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Last Updated: March 19, 2024

OFLOXACIN - Generic Drug Details


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What are the generic drug 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, Altaire Pharms Inc, Alvogen, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Fdc Ltd, Mankind Pharma, Sandoz, Sentiss, Daiichi, Amneal, Caplin, Hikma, Janssen Pharms, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seventy-eight drug master file entries for ofloxacin. Twenty-six 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

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SponsorPhase
IVIEW Therapeutics Inc.Phase 2
Centre Hospitalier Universitaire, AmiensN/A
University of PatrasPhase 4

See all OFLOXACIN clinical trials

Generic filers with tentative approvals for OFLOXACIN
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial400MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial300MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial200MGTABLET;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
Ranbaxy Labs Ltd OFLOXACIN ofloxacin TABLET;ORAL 076220-001 Sep 2, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-001 Dec 28, 1990 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076513-001 May 14, 2004 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alvogen OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076830-001 Aug 31, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 076527-001 Sep 28, 2007 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Altaire Pharms Inc OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 202692-001 Apr 29, 2013 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bausch And Lomb OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076622-001 May 14, 2004 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Daiichi FLOXIN OTIC ofloxacin SOLUTION/DROPS;OTIC 020799-001 Dec 16, 1997 ⤷  Try a Trial ⤷  Try a Trial
Ortho Mcneil Pharm FLOXIN ofloxacin INJECTABLE;INJECTION 020087-002 Mar 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-005 Mar 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
Allergan OCUFLOX ofloxacin SOLUTION/DROPS;OPHTHALMIC 019921-001 Jul 30, 1993 ⤷  Try a Trial ⤷  Try a Trial
Allergan OCUFLOX ofloxacin SOLUTION/DROPS;OPHTHALMIC 019921-001 Jul 30, 1993 ⤷  Try a Trial ⤷  Try a Trial
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-004 Mar 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
Ortho Mcneil Pharm FLOXIN ofloxacin INJECTABLE;INJECTION 020087-003 Mar 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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 verification 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.