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FLUOXETINE HYDROCHLORIDE Drug Profile
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When do Fluoxetine Hydrochloride patents expire, and what generic alternatives are available?
Fluoxetine Hydrochloride is a drug marketed by Barr, Dr Reddys Labs Ltd, 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, 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, and Upsher Smith Labs. and is included in fifty-eight NDAs.
The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Fluoxetine Hydrochloride
A generic version of FLUOXETINE HYDROCHLORIDE was approved as fluoxetine hydrochloride by APNAR PHARMA LP on January 26th, 2020.
Summary for FLUOXETINE HYDROCHLORIDE
| US Patents: | 0 |
| Applicants: | 41 |
| NDAs: | 58 |
| Suppliers / Packagers: | 60 |
| Bulk Api Vendors: | 123 |
| Clinical Trials: | 238 |
| Patent Applications: | 3,683 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FLUOXETINE HYDROCHLORIDE |
| DailyMed Link: | FLUOXETINE HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for FLUOXETINE HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Huadong Hospital | N/A |
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | N/A |
| Yale University | Phase 1 |
Recent Litigation for FLUOXETINE HYDROCHLORIDE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| 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 Company | 2011-12-07 |
Pharmacology for FLUOXETINE HYDROCHLORIDE
| Drug Class | Serotonin Reuptake Inhibitor |
| Mechanism of Action | Serotonin Uptake Inhibitors |
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-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 (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 |
| 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 FLUOXETINE HYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PROZAC | SOLUTION;ORAL | fluoxetine hydrochloride | 020101 | |
| 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 |
