CEFUROXIME AXETIL - Generic Drug Details

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What are the generic drug sources for cefuroxime axetil and what is the scope of freedom to operate?

Cefuroxime axetil is the generic ingredient in two branded drugs marketed by Glaxosmithkline, Sun Pharm Inds Ltd, Alkem Labs Ltd, Anda Repository, Ani Pharms, Apotex, Aurobindo Pharma, Chartwell Rx, Fosun Pharma, Lupin, and Ranbaxy Labs Ltd, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty drug master file entries for cefuroxime axetil. Fifteen suppliers are listed for this compound.

Sponsor	Phase
Julio Ramirez	Early Phase 1
University of Louisville	Early Phase 1
James Graham Brown Cancer Center	Early Phase 1

Sponsor

Phase

Julio Ramirez

Early Phase 1

University of Louisville

Early Phase 1

James Graham Brown Cancer Center

Early Phase 1

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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
Ani Pharms	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065190-001	Oct 18, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fosun Pharma	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065126-001	Oct 28, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Anda Repository	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065359-003	Feb 15, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065069-001	Oct 2, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065069-002	Oct 2, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	CEFTIN	cefuroxime axetil	FOR SUSPENSION;ORAL	050672-001	Jun 30, 1994		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Anda Repository	CEFUROXIME AXETIL	cefuroxime axetil	TABLET;ORAL	065359-002	Feb 15, 2008	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

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	13
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	8
Patent Applications:	5,701
Drug Prices:	Drug price trends for CEFUROXIME AXETIL
What excipients (inactive ingredients) are in CEFUROXIME AXETIL?	CEFUROXIME AXETIL excipients list
DailyMed Link:	CEFUROXIME AXETIL at DailyMed