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Last Updated: April 20, 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 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.

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

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

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

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
Mylan Labs Ltd HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 075440-001 Feb 28, 2000 AO RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 076463-001 Jun 24, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mankind Pharma HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 216730-001 May 23, 2023 AO RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Somerset Theraps Llc HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 209101-001 Jul 3, 2018 AO RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mankind Pharma HALOPERIDOL DECANOATE haloperidol decanoate INJECTABLE;INJECTION 216730-002 May 23, 2023 AO RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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