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PROZAC

NDA

FLUOXETINE HYDROCHLORIDE | N020974 | ELI LILLY AND CO

2 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Lachman Consultant Services, Inc. FDA-2000-P-0414 · 4 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Prozac (Fluoxetine) Tablets, 20 mg (NDA-20-974), manufactured by Eli Lilly and Company, was voluntarily withdrawn or withheld from sale for safety or effectiveness reasons pursuant to 21 CFR 314.161 and 3	505(q)	2017-05-22	Granted	Lachman Consultant Services, Inc.
Citizen Petition from Public Citizen Health Research Group (HRG) FDA-1991-P-0352 · 4 docket documents Public Citizen Health Research Group filed this citizen petition on May 23, 1991, requesting that the FDA immediately revise the approved labeling for fluoxetine (Prozac, manufactured by Eli Lilly and Company) to include a boxed warning regarding its association with intense, violent suicidal preocc	Other	2014-03-17	Denied	Public Citizen Health Research Group (HRG)

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

Clinical Trials

105 trials from ClinicalTrials.gov — 2 recruiting, 74 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
The Effects of Fluoxetine and/or DHEA NCT03228732	Early Phase 1	Recruiting	University of Maryland, Baltimore	60	2017-12-19 → 2026-12-15
Pharmaco(Epi)Genetic, Proteomic, and Microbiomic Study of Obsessive-Compulsive Disorder NCT02431845	N/A	Recruiting	Severance Hospital	200	2013-01-01 → 2030-12-31
NMDA Antagonists in Bipolar Depression NCT01833897	Phase 4	Completed	New York State Psychiatric Institute	8	2013-03 → 2016-03
Treatment of Adolescent Suicide Attempters (TASA)NCT00080158	Phase 2/3	Completed	New York State Psychiatric Institute	120	2004-03 → 2007-06
Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder NCT00797966	Phase 2	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.	850	2009-05 → 2010-07
Bioequivalence Study of Fluoxetine Hydrochloride Delayed-Release Capsules 90 mg of Dr. Reddy's Under Fed Condition NCT01166087	Phase 1	Completed	Dr. Reddy's Laboratories Limited	54	2006-02 → 2006-09
90 mg Fluoxetine Hydrochloride Capsules Under Fasting Conditions NCT01247272	Phase 1	Completed	Teva Pharmaceuticals USA	26	2001-05 → 2001-07
A Study in the Treatment of Children and Adolescents With Major Depressive Disorder NCT00849693	Phase 3	Completed	Eli Lilly and Company	463	2009-03 → 2011-09
Brain Imaging Techniques That Predict Antidepressant Responsiveness NCT00909155	N/A	Completed	University of Wisconsin, Madison	50	2002-07 → 2009-12
To Demonstrate the Relative Bioavailability of Geneva and Dista (Prozac) 20 mg Fluoxetine Hydrochloride Capsules (Pulvules) In Healthy Adult Males Under Fed and Fasted Conditions NCT00913588	Phase 1	Completed	Sandoz	24	1996-05 → 1996-08

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

API Supply Chain13 active DMFs10 inactive

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

OLON SPAFLUOXETINE HYDROCHLORIDE

DMF 86951990

ERREGIERRE SPAFLUOXETINE HYDROCHLORIDE USP-EP

DMF 108371994

FERMION OYFLUOXETINE HYDROCHLORIDE USP

DMF 113151995

OLON SPAFLUOXETINE HYDROCHLORIDE

DMF 120091996

QUIMICA SINTETICA SAFLUOXETINE HYDROCHLORIDE

DMF 122911996

DR REDDYS LABORATORIES LTDFLUOXETINE HYDROCHLORIDE USP

DMF 130691998

CADILA PHARMACEUTICALS LTDFLUOXETINE HYDROCHLORIDE USP

DMF 142531999

APITORIA PHARMA PRIVATE LTDFLUOXETINE HYDROCHLORIDE USP

DMF 189802005

SIEGFRIED LTDFLUOXETINE HYDROCHLORIDE

DMF 217682008

ALEMBIC PHARMACEUTICALS LTDFLUOXETINE HYDROCHLORIDE USP

DMF 257782012

APITORIA PHARMA PRIVATE LTDFLUOXETINE HYDROCHLORIDE USP (PROCESS II)

DMF 339402019

IPCA LABORATORIES LTDFLUOXETINE HYDROCHLORIDE USP

DMF 409692024

CHEMECA DRUGS PRIVATE LTDFLUOXETINE HYDROCHLORIDE USP

DMF 426682025

LILLY RESEARCH LABORATORIES DIV ELI LILLY AND COInactiveFLUOXETINE HYDROCHLORIDE, BULK

DMF 46731982

NATCO PHARMA LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 119921996

INDUSTRIALE CHIMICA SRLInactiveFLUOXETINE HYDROCHLORIDE

DMF 122921996

SIEGFRIED LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 124371997

UNION QUIMICO FARMACEUTICA SAInactiveFLUOXETINE HYDROCHLORIDE, USP

DMF 126311997

BASF PHARMACHEMIKALIEN GMBH CO KGInactiveFLUOXETINE HYDROCHLORIDE

DMF 130261998

WOCKHARDT LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 142891999

RANBAXY LABORATORIES LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 153622001

WOCKHARDT LTDInactiveFLUOXETINE HYDROCHLORIDE USP

DMF 181772005

CHANGZHOU SIYAO PHARMACEUTICALS CO LTDInactiveFLUOXETINE HYDROCHLORIDE

DMF 199802006

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Apr 13, 2006	SUPPL -7	View Letter (PDF)
Dec 5, 2005	SUPPL -5	View Letter (PDF)
Feb 23, 2005	SUPPL -6	View Letter (PDF)
Aug 25, 2004	SUPPL -4	View Letter (PDF)
Mar 9, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 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: Mar 9, 1999

No patent or exclusivity listings for this strength.

#002 — EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 9, 1999