Dactinomycin - Generic Drug Details

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

Dactinomycin is the generic ingredient in two branded drugs marketed by Recordati Rare, Am Regent, Eugia Pharma, Hikma, Hisun Pharm Hangzhou, Meitheal, and Xgen Pharms, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for dactinomycin. Six suppliers are listed for this compound.

Sponsor	Phase
St. Jude Children's Research Hospital	Phase 1/Phase 2
xiang yang	N/A
University of Birmingham	Phase 1/Phase 2

Sponsor

Phase

St. Jude Children's Research Hospital

Phase 1/Phase 2

xiang yang

N/A

University of Birmingham

Phase 1/Phase 2

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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
Am Regent	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	202562-001	Aug 23, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	213463-001	Nov 13, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xgen Pharms	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	203999-001	May 20, 2019	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	DACTINOMYCIN	dactinomycin	INJECTABLE;INJECTION	203385-001	Nov 9, 2017	AP	RX	No	Yes	⤷ 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:	7
NDAs:	7
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	47
Patent Applications:	2,820
Drug Prices:	Drug price trends for dactinomycin
What excipients (inactive ingredients) are in dactinomycin?	dactinomycin excipients list
DailyMed Link:	dactinomycin at DailyMed

Drug Class	Actinomycin
Mechanism of Action	Nucleic Acid Synthesis Inhibitors Protein Synthesis Inhibitors