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Last Updated: December 8, 2019

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PROZAC Drug Profile

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When do Prozac patents expire, and what generic alternatives are available?

Prozac is a drug marketed by Eli Lilly And Co and Lilly and is included in four NDAs.

The generic ingredient in PROZAC is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.

Drug patent expirations by year for PROZAC
Drug Prices for PROZAC

See drug prices for PROZAC

Drug Sales Revenue Trends for PROZAC

See drug sales revenues for PROZAC

Recent Clinical Trials for PROZAC

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

SponsorPhase
Azienda Ospedaliera Universitaria Integrata VeronaPhase 4
University of CataniaPhase 4
Dalhousie UniversityPhase 2

See all PROZAC clinical trials

Recent Litigation for PROZAC

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
Hawthorne v. Eli Lilly And Company2011-12-07
ELI LILLY AND COMPANY v. TEVA PARENTERAL MEDICINES, INC.2010-10-29

See all PROZAC litigation

Pharmacology for PROZAC
Synonyms for PROZAC
(+-)-Methyl-gamma-(4-(trifluoromethyl)phenoxy)benzenepropanamine hydrochloride
(+-)-N-Methyl-3-phenyl-3-((alpha,alpha,alpha-trifluoro-p-tolyl)oxy)propylamine, hydrochloride
(+-)-N-Methyl-3-phenyl-3-(4-(trifluoromethyl)phenoxy)propylamine hydrochloride
(+/-)-N-Methyl-3-phenyl-3-[(alpha,alpha,alpha-trifluoro-p-tolyl)oxy]propylamine, HCl
(+/-)-N-Methyl-gamma-[4-(trifluoromethyl)phenoxy]benzenepropanamine hydrochloride
(S)-N-Methyl-3-phenyl-3-(4-(trifluoromethyl)phenoxy)propan-1-amine
100568-02-3
3-(p-Trifluoromethylphenoxy)-N-methyl-3-phenylpropylamine hydrochloride
54910-89-3 (Parent)
56296-78-7
59333-67-4
910F893
AB04860
AB2000053
AC-1697
AC1L1XXD
Adofen
Affectine
AKOS015894939
Alental
Alzac 20
AN-14688
AN-40216
ANW-42507
Apo-Fluoxentine
BC208532
BCP19962
Benzenepropanamine, N-methyl-gamma-(4-(trifluoromethyl)phenoxy)-, hydrochloride
Benzenepropanamine, N-methyl-gamma-(4-(trifluoromethyl)phenoxy)-, hydrochloride, (+-)-
Bioxetin
C17H18F3NO.HCl
CAS-56296-78-7
CCG-39084
CCRIS 6150
CHEMBL1201082
CPD000058452
Cramin
CS-1838
CTK8B3427
D00823
Depreks
Deproxin
Digassim
dl-N-Methyl-3-(p-trifluoromethylphenoxy)-3-phenylpropylamine, HCl
DSSTox_CID_635
DSSTox_GSID_20635
DSSTox_RID_75706
DTXSID7020635
EINECS 260-101-2
Equilibrane
Erocap
EU-0100558
F-132
F0750
Felicium
Fluctin
Fluctine
Fludac
Fludeka
Flufran
Fluneurin
Flunil
Flunirin
Fluox-Puren
Fluoxac
Fluoxeren
Fluoxetin HCl
Fluoxetine HCl
Fluoxetine (hydrochloride)
Fluoxetine Hcl
FLUOXETINE HYDROCHLORIDE
Fluoxetine hydrochloride (JAN/USP)
Fluoxetine hydrochloride [USAN:USP]
Fluoxetine hydrochloride [USAN]
Fluoxetine Hydrochloride 1.0 mg/ml in Methanol (as free base)
Fluoxetine hydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Fluoxetine hydrochloride, British Pharmacopoeia (BP) Reference Standard
Fluoxetine hydrochloride, European Pharmacopoeia (EP) Reference Standard
Fluoxetine Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Fluoxetine hydrochloride, solid
Fluoxetine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Fluoxetine hydrochloride, VETRANAL(TM), analytical standard
Fluoxetine hydrochoride
Fluoxetine, HCl
Fluoxetine, Hydrochloride
Fluoxetine.HCl
FluoxetineHydrochloride
Fluoxifar
Fluoxil
Flutin
Flutine
Fluxen
Fluxene
Fluxil
Fondur
Fontex
Fonzac
Foxetin
Framex
FT-0626490
FT-0652216
GIYXAJPCNFJEHY-UHFFFAOYSA-N
HMS1569H03
HMS1922F07
HSDB 6633
HY-B0102A
I06-0079
I06-079
IN1336
J-521372
J10277
KM0299
KS-00000JJ6
KS-1061
Lilly 110140
Lorien
Lovan
LP00558
LS-185085
LS-31041
LS-7403
LY 110140
LY-110,140 hydrochloride
LY-110140
LY110140
Margrilan
methyl({3-phenyl-3-[4-(trifluoromethyl)phenoxy]propyl})amine hydrochloride
Methyl(3-phenyl-3-(4-(trifluoromethyl)phenoxy)propyl)ammonium chloride
MFCD00214288
Mitilase
MLS000069361
MLS001076338
MLS002222264
Modipran
MolPort-003-666-535
Motivone
Mutan
Mutin
N-METHYL-3-[(4-TRIFLUOROMETHYL)PHENOXY]-3-PHENYLPROPYLAMINE HYDROCHLORIDE
N-methyl-3-phenyl-3-(4-(trifluoromethyl)phenoxy)propan-1-amine hydrochloride
N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]-1-propanamine hydrochloride (1:1)
N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]-1-propylamine Hydrochloride
N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine hydrochloride
N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine;hydrochloride
N-methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propan-1-amine;hydrochloride.
N-Methyl-3-phenyl-3-[4-(trifluoromethyl)phenoxy]propylamine Hydrochloride
N-methyl-3-phenyl-3-{[4-(trifluoromethyl)phenyl]oxy}propan-1-amine hydrochloride
NC00715
NCGC00093943-01
NCGC00093943-02
NCGC00093943-03
NCGC00093943-04
NCGC00093943-05
NCGC00257736-01
NCGC00261243-01
Neupax
Nopres
NPL-2008
NSC-714457
NSC-758685
NSC714457
NSC758685
Nuzak
Nycoflox
Opera_ID_1538
Oxedep
Pharmakon1600-01504173
Pragmaten
Prestwick_798
Prizma
Proctin
Prodep
Profluzac
Propylamine, N-methyl-3-phenyl-3-(p-trifluoromethylphenoxy)-, hydrochloride
Prozac (TN)
Prozac 20
Prozac Weekly
Prozac; LY-110,140 hydrochloride
Prozac;Sarafem
Psipax
Reconcile
RL04127
Rowexetina
s1333
SAM002589965
Sanzur
Sarafem
Saurat
SC-12129
SC-53387
SCHEMBL33384
Selfemra
Seronil
Sinzac
Siquial
SMR000058452
SPECTRUM1504173
SR-01000002988
SR-01000002988-2
SR-01000002988-4
SR-01000002988-9
ST24047216
SW196934-4
Tox21_200182
Tox21_500558
TRA-0205161
TRA0057937
TRA0075235
Tuneluz
Verotina
Z1741982921
Zactin
Zedprex
Zepax
Paragraph IV (Patent) Challenges for PROZAC
Tradename Dosage Ingredient NDA Submissiondate
PROZAC TABLET;ORAL fluoxetine hydrochloride 020974
PROZAC CAPSULE;ORAL fluoxetine hydrochloride 018936
SARAFEM CAPSULE;ORAL fluoxetine hydrochloride 018936
PROZAC SOLUTION;ORAL fluoxetine hydrochloride 020101

US Patents and Regulatory Information for PROZAC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-006 Dec 23, 1992 AB1 RX Yes No   Start Trial   Start Trial   Start Trial
Lilly PROZAC fluoxetine hydrochloride TABLET;ORAL 020974-002 Mar 9, 1999 DISCN Yes No   Start Trial   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-004 Jun 15, 1999 DISCN No No   Start Trial   Start Trial   Start Trial
Lilly PROZAC WEEKLY fluoxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021235-001 Feb 26, 2001 DISCN Yes No   Start Trial   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987 AB1 RX 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 PROZAC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly PROZAC fluoxetine hydrochloride TABLET;ORAL 020974-002 Mar 9, 1999   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-004 Jun 15, 1999   Start Trial   Start Trial
Lilly PROZAC fluoxetine hydrochloride TABLET;ORAL 020974-001 Mar 9, 1999   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987   Start Trial   Start Trial
Lilly PROZAC fluoxetine hydrochloride SOLUTION;ORAL 020101-001 Apr 24, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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