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Levofloxacin - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for levofloxacin?

Levofloxacin is the generic ingredient in six branded drugs marketed by Rising Pharms Inc, Orchid Hlthcare, Hetero Labs Ltd V, Dr Reddys Labs Inc, Jubilant Generics, Aurobindo Pharma Ltd, Janssen Pharms, Torrent Pharms, Lupin, Watson Labs Teva, Claris, Sandoz, Macleods Pharms Ltd, Acs Dobfar Info Sa, Akorn, Glenmark Generics, Zydus Pharms Usa Inc, Sagent Pharms, Teva, Wockhardt, Santen, Fresenius Kabi Usa, Hikma Farmaceutica, Mylan, Hospira Inc, Hi Tech Pharma, Apotex Inc, Watson Labs Inc, Emcure Pharms Ltd, and Cipla Ltd, and is included in forty NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for levofloxacin. Sixty-two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: levofloxacin

Tradenames:6
Patents:2
Applicants:30
NDAs:40
Drug Master File Entries: see list28
Suppliers / Packagers: see list62
Bulk Api Vendors: see list48
Clinical Trials: see list56
Patent Applications: see list5,795
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:levofloxacin at DailyMed

Pharmacology for Ingredient: levofloxacin

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Tentative approvals for LEVOFLOXACIN

Applicant Application No. Form Dosage
► Subscribe► SubscribeINJECTABLE; INJECTION5MG/ML
► Subscribe► SubscribeTABLET; ORAL250MG
► Subscribe► SubscribeTABLET; ORAL500MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira Inc
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION078579-002Sep 3, 2015RXNoNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
LEVOFLOXACIN
levofloxacin
INJECTABLE;INJECTION202328-001Jan 24, 2013RXNoNo► Subscribe► Subscribe
Santen
IQUIX
levofloxacin
SOLUTION/DROPS;OPHTHALMIC021571-001Mar 1, 2004DISCNYesNo► Subscribe► Subscribe
Aurobindo Pharma Ltd
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION206919-001Feb 10, 2016RXNoNo► Subscribe► Subscribe
Cipla Ltd
LEVOFLOXACIN
levofloxacin
TABLET;ORAL076890-001Mar 30, 2012RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: levofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santen
QUIXIN
levofloxacin
SOLUTION/DROPS;OPHTHALMIC021199-001Aug 18, 20004,382,892► Subscribe
Janssen Pharms
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION020635-003Dec 20, 19964,382,892► Subscribe
Janssen Pharms
LEVAQUIN
levofloxacin
SOLUTION;ORAL021721-001Oct 21, 20045,053,407*PED► Subscribe
Janssen Pharms
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION020635-002Dec 20, 19964,382,892► Subscribe
Janssen Pharms
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
levofloxacin
INJECTABLE;INJECTION020635-003Dec 20, 19965,053,407*PED► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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