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Last Updated: April 6, 2020

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Fluoxetine hydrochloride - Generic Drug Details

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What are the generic sources for fluoxetine hydrochloride and what is the scope of freedom to operate?

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, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Celltrion, 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, Eli Lilly And Co, Actavis Mid Atlantic, Aurobindo Pharma Ltd, Hi Tech Pharma, Lannett Co Inc, Nostrum Labs Inc, Pharm Assoc, Wockhardt Bio Ag, Alvogen, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Taro, Torrent, Upsher Smith Labs, Apil, and Teva Pharms, and is included in seventy-one NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for fluoxetine hydrochloride

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

SponsorPhase
Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineN/A
Huadong HospitalN/A
Yale UniversityPhase 1

See all fluoxetine hydrochloride clinical trials

Recent Litigation for fluoxetine hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
SEBELA INTERNATIONAL LIMITED v. PRINSTON PHARMACEUTICAL, INC.2017-07-06
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
Hawthorne v. Eli Lilly And Company2011-12-07

See all fluoxetine hydrochloride litigation

Generic filers with tentative approvals for FLUOXETINE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 40MG BASECAPSULE;ORAL
  Start Trial  Start TrialEQ 20MG BASECAPSULE;ORAL
  Start Trial  Start TrialEQ 10MG BASECAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
(+/-)-N-Methyl-&gamma
(+/-)-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
56296-78-7
59333-67-4
910F893
AB04860
AB2000053
AC-1697
Adofen
Affectine
AK163170
AKOS015894939
Alental
Alzac 20
ANW-42507
Apo-Fluoxentine
BCP19962
Benzenepropanamine, N-methyl-gamma-(4-(trifluoromethyl)phenoxy)-, hydrochloride
Benzenepropanamine, N-methyl-gamma-(4-(trifluoromethyl)phenoxy)-, hydrochloride, (+-)-
C17H18F3NO.HCl
CAS-56296-78-7
CCG-39084
CCRIS 6150
CHEBI:145458
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 (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-hydrochloride
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
J-521372
J10277
KM0299
KS-00000JJ6
KS-1061
Lilly 110140
Lilly110140
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
MFCD00214288
Mitilase
MLS000069361
MLS001076338
MLS002222264
Modipran
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
Prozac (TN)
Prozac 20
Prozac Weekly
Prozac; LY-110,140 hydrochloride
Prozac;Sarafem
prozac(r)
Psipax
Q27280620
Reconcile
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 FLUOXETINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
PROZAC TABLET;ORAL fluoxetine hydrochloride 020974
PROZAC CAPSULE;ORAL fluoxetine hydrochloride 018936
PROZAC WEEKLY CAPSULE, DELAYED REL PELLETS;ORAL fluoxetine hydrochloride 021235
SARAFEM CAPSULE;ORAL fluoxetine hydrochloride 018936
PROZAC SOLUTION;ORAL fluoxetine hydrochloride 020101

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
Teva Pharms Usa SELFEMRA fluoxetine hydrochloride TABLET;ORAL 200151-002 Feb 3, 2014 AB1 RX No No   Start Trial   Start Trial   Start Trial
Sandoz OLANZAPINE AND FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride; olanzapine CAPSULE;ORAL 078901-003 Nov 16, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 201336-001 Oct 1, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
Teva FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 075872-001 Jan 29, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Marksans Pharma FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride CAPSULE;ORAL 075465-001 Jan 29, 2002 AB1 RX No No   Start Trial   Start Trial   Start Trial
Teva FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride TABLET;ORAL 075872-002 Jan 4, 2019 AB RX No 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 fluoxetine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly PROZAC WEEKLY fluoxetine hydrochloride CAPSULE, DELAYED REL PELLETS;ORAL 021235-001 Feb 26, 2001   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987   Start Trial   Start Trial
Eli Lilly And Co SARAFEM fluoxetine hydrochloride CAPSULE;ORAL 018936-008 Jul 6, 2000   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-006 Dec 23, 1992   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987   Start Trial   Start Trial
Eli Lilly And Co PROZAC fluoxetine hydrochloride CAPSULE;ORAL 018936-001 Dec 29, 1987   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Medtronic
Boehringer Ingelheim
Mallinckrodt
Moodys

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