CEFACLOR - Generic Drug Details

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

Cefaclor is the generic ingredient in four branded drugs marketed by Lilly, Ceph Intl, Chartwell Rx, Dava Pharms Inc, Hikma, Ivax Sub Teva Pharms, Ranbaxy, Teva, Yung Shin Pharm, Facta Farma, Watson Labs Inc, Ranbaxy Labs Ltd, and World Gen, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for cefaclor. Four suppliers are listed for this compound.

Sponsor	Phase
Fundacion Clinic per a la Recerca Biomédica	Phase 4
Julio Ramirez	Early Phase 1
University of Louisville	Early Phase 1

Sponsor

Phase

Fundacion Clinic per a la Recerca Biomédica

Phase 4

Julio Ramirez

Early Phase 1

University of Louisville

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
Ivax Sub Teva Pharms	CEFACLOR	cefaclor	CAPSULE;ORAL	064061-001	Apr 27, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Yung Shin Pharm	CEFACLOR	cefaclor	FOR SUSPENSION;ORAL	065412-004	Feb 17, 2012		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ranbaxy	CEFACLOR	cefaclor	FOR SUSPENSION;ORAL	064155-001	Oct 2, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ranbaxy Labs Ltd	RANICLOR	cefaclor	TABLET, CHEWABLE;ORAL	065092-001	Dec 22, 2003		DISCN	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:	4
Applicants:	13
NDAs:	33
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	4
Patent Applications:	7,182
Drug Prices:	Drug price trends for CEFACLOR
What excipients (inactive ingredients) are in CEFACLOR?	CEFACLOR excipients list
DailyMed Link:	CEFACLOR at DailyMed