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Ofloxacin - Generic Drug Details

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

Ofloxacin
is the generic ingredient in six branded drugs marketed by Ortho Mcneil Pharm, Bedford, Allergan, Akorn, Altaire Pharms Inc, Alvogen, Apotex Inc, Bausch And Lomb, Fdc Ltd, Hi Tech Pharma, Sandoz, Sandoz Inc, Daiichi, Janssen Pharms, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-one drug master file entries for ofloxacin. Thirty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for ofloxacin

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Tentative approvals for OFLOXACIN

Applicant Application No. Strength Dosage Form
u► Subscribe200MGTABLET;ORAL
u► Subscribe400MGTABLET;ORAL
u► Subscribe300MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
BedfordOFLOXACINofloxacinINJECTABLE;INJECTION075762-001Jan 16, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen PharmsFLOXINofloxacinTABLET;ORAL019735-001Dec 28, 1990DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Larken LabsOFLOXACINofloxacinTABLET;ORAL076093-003Sep 2, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ortho Mcneil PharmFLOXINofloxacinINJECTABLE;INJECTION020087-003Mar 31, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Cadila Pharms LtdOFLOXACINofloxacinTABLET;ORAL091656-003Sep 18, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Altaire Pharms IncOFLOXACINofloxacinSOLUTION/DROPS;OPHTHALMIC202692-001Apr 29, 2013ATRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Cadila Pharms LtdOFLOXACINofloxacinTABLET;ORAL091656-002Sep 18, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Ortho Mcneil PharmFLOXIN IN DEXTROSE 5%ofloxacinINJECTABLE;INJECTION020087-001Mar 31, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Dr Reddys Labs LtdOFLOXACINofloxacinTABLET;ORAL077098-001Feb 10, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Larken LabsOFLOXACINofloxacinTABLET;ORAL076093-001Sep 2, 2003DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AllerganOCUFLOXofloxacinSOLUTION/DROPS;OPHTHALMIC019921-001Jul 30, 1993► Subscribe► Subscribe
Ortho Mcneil PharmFLOXINofloxacinINJECTABLE;INJECTION020087-002Mar 31, 1992► Subscribe► Subscribe
DaiichiFLOXIN OTICofloxacinSOLUTION/DROPS;OTIC020799-001Dec 16, 1997► Subscribe► Subscribe
Janssen PharmsFLOXINofloxacinTABLET;ORAL019735-001Dec 28, 1990► Subscribe► Subscribe
AllerganOCUFLOXofloxacinSOLUTION/DROPS;OPHTHALMIC019921-001Jul 30, 1993► Subscribe► Subscribe
Ortho Mcneil PharmFLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINERofloxacinINJECTABLE;INJECTION020087-004Mar 31, 1992► Subscribe► Subscribe
Janssen PharmsFLOXINofloxacinTABLET;ORAL019735-002Dec 28, 1990► Subscribe► Subscribe
Ortho Mcneil PharmFLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINERofloxacinINJECTABLE;INJECTION020087-005Mar 31, 1992► Subscribe► Subscribe
Janssen PharmsFLOXINofloxacinTABLET;ORAL019735-003Dec 28, 1990► Subscribe► Subscribe
Ortho Mcneil PharmFLOXIN IN DEXTROSE 5%ofloxacinINJECTABLE;INJECTION020087-001Mar 31, 1992► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Chubb
McKesson
Cipla
Mallinckrodt
Cerilliant
AstraZeneca
Healthtrust
Moodys
Daiichi Sankyo
McKinsey

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