CEFTRIAXONE SODIUM - Generic Drug Details

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

Ceftriaxone sodium is the generic ingredient in seven branded drugs marketed by Acs Dobfar, Agila Speclts, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu, Samson Medcl, Sandoz, Sandoz Inc, Teva, Wockhardt, B Braun, Baxter Hlthcare, Anda Repository, Hikma, Hoffmann La Roche, Roche, Astral, Cephazone Pharma, Deva Holding As, Epic Pharma Llc, Hikma Farmaceutica, and Teva Pharms Usa, and is included in forty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for ceftriaxone sodium. Sixteen suppliers are listed for this compound.

Sponsor

Phase

University of Duhok

N/A

Ahmad Zia

Phase 3

Nadeem Iqbal

Phase 3

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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
Qilu	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	203702-003	Jun 29, 2016	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065169-003	May 9, 2005	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira Inc	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065230-004	Aug 2, 2005		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hoffmann La Roche	ROCEPHIN KIT	ceftriaxone sodium; lidocaine	INJECTABLE;INJECTION	050585-006	May 8, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira Inc	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INJECTION	202563-001	Aug 20, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065505-003	Jul 31, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Roche	ROCEPHIN	ceftriaxone sodium	INJECTABLE;INJECTION	062510-002	Mar 12, 1985		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:	7
Applicants:	26
NDAs:	42
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	23
Patent Applications:	7,388
What excipients (inactive ingredients) are in CEFTRIAXONE SODIUM?	CEFTRIAXONE SODIUM excipients list
DailyMed Link:	CEFTRIAXONE SODIUM at DailyMed