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Generated: October 21, 2018

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FLUOXETINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for fluoxetine hydrochloride and what is the scope of fluoxetine hydrochloride patent protection?

Fluoxetine hydrochloride is the generic ingredient in eight branded drugs marketed by Barr, Dr Reddys Labs Ltd, Lilly, Sun Pharm Industries, Watson Labs, Alembic Pharms Ltd, Ani Pharms Inc, Aurobindo Pharma, Carlsbad, Cr Double Crane, Heritage Pharms Inc, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Mylan, Mylan Pharms Inc, Par Pharm, Sandoz, Sciegen Pharms Inc, Specgx Llc, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Wockhardt Ltd, Eli Lilly And Co, Actavis Mid Atlantic, Apotex Inc, Aurobindo Pharma Ltd, Hi Tech Pharma, Lannett Co Inc, Pharm Assoc, Wockhardt Bio Ag, Alvogen, Fosun Pharma, Inventia Hlthcare, Par Form, Par Pharm Inc, Torrent Pharms Ltd, Apil, and Teva Pharms, and is included in sixty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for fluoxetine hydrochloride. Seventy-two suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for FLUOXETINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for FLUOXETINE HYDROCHLORIDE
Synonyms for FLUOXETINE HYDROCHLORIDE
(+-)-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
(+/-)-FLUOXETINE 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
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
AK163170
AKOS015894939
Alental
Alzac 20
AN-14688
AN-40216
ANW-42507
Apo-Fluoxentine
BC208532
BENZENEPROPANAMINE, N-METHYL-G-[4-(TRIFLUOROMETHYL)PHENOXY]-, HYDROCHLORIDE (1:1)
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
DR001730
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 (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; traceable to USP, PhEur and BP
Fluoxetine hydrochloride, solid
Fluoxetine hydrochloride, United States Pharmacopeia (USP) Reference Standard
Fluoxetine hydrochloride, VETRANAL(TM), analytical standard
Fluoxetine hydrochoride
Fluoxetine, Hydrochloride
Fluoxetine.HCl
FluoxetineHydrochloride
Fluoxifar
Fluoxil
Flutin
Flutine
Fluxen
Fluxene
Fluxil
Fondur
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)AMINE HYDROCHLORIDE
Methyl(3-phenyl-3-(4-(trifluoromethyl)phenoxy)propyl)ammonium chloride
METHYL(3-PHENYL-3-[4-(TRIFLUOROMETHYL)PHENOXY]PROPYL)AMINE, 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]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
OR162195
OR206941
Oxedep
Pharmakon1600-01504173
Pragmaten
Prestwick_798
Prizma
Proctin
Prodep
Profluzac
Propylamine, N-methyl-3-phenyl-3-(p-trifluoromethylphenoxy)-, hydrochloride
Prozac
Prozac (TN)
Prozac 20
Prozac; LY-110,140 hydrochloride
Prozac;Sarafem
PROZAC(R) HYDROCHLORIDE
Psipax
Reconcile
RL04127
Rowexetina
s1333
SAM002589965
Sanzur
Sarafem
Saurat
SBB066066
SC-12129
SC-53387
SCHEMBL33384
Selfemra
Seronil
Sinzac
Siquial
SMR000058452
SPECTRUM1504173
SR-01000002988
SR-01000002988-2
ST24047216
Tox21_200182
Tox21_500558
TRA-0205161
TRA0057937
TRA0075235
Tuneluz
Verotina
Z1741982921
Zactin
Zedprex
Zepax
Tentative approvals for FLUOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign UpEQ 40MG BASECAPSULE;ORAL
➤ Sign Up➤ Sign UpEQ 20MG BASECAPSULE;ORAL
➤ Sign Up➤ Sign UpEQ 10MG BASECAPSULE;ORAL

US Patents and Regulatory Information for FLUOXETINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic Pharms Ltd FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 208698-001 Apr 5, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Alvogen FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 202133-001 Oct 6, 2011 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly SYMBYAX fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 021520-004 Dec 24, 2003 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 075755-001 Aug 2, 2001 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Inventia Hlthcare FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 209695-001 Nov 20, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly PROZAC WEEKLY fluoxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021235-001 Feb 26, 2001 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly SYMBYAX fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 021520-003 Dec 24, 2003 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for FLUOXETINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eli Lilly And Co SARAFEM fluoxetine hydrochloride CAPSULE;ORAL 018936-007 Jul 6, 2000 ➤ Sign Up ➤ Sign Up
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-006 Dec 23, 1992 ➤ Sign Up ➤ Sign Up
Eli Lilly And Co SARAFEM fluoxetine hydrochloride CAPSULE;ORAL 018936-008 Jul 6, 2000 ➤ Sign Up ➤ Sign Up
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987 ➤ Sign Up ➤ Sign Up
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987 ➤ Sign Up ➤ Sign Up
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987 ➤ Sign Up ➤ Sign Up
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Moodys
Merck
Fish and Richardson
Federal Trade Commission
McKesson
Baxter
Covington
Fuji

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