FLUPHENAZINE DECANOATE - Generic Drug Details

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

Fluphenazine decanoate is the generic ingredient in two branded drugs marketed by Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Mylan Labs Ltd, Teva Parenteral, and Bristol Myers Squibb, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for fluphenazine decanoate. Eight suppliers are listed for this compound.

Sponsor	Phase
Tufts Medical Center	Phase 2
Immune Control	Phase 2
National Institute of Mental Health (NIMH)	Phase 4

Sponsor

Phase

Tufts Medical Center

Phase 2

Immune Control

Phase 2

National Institute of Mental Health (NIMH)

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
Gland Pharma Ltd	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	215509-001	Mar 30, 2023	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Parenteral	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	074795-001	Sep 10, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	074966-001	Apr 16, 1998		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	207739-001	Oct 17, 2017	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bristol Myers Squibb	PROLIXIN DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	016727-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	071413-001	Jul 14, 1987	AO	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:	10
NDAs:	10
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	2
Patent Applications:	3,080
Drug Prices:	Drug price trends for FLUPHENAZINE DECANOATE
What excipients (inactive ingredients) are in FLUPHENAZINE DECANOATE?	FLUPHENAZINE DECANOATE excipients list
DailyMed Link:	FLUPHENAZINE DECANOATE at DailyMed