Phenoxybenzamine hydrochloride - Generic Drug Details

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

Phenoxybenzamine hydrochloride is the generic ingredient in two branded drugs marketed by Concordia, Amneal, Aurobindo Pharma, Endo Operations, Hikma, Novitium Pharma, and Rising, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for phenoxybenzamine hydrochloride. Seven suppliers are listed for this compound.

Sponsor	Phase
Seoul National University Hospital	Phase 4
University of California, Los Angeles	Phase 3
UMC Utrecht	Phase 4

Sponsor

Phase

Seoul National University Hospital

Phase 4

University of California, Los Angeles

Phase 3

UMC Utrecht

Phase 4

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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
Rising	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	204551-001	Jun 20, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Concordia	DIBENZYLINE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	008708-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	201050-001	Jul 16, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	204522-001	Jan 24, 2017	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	215600-001	May 8, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	PHENOXYBENZAMINE HYDROCHLORIDE	phenoxybenzamine hydrochloride	CAPSULE;ORAL	212568-001	Oct 27, 2020	AB	RX	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:	7
NDAs:	7
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	7
Patent Applications:	936
What excipients (inactive ingredients) are in phenoxybenzamine hydrochloride?	phenoxybenzamine hydrochloride excipients list
DailyMed Link:	phenoxybenzamine hydrochloride at DailyMed

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists