HALDOL Drug Patent Profile

Which patents cover Haldol, and what generic alternatives are available?

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Haldol

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

Summary for HALDOL

US Patents:	0
Applicants:	3
NDAs:	5
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	46
Patent Applications:	912
Drug Prices:	Drug price information for HALDOL
What excipients (inactive ingredients) are in HALDOL?	HALDOL excipients list
DailyMed Link:	HALDOL at DailyMed

See drug prices for HALDOL

Recent Clinical Trials for HALDOL

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

See all HALDOL clinical trials

Pharmacology for HALDOL

Drug Class

Typical Antipsychotic

US Patents and Regulatory Information for HALDOL

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
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Janssen Pharms	HALDOL	haloperidol decanoate	INJECTABLE;INJECTION	018701-002	Jan 31, 1997		DISCN	Yes	No
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Janssen Pharms	HALDOL	haloperidol lactate	INJECTABLE;INJECTION	015923-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for HALDOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-002	Approved Prior to Jan 1, 1982
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-004	Approved Prior to Jan 1, 1982
Ortho Mcneil	HALDOL	haloperidol lactate	CONCENTRATE;ORAL	015922-001	Approved Prior to Jan 1, 1982
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-001	Approved Prior to Jan 1, 1982
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-005	Approved Prior to Jan 1, 1982

International Patents for HALDOL

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	895309

DrugChatter Q&A for HALDOL

Haldol drug classification?
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