Fluphenazine decanoate - Generic Drug Details

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What are the generic sources for fluphenazine decanoate and what is the scope of patent protection?

Fluphenazine decanoate is the generic ingredient in two branded drugs marketed by Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, MSN, Mylan Labs Ltd, Par Sterile Products, 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
Immune Control	Phase 2
Tufts Medical Center	Phase 2
National Institute of Mental Health (NIMH)	Phase 4

Sponsor

Phase

Immune Control

Phase 2

Tufts Medical Center

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
Par Sterile Products	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	203732-001	Jul 3, 2014	AO	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Eugia Pharma	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	207739-001	Oct 17, 2017	AO	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Labs Ltd	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	075918-001	Aug 17, 2001	AO	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Parenteral	FLUPHENAZINE DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	074795-001	Sep 10, 1996		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bristol Myers Squibb	PROLIXIN DECANOATE	fluphenazine decanoate	INJECTABLE;INJECTION	016727-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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:	3,307
Formulation / Manufacturing:	see details
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