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PROLIXIN

NDA

FLUPHENAZINE HYDROCHLORIDE | N011751 | APOTHECON INC DIV BRISTOL MYERS SQUIBB

5 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman Phelps & McNamara P.C. FDA-2018-P-0998 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this petition requesting that the FDA determine whether PROLIXIN (fluphenazine HCI) Tablets in strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg, approved under NDA 011751 and held by Apothecon, were withdrawn for reasons of safety or effectiveness, pursuant to sections	505(q)	2018-03-07	Granted	Hyman Phelps & McNamara P.C.
E. R. Squibb & Sons, Inc. - Citizen Petition FDA-1985-P-0231 · 6 docket documents E. R. Squibb & Sons, Inc. filed this citizen petition requesting that the FDA determine fluphenazine hydrochloride injection 5 mg/mL is suitable for an abbreviated new drug application as a product similar and related to the approved NDA 11-751 formulation of fluphenazine hydrochloride injection 2.5	Other	2010-09-17	Denied	—

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

Clinical Trials

9 trials from ClinicalTrials.gov, 6 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Fluphenazine Hydrochloride for Psoriasis NCT00929578	Phase 2	Completed	Tufts Medical Center	15	2008-11 → 2011-01
Fluphenazine in Treating Patients With Refractory Advanced Multiple Myeloma NCT00335647	Phase 1/2	Completed	Immune Control	30	2006-01
D1 and D2 Dopamine Receptors in Gambling and Amphetamine Reinforcement NCT02203786	Phase 2	Completed	Centre for Addiction and Mental Health	60	2009-09 → 2015-09
New Antipsychotic Strategies: Quetiapine and Risperidone vs. Fluphenazine in Treatment Resistant Schizophrenia NCT00161018	Phase 3	Completed	University of Maryland, Baltimore	150	2003-11 → 2004-11
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients NCT02307396	Phase 4	Completed	Technical University of Munich	21	2015-02-01 → 2016-06-22
CATIE- Schizophrenia Trial NCT00014001	Phase 4	Completed	National Institute of Mental Health (NIMH)	1,600	2000-12 → 2004-12
Fluphenazine Decanoate for Psoriasis NCT00356200	Phase 2	Terminated	Tufts Medical Center	10	2006-07 → 2008-09
Pharmacovigilance in Gerontopsychiatric Patients NCT02374567	Phase 3	Terminated	Hannover Medical School	407	2015-01 → 2017-06-28
Study of Fluphenazine in Relapsed or Relapsed-and-Refractory Multiple Myeloma NCT00821301	Phase 1	UNKNOWN	Immune Control	30	2008-12 → 2010-10

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

API Supply Chain8 active DMFs3 inactive

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

FINE CHEMICALS CORP PTY LTDFLUPHENAZINE HYDROCHLORIDE

DMF 56481984

RAKS PHARMA PVT LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 333712018

MSN LIFE SCIENCES PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 337242019

ENALTEC LABS PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 338852019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFLUPHENAZINE HYDROCHLORIDE

DMF 339492019

ALEMBIC PHARMACEUTICALS LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 353662020

AURORE LIFE SCIENCES PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 356952021

CENTAUR PHARMACEUTICALS PRIVATE LTDFLUPHENAZINE HYDROCHLORIDE USP

DMF 363262021

LINSON LTDInactiveFLUPHENAZINE HYDROCHLORIDE, BULK FORM

DMF 43931982

ER SQUIBB AND SONS INCInactiveFLUPHENAZINE HYDROCHLORIDE

DMF 47031982

ORCHIMIE SA (PRODUITS CHIMIQUES ET BIOCHIMIQUES)InactiveFLUPHENAZINE HYDROCHLORIDE

DMF 67151986

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

Products (5)

Sort:

#001 — 2.5MG **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 — 10MG **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 — 5MG **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

#004 — 1MG **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

#005 — 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982