BLEOMYCIN SULFATE - Generic Drug Details

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

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
The EMMES Corporation	Phase 1
University of California, Los Angeles	Phase 1

Sponsor

Phase

Jinnah Postgraduate Medical Centre

Phase 2

The EMMES Corporation

Phase 1

University of California, Los Angeles

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	064084-002	Jun 1, 1996		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
Hospira	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	065031-002	Mar 10, 2000	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	205030-002	Apr 20, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Parenteral	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	064084-001	Jun 1, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	BLEOMYCIN SULFATE	bleomycin sulfate	INJECTABLE;INJECTION	065031-001	Mar 10, 2000	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol Myers Squibb	BLENOXANE	bleomycin sulfate	INJECTABLE;INJECTION	050443-002	Sep 7, 1995		DISCN	Yes	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:	7,380
What excipients (inactive ingredients) are in BLEOMYCIN SULFATE?	BLEOMYCIN SULFATE excipients list
DailyMed Link:	BLEOMYCIN SULFATE at DailyMed