HALOPERIDOL DECANOATE - Generic Drug Details

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

Haloperidol decanoate is the generic ingredient in two branded drugs marketed by Janssen Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Mylan Labs Ltd, Sandoz Inc, Somerset Theraps Llc, Teva Pharms Usa, and Zydus Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for haloperidol decanoate. Thirteen suppliers are listed for this compound.

Sponsor	Phase
National Institutes of Health (NIH)	Phase 3
National Institute of Mental Health (NIMH)	Phase 3
Case Western Reserve University	Phase 3

Sponsor

Phase

National Institutes of Health (NIH)

Phase 3

National Institute of Mental Health (NIMH)

Phase 3

Case Western Reserve University

Phase 3

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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
Mylan Labs Ltd	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	075440-002	Feb 28, 2000	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	075393-001	May 11, 1999	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	214507-001	Jul 26, 2021	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	075176-001	Feb 9, 2000		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	HALDOL	haloperidol decanoate	INJECTABLE;INJECTION	018701-001	Jan 14, 1986	AO	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz Inc	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	076463-001	Jun 24, 2005		DISCN	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:	11
NDAs:	12
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	8
Patent Applications:	337
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for HALOPERIDOL DECANOATE
What excipients (inactive ingredients) are in HALOPERIDOL DECANOATE?	HALOPERIDOL DECANOATE excipients list
DailyMed Link:	HALOPERIDOL DECANOATE at DailyMed