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COMPAZINE

NDA

PROCHLORPERAZINE MALEATE | N010571 | GLAXOSMITHKLINE

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consulting Services, Inc. FDA-2020-P-0598 · 5 docket documents Lachman Consulting Services, Inc. filed this petition requesting the FDA designate Prochlorperazine Maleate Tablets USP, 10 mg (A040268) of Jubilant Cadista Pharmaceuticals Inc. as a reference standard, or a suitable alternative reference standard, for in vivo bioequivalence studies to support an AN	505(q)	2020-02-04	Withdrawn	Lachman Consulting Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

23 trials from ClinicalTrials.gov, 15 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
TRC102 and Temozolomide for Relapsed Solid Tumors and Lymphomas NCT01851369	Phase 1/2	Completed	National Cancer Institute (NCI)	93	2013-07-12 → 2023-08-01
Staccato Prochlorperazine Thorough QT/QTc NCT00543062	Phase 1	Completed	Alexza Pharmaceuticals, Inc.	48	2007-10 → 2007-12
Hydromorphone Versus Prochlorperazine + Diphenhydramine for Acute Migraine NCT02389829	Phase 4	Completed	Montefiore Medical Center	127	2015-03 → 2016-10
Sunitinib or Cediranib for Alveolar Soft Part Sarcoma NCT01391962	Phase 2	Completed	National Cancer Institute (NCI)	34	2011-07-18 → 2026-01-16
Prevention of Delayed Nausea A Phase III Double-Blind Placebo-Controlled Clinical Trial NCT00475085	Phase 3	Completed	Joseph Roscoe	1,021	2006-12
Staccato Prochlorperazine in Migraine (in Clinic)NCT00610428	Phase 2	Completed	Alexza Pharmaceuticals, Inc.	75	2005-03 → 2005-10
Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer NCT03367572	Phase 3	Completed	University of Rochester NCORP Research Base	1,363	2018-04-19 → 2024-04-13
Comparison of Antiemetic Drugs in Preventing Delayed Nausea After Chemotherapy in Patients With Cancer NCT00020657	Phase 3	Completed	Gary Morrow	—	2001-07 → 2004-10
Intravenous Fluids in Benign Headaches Trial NCT03185130	Phase 4	Completed	University Medical Center of Southern Nevada	58	2017-05-16 → 2019-05-15
Staccato Prochlorperazine Single Dose PK Study NCT00610727	Phase 1	Completed	Nova Pneuma Inc.	54	2004-08 → 2004-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain3 active DMFs4 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

TRIFARMA SPAPROCHLORPERAZINE MALEATE

DMF 23681974

BIOPHORE INDIA PHARMACEUTICALS PVT LTDPROCHLORPERAZINE MALEATE

DMF 318422017

RAKS PHARMA PVT LTDPROCHLORPERAZINE MALEATE USP

DMF 361732021

INDUSTRIA CHIMICA MILANESE SPAInactivePROCHLORPERAZINE MALEATE

DMF 4681962

PHENCHEM INDUSTRIES LTDInactivePROCHLORPERAZINE MALEATE

DMF 25931976

CYCLO PRODUCTS INCInactivePROCHLORPERAZINE MALEATE U.S.P.

DMF 30781977

EGIS PHARMACEUTICALS PRIVATE LTDInactivePROCHLORPERAZINE MALEATE

DMF 93641991

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 8, 2005	SUPPL -96	View Letter (PDF)
Apr 3, 2001	SUPPL -95	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#003 — EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982