HALOPERIDOL - Generic Drug Details

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

Haloperidol is the generic ingredient in six branded drugs marketed by Ortho Mcneil, Ortho Mcneil Pharm, Actavis Group, Aiping Pharm Inc, Chartwell Rx, Duramed Pharms Barr, Innogenix, Lederle, 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, Mankind Pharma, 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-one suppliers are listed for this compound.

Summary for HALOPERIDOL

US Patents:	0
Tradenames:	6
Applicants:	48
NDAs:	112
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	217
Patent Applications:	6,796
Formulation / Manufacturing:	see details
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

See drug sales revenues for HALOPERIDOL

Recent Clinical Trials for HALOPERIDOL

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

Sponsor	Phase
Christian Hassager	Phase 3
Qilu Pharmaceutical Co., Ltd.	Phase 3
Cancer Prevention Research Institute of Texas	Phase 2/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

US Patents and Regulatory Information for HALOPERIDOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	074893-002	Dec 19, 1997	AO	RX	No	No
Msn	HALOPERIDOL	haloperidol	TABLET;ORAL	216004-006	Nov 18, 2022	AB	RX	No	No
Innogenix	HALOPERIDOL	haloperidol	TABLET;ORAL	071173-004	Jan 2, 1987	AB	RX	No	No
Hikma	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	075305-001	Sep 28, 1998	AO	RX	No	No

Expired US Patents for HALOPERIDOL

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
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-001	Approved Prior to Jan 1, 1982
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-006	Feb 2, 1982
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-004	Approved Prior to Jan 1, 1982