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Last Updated: August 10, 2020

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HALDOL Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Haldol

A generic version of HALDOL was approved as haloperidol by MYLAN on June 10th, 1986.

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Drug patent expirations by year for HALDOL
Drug Prices for HALDOL

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Recent Clinical Trials for HALDOL

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SponsorPhase
M.D. Anderson Cancer CenterPhase 2/Phase 3
National Cancer Institute (NCI)Phase 2/Phase 3
Zuyderland Medisch CentrumPhase 4

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Pharmacology for HALDOL

US Patents and Regulatory Information for HALDOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ortho Mcneil HALDOL haloperidol lactate CONCENTRATE;ORAL 015922-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-003 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms HALDOL haloperidol decanoate INJECTABLE;INJECTION 018701-002 Jan 31, 1997 AO RX Yes Yes   Start Trial   Start Trial   Start Trial
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-004 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Janssen Pharms HALDOL haloperidol lactate INJECTABLE;INJECTION 015923-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Pharms HALDOL haloperidol decanoate INJECTABLE;INJECTION 018701-001 Jan 14, 1986 AO RX Yes Yes   Start Trial   Start Trial   Start Trial
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-002 Approved Prior to Jan 1, 1982 DISCN Yes No   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 HALDOL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Ortho Mcneil HALDOL haloperidol lactate CONCENTRATE;ORAL 015922-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-005 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-006 Feb 2, 1982   Start Trial   Start Trial
Janssen Pharms HALDOL haloperidol lactate INJECTABLE;INJECTION 015923-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Ortho Mcneil HALDOL haloperidol TABLET;ORAL 015921-002 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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