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LEVOFLOXACIN Drug Profile
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Levofloxacin is a drug marketed by Akorn, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Emcure Pharms Ltd, Hospira Inc, Mylan Asi, Zydus Pharms, Apotex Inc, Micro Labs Ltd India, Mylan Labs Ltd, Rising, Watson Labs Teva, Hi Tech Pharma, Lannett Co Inc, Celltrion, Cipla Ltd, Dr Reddys Labs Inc, Glenmark Generics, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Mylan, Orchid Hlthcare, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Zydus Pharms Usa Inc, Fresenius Kabi Usa, Hikma Farmaceutica, and Inforlife. and is included in forty NDAs.
The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty-one drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
US ANDA Litigation and Generic Entry Outlook for Levofloxacin
A generic version of LEVOFLOXACIN was approved as levofloxacin by AKORN on December 20th, 2010.
Summary for LEVOFLOXACIN
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Recent Clinical Trials for LEVOFLOXACIN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Slovenian Society for Gastroenterology and Hepatology | N/A |
| KRKA | N/A |
| Otsuka Pharmaceutical Co., Ltd. | Phase 3 |
Recent Litigation for LEVOFLOXACIN
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Senju Pharmaceutical Co. v. Lupin Limited | 2013-09-10 |
| Senju Pharmaceutical Co. Ltd. v. Apotex Inc. | 2012-02-10 |
| Senju Pharmaceutical Co. Ltd. v. Lupin Limited | 2011-03-31 |
Medical Subject Heading (MeSH) Categories for LEVOFLOXACIN
Synonyms for LEVOFLOXACIN
| (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid |
| (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyridol[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate |
| (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7Hpyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate |
| (-)-Ofloxacin |
| (-)-Ofloxacin; (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazin-yl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid |
| ()-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1;()-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1 |
| (2S)-7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.0^{5,13}]trideca-5(13),6,8,11-tetraene-11-carboxylic acid |
| (3S)-(-)-9-Fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid |
| (3s)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7h-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid |
| (3S)-9-Fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid |
| (3S)-9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid |
| (R)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid |
| (R)-isomer |
| (S)-(-)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzooxazine-6-carboxylic acid |
| (S)-(-)-Ofloxacin |
| (S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid |
| (S)-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]-benzoxazine-6-carboxylic acid |
| (S)-9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid |
| (S)-Ofloxacin |
| 100986-85-4 |
| 7H-Pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid, 2,3-dihydro-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, (S)- |
| 7H-Pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid, 2,3-dihydro-9-fluoro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, hemihydrate, (S)- |
| 7H-Pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid, 9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, (3S)- |
| 986L854 |
| AB00171657_14 |
| AB00171657_15 |
| AB00171657-12 |
| AB00171657-13 |
| AB0072147 |
| AB1009501 |
| AC-7593 |
| Aeroquin |
| AK163316 |
| AKOS008901361 |
| AKOS015895104 |
| Anhydrous Ofloxacin |
| API0007780 |
| AS-31796 |
| BDBM50366826 |
| BG0235 |
| BIL1009 |
| BRD-K09471561-001-06-7 |
| BSPBio_002689 |
| C07660 |
| C18H20FN3O4 |
| C18H20FN3O4.H2O |
| CCG-39093 |
| CCRIS 4073 |
| CCRIS 4074 |
| CHEBI:63598 |
| CPD000466387 |
| Cravit |
| Cravit (TN) |
| Cravit hydrate |
| Cravit IV |
| CS-2218 |
| D08120 |
| DB01137 |
| DE-108 |
| DR-3355 |
| DR-3355: L-isomer of ofloxacin |
| DR3355 |
| DTXSID0041060 |
| EBD8264 |
| Elequine |
| EX-A1488 |
| Floxacin |
| fluoro-methyl-(4-methylpiperazin-1-yl)-oxo-[?]carboxylic acid |
| FT-0627808 |
| GSDSWSVVBLHKDQ-JTQLQIEISA-N |
| HMS1922J07 |
| HMS2051G04 |
| HMS2090O10 |
| HMS2093E18 |
| HMS2232G06 |
| HR 355 |
| HR-355 |
| HSDB 8028 |
| HY-B0330 |
| Iquix |
| Iquix hydrate |
| KBio2_002199 |
| KBio2_004767 |
| KBio2_007335 |
| KBio3_001909 |
| KBioGR_001605 |
| KBioSS_002199 |
| L-Ofloxacin |
| L0193 |
| Levaquin |
| Levaquin (TN) |
| Levaquin hydrate |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
| Levo Floxacin |
| Levofiexacin |
| Levofloxacin (INN) |
| Levofloxacin (Levaquin) |
| Levofloxacin [USAN:INN:JAN] |
| Levofloxacin Anhydrous |
| Levofloxacin hydrate |
| Levofloxacin solution, 1.0 mg/mL in acetonitrile, certified reference material |
| Levofloxacin tablet, suspension or intravenous |
| levofloxacin-levaquin |
| Levofloxacin, >=98.0% (HPLC) |
| Levofloxacin, analytical reference material |
| Levofloxacin, Antibiotic for Culture Media Use Only |
| Levofloxacin,(S) |
| Levofloxacine |
| Levofloxacine [INN-French] |
| Levofloxacino |
| Levofloxacino [INN-Spanish] |
| Levofloxacinum |
| Levofloxacinum [INN-Latin] |
| LFX |
| Loxof |
| LS-133260 |
| LS-171761 |
| LVFX; RWJ 25213; L-Ofloxacin; Ophthalmic; (-)-(S)-9-Fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazin-yl)-7-oxo-7H-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic acid |
| LVX |
| MCULE-2011834955 |
| MLS000759524 |
| MLS001165709 |
| MLS001423977 |
| MMV687798 |
| MP 376 |
| MP-376 |
| NC00094 |
| NCGC00178529-01 |
| NCGC00178529-03 |
| NSC-758709 |
| NSC758709 |
| Ofloxacin S-(-)-form |
| Ofloxacin s-(-)-form hemihydrate |
| Ofloxcacin |
| Oftaquix |
| Pharmakon1600-01504260 |
| Q-201295 |
| Q424193 |
| Quixin |
| RIX4E89Y14 |
| RWJ 25213-097 |
| RWJ-25213 |
| S-(-)-Ofloxacin |
| S-ofloxacin |
| s1940 |
| SAM001246758 |
| SBI-0206768.P001 |
| SCHEMBL15397 |
| SMR000466387 |
| SPBio_001891 |
| Spectrum_001719 |
| SPECTRUM1504260 |
| Spectrum2_001676 |
| Spectrum3_000995 |
| Spectrum4_001123 |
| Spectrum5_001438 |
| SR-05000001999 |
| SR-05000001999-1 |
| ST24047487 |
| Tavanic |
| Unibiotic |
| UNII-A4P49JAZ9H component GSDSWSVVBLHKDQ-JTQLQIEISA-N |
| UNII-RIX4E89Y14 |
| Venaxan |
| Z1766089137 |
| ZINC538273 |
| ZX-AFC000651 |
Paragraph IV (Patent) Challenges for LEVOFLOXACIN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LEVAQUIN | SOLUTION;ORAL | levofloxacin | 021721 | 2009-07-30 |
| LEVAQUIN | INJECTABLE;INJECTION | levofloxacin | 020635 | |
| LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | INJECTABLE;INJECTION | levofloxacin | 020635 | |
| QUIXIN | SOLUTION/DROPS;OPHTHALMIC | levofloxacin | 021199 | |
| LEVAQUIN | TABLET;ORAL | levofloxacin | 020634 |
US Patents and Regulatory Information for LEVOFLOXACIN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms Usa Inc | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 077652-001 | Sep 7, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hec Pharm | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 204968-002 | Feb 5, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Cipla Ltd | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 076890-002 | Mar 30, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hikma Farmaceutica | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 091375-003 | Sep 16, 2011 | AP | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Lupin | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 078424-002 | Jun 20, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sandoz | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 077438-001 | Jun 20, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Hetero Labs Ltd V | LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 202801-003 | Jan 8, 2015 | 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 |
