ALBENDAZOLE - Generic Drug Details

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

Albendazole is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Alembic, Chartwell Rx, Cipla Ltd, Dr Reddys, Edenbridge Pharms, MSN, Strides Pharma, Zydus Pharms, and Impax Labs Inc, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for albendazole. Eighteen suppliers are listed for this compound.

Sponsor	Phase
Kintampo Health Research Centre, Ghana	N/A
Public Health Laboratory Ivo de Carneri	Phase 3
National Public Health Institute of Liberia	Phase 2

Sponsor

Phase

Kintampo Health Research Centre, Ghana

N/A

Public Health Laboratory Ivo de Carneri

Phase 3

National Public Health Institute of Liberia

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
Cipla Ltd	ALBENDAZOLE	albendazole	TABLET;ORAL	210434-001	Sep 21, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	ALBENDAZOLE	albendazole	TABLET;ORAL	208979-001	Dec 14, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Edenbridge Pharms	ALBENDAZOLE	albendazole	TABLET;ORAL	211117-001	May 14, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	ALBENDAZOLE	albendazole	TABLET;ORAL	215652-001	Sep 4, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	ALBENZA	albendazole	TABLET;ORAL	020666-001	Jun 11, 1996		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:	10
NDAs:	10
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	119
Patent Applications:	6,015
Drug Prices:	Drug price trends for ALBENDAZOLE
What excipients (inactive ingredients) are in ALBENDAZOLE?	ALBENDAZOLE excipients list
DailyMed Link:	ALBENDAZOLE at DailyMed

Drug Class	Anthelmintic
Mechanism of Action	Cytochrome P450 1A Inducers