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Last Updated: August 7, 2020

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Haloperidol lactate - Generic Drug Details

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

Haloperidol lactate is the generic ingredient in four branded drugs marketed by Ortho Mcneil, Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, SCS, Teva, Teva Pharms, Hikma, Janssen Pharms, Abraxis Pharm, Akorn, Baxter Hlthcare Corp, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Smith And Nephew, Solopak, Teva Pharms Usa, Watson Labs, West-ward Pharms Int, and Actavis Mid Atlantic, and is included in thirty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for haloperidol lactate. Fourteen suppliers are listed for this compound.

Summary for haloperidol lactate
Drug Sales Revenue Trends for haloperidol lactate

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Recent Clinical Trials for haloperidol lactate

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

SponsorPhase
Services Institute of Medical Sciences, PakistanPhase 1
Haining Health-Coming Biotech Co., Ltd.Phase 2
University Hospital, Basel, SwitzerlandPhase 4

See all haloperidol lactate clinical trials

Pharmacology for haloperidol lactate

US Patents and Regulatory Information for haloperidol lactate

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 haloperidol lactate INJECTABLE;INJECTION 075689-001 Mar 9, 2001 AP RX No No   Start Trial   Start Trial   Start Trial
Actavis Mid Atlantic HALOPERIDOL LACTATE haloperidol lactate SOLUTION;ORAL 074536-001 Nov 2, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 070714-001 May 17, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Marsam Pharms Llc HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 072517-001 Feb 25, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int HALOPERIDOL haloperidol lactate INJECTABLE;INJECTION 075858-001 Jun 18, 2001 AP RX No No   Start Trial   Start Trial   Start Trial
Pharm Assoc HALOPERIDOL haloperidol lactate CONCENTRATE;ORAL 073037-001 Feb 26, 1993 AA RX No Yes   Start Trial   Start Trial   Start Trial
>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 lactate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ortho Mcneil HALDOL haloperidol lactate CONCENTRATE;ORAL 015922-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Janssen Pharms HALDOL haloperidol lactate INJECTABLE;INJECTION 015923-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Merck
Colorcon
Medtronic
AstraZeneca

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