HALDOL Drug Patent Profile

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Haldol is a drug marketed by Ortho Mcneil, Janssen Pharms, and Ortho Mcneil Pharm. and is included in five NDAs.

The generic ingredient in HALDOL is haloperidol. There are twenty drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the haloperidol profile page.

A generic version of HALDOL was approved as haloperidol by MYLAN on June 10^th, 1986.

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	46
Patent Applications:	3,828
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for HALDOL
What excipients (inactive ingredients) are in HALDOL?	HALDOL excipients list
DailyMed Link:	HALDOL at DailyMed

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Western Michigan University School of Medicine	Phase 4
Zuyderland Medisch Centrum	Phase 4
National Institutes of Health (NIH)	Phase 2/Phase 3

Drug Class	Typical Antipsychotic

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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
Ortho Mcneil	HALDOL	haloperidol lactate	CONCENTRATE;ORAL	015922-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Janssen Pharms	HALDOL	haloperidol decanoate	INJECTABLE;INJECTION	018701-002	Jan 31, 1997	AO	RX	Yes	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-004	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ortho Mcneil	HALDOL	haloperidol lactate	CONCENTRATE;ORAL	015922-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

See the table below for patents covering HALDOL around the world.

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Country	Patent Number	Title	Estimated Expiration
United Kingdom	895309		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration