Haloperidol - Generic Drug Details

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

Haloperidol is the generic ingredient in six branded drugs marketed by Ortho Mcneil, Ortho Mcneil Pharm, Actavis Group, Aiping Pharm Inc, Aurobindo Pharma Ltd, Chartwell Rx, Duramed Pharms Barr, Innogenix, Lederle, Mankind Pharma, MSN, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, Sciegen Pharms Inc, SCS, Strides Pharma, Upsher Smith Labs, Watson Labs, Zydus Pharms Usa, Janssen Pharms, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, Zydus Pharms, Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon, Teva, Teva Pharms, Abraxis Pharm, Baxter Hlthcare Corp, Epic Pharma Llc, Fosun Pharma, Marsam Pharms Llc, Sagent Pharms, Smith And Nephew, Solopak, and Actavis Mid Atlantic, and is included in one hundred and twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for haloperidol. Twenty-three suppliers are listed for this compound.

Summary for haloperidol

US Patents:	0
Tradenames:	6
Applicants:	49
NDAs:	112
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	219
Patent Applications:	7,034
Drug Prices:	Drug price trends for haloperidol
Drug Sales Revenues:	Drug sales revenues for haloperidol
What excipients (inactive ingredients) are in haloperidol?	haloperidol excipients list
DailyMed Link:	haloperidol at DailyMed

See drug prices for haloperidol

Drug Sales Revenue Trends for haloperidol

See drug sales revenues for haloperidol

Recent Clinical Trials for haloperidol

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

Sponsor	Phase
Assiut University	Phase 4
Christian Hassager	Phase 3
Qilu Pharmaceutical Co., Ltd.	Phase 3

See all haloperidol clinical trials

Pharmacology for haloperidol

Drug Class	Typical Antipsychotic

Medical Subject Heading (MeSH) Categories for haloperidol

Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Dopamine Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for haloperidol

N05AD	Butyrophenone derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for haloperidol

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Glossary

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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
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 lactate	INJECTABLE;INJECTION	015923-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Group	HALOPERIDOL	haloperidol	TABLET;ORAL	200854-003	Jul 1, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Royce Labs	HALOPERIDOL	haloperidol	TABLET;ORAL	071722-001	Dec 24, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Mid Atlantic	HALOPERIDOL LACTATE	haloperidol lactate	SOLUTION;ORAL	074536-001	Nov 2, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	HALOPERIDOL	haloperidol lactate	CONCENTRATE;ORAL	071617-001	Dec 1, 1988		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

Expired US Patents for haloperidol

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-001	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	TABLET;ORAL	015921-005	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-006	Feb 2, 1982	⤷ Sign Up	⤷ Sign Up
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-003	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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