Haloperidol decanoate - Generic Drug Details

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

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

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

Summary for haloperidol decanoate

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	13
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	8
Patent Applications:	339
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

See drug prices for haloperidol decanoate

Drug Sales Revenue Trends for haloperidol decanoate

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Recent Clinical Trials for haloperidol decanoate

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

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

See all haloperidol decanoate clinical trials

Pharmacology for haloperidol decanoate

Drug Class	Typical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for haloperidol decanoate

N05AD	Butyrophenone derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for haloperidol decanoate

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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
Meitheal	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	214507-001	Jul 26, 2021	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	211180-001	Oct 22, 2019	AO	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mankind Pharma	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	216730-002	May 23, 2023	AO	RX	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

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