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Last Updated: November 22, 2024

HALOPERIDOL DECANOATE - Generic Drug Details


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

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
Drug Prices for HALOPERIDOL DECANOATE

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Drug Sales Revenue Trends for HALOPERIDOL DECANOATE

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Recent Clinical Trials for HALOPERIDOL DECANOATE

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SponsorPhase
National Institutes of Health (NIH)Phase 3
National Institute of Mental Health (NIMH)Phase 3
Case Western Reserve UniversityPhase 3

See all HALOPERIDOL DECANOATE clinical trials

Pharmacology for HALOPERIDOL DECANOATE
Anatomical Therapeutic Chemical (ATC) Classes for HALOPERIDOL DECANOATE

US Patents and Regulatory Information for HALOPERIDOL DECANOATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mankind Pharma HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 216730-001 May 23, 2023 AO RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 076463-001 Jun 24, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 076463-002 Jun 24, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fresenius Kabi Usa HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 074893-002 Dec 19, 1997 AO RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Labs Ltd HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 075440-002 Feb 28, 2000 AO RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 214507-001 Jul 26, 2021 AO RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 075176-001 Feb 9, 2000 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

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