Bleomycin sulfate - Generic Drug Details

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What are the generic drug sources for bleomycin sulfate and what is the scope of patent protection?

Bleomycin sulfate is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Cipla, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, Pharmachemie Bv, Teva Parenteral, and Teva Pharms Usa, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for bleomycin sulfate. Six suppliers are listed for this compound.

Sponsor	Phase
Jinnah Postgraduate Medical Centre	Phase 2
University of California, Los Angeles	Phase 1
The Emmes Company, LLC	Phase 1

Sponsor

Phase

Jinnah Postgraduate Medical Centre

Phase 2

University of California, Los Angeles

Phase 1

The Emmes Company, LLC

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
Teva Parenteral	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	064084-001	Jun 1, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharmachemie Bv	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	065201-001	Dec 13, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	065033-001	Jun 27, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	065033-002	Jun 27, 2000		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:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	55
Clinical Trials:	79
Patent Applications:	7,511
What excipients (inactive ingredients) are in bleomycin sulfate?	bleomycin sulfate excipients list
DailyMed Link:	bleomycin sulfate at DailyMed