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, Atlantide, Aurobindo Pharma Ltd, Bedford, Facta Farma, Fresenius Kabi Usa, Hospira Inc, Lupin, Qilu, Samson Medcl, Sandoz, Sandoz Inc, Teva, B Braun, Baxter Hlthcare, Astral, Hikma, Hoffmann La Roche, Roche, Akorn, Cephazone Pharma, Hikma Farmaceutica, and Teva Pharms Usa, and is included in forty-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Sponsor	Phase
Johns Hopkins All Children's Hospital	Phase 2
M.D. Anderson Cancer Center	Phase 2
The Grant Medical College & Sir J.J. Group of Hospitals	Phase 4

Sponsor

Phase

Johns Hopkins All Children's Hospital

Phase 2

M.D. Anderson Cancer Center

Phase 2

The Grant Medical College & Sir J.J. Group of Hospitals

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
Cephazone Pharma	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065294-004	Mar 26, 2007		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Facta Farma	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065268-001	Feb 28, 2007		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Astral	CEFTRIAXONE SODIUM	ceftriaxone sodium	INJECTABLE;INJECTION	091117-001	Jan 20, 2017	AP	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Aurobindo Pharma Ltd	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INJECTION	065504-001	Jul 31, 2008		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Hospira Inc	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065230-002	Aug 2, 2005		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Bedford	CEFTRIAXONE	ceftriaxone sodium	INJECTABLE;INTRAMUSCULAR, INTRAVENOUS	065465-002	Aug 18, 2008		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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:	24
NDAs:	41
Drug Master File Entries:	25
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	21
Patent Applications:	7,312
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in ceftriaxone sodium?	ceftriaxone sodium excipients list
DailyMed Link:	ceftriaxone sodium at DailyMed