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, and Lilly, and is included in fifty-six NDAs. Additional information is available in the individual branded drug profile pages.

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

Sponsor	Phase
Network of Canadian Emergency Researchers (NCER)	Phase 4
Western Sydney Local Health District	Phase 2
Centre Of Research Excellence in Tuberculosis Control	Phase 2

Sponsor

Phase

Network of Canadian Emergency Researchers (NCER)

Phase 4

Western Sydney Local Health District

Phase 2

Centre Of Research Excellence in Tuberculosis Control

Phase 2

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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
Facta Farma	CEPHALEXIN	cephalexin	FOR SUSPENSION;ORAL	062117-003	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin	CEPHALEXIN	cephalexin	CAPSULE;ORAL	065229-002	Nov 25, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ranbaxy Labs Ltd	PANIXINE DISPERDOSE	cephalexin	TABLET, FOR SUSPENSION;ORAL	065100-002	Sep 11, 2003		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Rx	CEPHALEXIN	cephalexin	FOR SUSPENSION;ORAL	065326-002	Jul 10, 2006		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Anda Repository	CEPHALEXIN	cephalexin	CAPSULE;ORAL	065248-001	Jun 28, 2005	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pragma	KEFLEX	cephalexin	FOR SUSPENSION;ORAL	050406-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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:	23
NDAs:	56
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	61
Patent Applications:	6,614
Formulation / Manufacturing:	see details
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