Dacarbazine - Generic Drug Details

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

Dacarbazine is the generic ingredient in two branded drugs marketed by Abraxis Pharm, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, and Bayer Hlthcare, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for dacarbazine. Three suppliers are listed for this compound.

Sponsor	Phase
Diwakar Davar	Phase 2
IDEAYA Biosciences	Phase 2/Phase 3
Federal Research Institute of Pediatric Hematology, Oncology and Immunology	Phase 3

Sponsor

Phase

Diwakar Davar

Phase 2

IDEAYA Biosciences

Phase 2/Phase 3

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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
Bayer Hlthcare	DTIC-DOME	dacarbazine	INJECTABLE;INJECTION	017575-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075371-002	Aug 27, 1999	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075259-001	Sep 22, 2000	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	075812-002	Oct 31, 2002	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abraxis Pharm	DACARBAZINE	dacarbazine	INJECTABLE;INJECTION	070990-001	Aug 28, 1986		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:	6
NDAs:	7
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	240
Patent Applications:	7,615
Drug Prices:	Drug price trends for dacarbazine
What excipients (inactive ingredients) are in dacarbazine?	dacarbazine excipients list
DailyMed Link:	dacarbazine at DailyMed

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity