

>Title

>Estimated Expiration

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International Patents:	2
US Patents:	1
Tradenames:	2
Applicants:	7
NDAs:	14
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	8
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

Cefixime - Generic Drug Details

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

Summary for cefixime

Recent Clinical Trials for cefixime

Pharmacology for cefixime

Medical Subject Heading (MeSH) Categories for cefixime

Anatomical Therapeutic Chemical (ATC) Classes for cefixime

Paragraph IV (Patent) Challenges for CEFIXIME

US Patents and Regulatory Information for cefixime

International Patents for cefixime

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