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Last Updated: June 28, 2022

Ofloxacin - Generic Drug Details


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What are the generic sources for ofloxacin and what is the scope of 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, Sandoz, Sandoz Inc, Daiichi, Amneal, Janssen Pharms, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-eight drug master file entries for ofloxacin. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for ofloxacin

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Drug Sales Revenue Trends for ofloxacin

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Recent Clinical Trials for ofloxacin

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

SponsorPhase
Centre Hospitalier Universitaire, AmiensN/A
University Hospital of PatrasPhase 4
University of PatrasPhase 4

See all ofloxacin clinical trials

Generic filers with tentative approvals for OFLOXACIN
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing400MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing300MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing200MGTABLET;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 ofloxacin

US Patents and Regulatory Information for ofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Larken Labs OFLOXACIN ofloxacin TABLET;ORAL 076093-002 Sep 2, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Fdc Ltd OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 215038-001 Jan 19, 2022 AT RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-001 Dec 28, 1990 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ranbaxy Labs Ltd OFLOXACIN ofloxacin TABLET;ORAL 076220-003 Sep 2, 2003 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alvogen OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 090395-001 Aug 11, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 ofloxacin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-004 Mar 31, 1992 See Plans and Pricing See Plans and Pricing
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-003 Dec 28, 1990 See Plans and Pricing See Plans and Pricing
Allergan OCUFLOX ofloxacin SOLUTION/DROPS;OPHTHALMIC 019921-001 Jul 30, 1993 See Plans and Pricing See Plans and Pricing
Ortho Mcneil Pharm FLOXIN ofloxacin INJECTABLE;INJECTION 020087-002 Mar 31, 1992 See Plans and Pricing See Plans and Pricing
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% ofloxacin INJECTABLE;INJECTION 020087-001 Mar 31, 1992 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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