Cephalexin - Generic Drug Details

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

Cephalexin is the generic ingredient in five branded drugs marketed by Alkem Labs Ltd, Anda Repository, Apothecon, Aurobindo Pharma, Barr, Belcher Pharms, Chartwell Rx, Facta Farma, Hikma, Ivax Sub Teva Pharms, Lupin, Purepac Pharm, Stevens J, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Teva, Yoshitomi, Pragma, Hikma Pharms, Vitarine, Yung Shin Pharm, Ranbaxy Labs Ltd, Aurobindo Pharma Ltd, and Lilly, and is included in fifty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for cephalexin. Thirty-eight suppliers are listed for this compound.

Sponsor

Phase

Brett A Faine

Phase 4

Cairo University

Phase 4

St. Louis University

Phase 4

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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
Apothecon	CEPHALEXIN	cephalexin	CAPSULE;ORAL	062974-001	Nov 23, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Yung Shin Pharm	CEPHALEXIN	cephalexin	FOR SUSPENSION;ORAL	065336-002	Jul 25, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	CEPHALEXIN	cephalexin	CAPSULE;ORAL	062823-001	Feb 5, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vitarine	CEPHALEXIN	cephalexin	TABLET;ORAL	062863-003	Aug 11, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	CEPHALEXIN	cephalexin	CAPSULE;ORAL	062761-001	Apr 24, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	CEPHALEXIN	cephalexin	FOR SUSPENSION;ORAL	062778-001	Aug 6, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apothecon	CEPHALEXIN	cephalexin	CAPSULE;ORAL	063186-001	Dec 30, 1994		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:	5
Applicants:	24
NDAs:	58
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	64
Patent Applications:	7,462
Drug Prices:	Drug price trends for cephalexin
Drug Sales Revenues:	Drug sales revenues for cephalexin
What excipients (inactive ingredients) are in cephalexin?	cephalexin excipients list
DailyMed Link:	cephalexin at DailyMed