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Last Updated: November 21, 2024

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

There are seventy-eight drug master file entries for ofloxacin. Thirty-one 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
IVIEW Therapeutics Inc.Phase 2
Jagiellonian UniversityN/A
Centre Hospitalier Universitaire, AmiensN/A

See all ofloxacin clinical trials

Generic filers with tentative approvals for OFLOXACIN
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up400MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up300MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up200MGTABLET;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
Amneal OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 211524-001 Mar 1, 2024 AT RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ranbaxy Labs Ltd OFLOXACIN ofloxacin TABLET;ORAL 076220-001 Sep 2, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys Labs Ltd OFLOXACIN ofloxacin TABLET;ORAL 077098-003 Feb 10, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alvogen OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076830-001 Aug 31, 2004 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva OFLOXACIN ofloxacin TABLET;ORAL 076182-003 Sep 2, 2003 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Ranbaxy Labs Ltd OFLOXACIN ofloxacin TABLET;ORAL 076220-002 Sep 2, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bedford OFLOXACIN ofloxacin INJECTABLE;INJECTION 075762-001 Jan 16, 2002 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ofloxacin INJECTABLE;INJECTION 020087-002 Mar 31, 1992 ⤷  Sign Up ⤷  Sign Up
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-004 Mar 31, 1992 ⤷  Sign Up ⤷  Sign Up
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-005 Mar 31, 1992 ⤷  Sign Up ⤷  Sign Up
Daiichi FLOXIN OTIC ofloxacin SOLUTION/DROPS;OTIC 020799-001 Dec 16, 1997 ⤷  Sign Up ⤷  Sign Up
Allergan OCUFLOX ofloxacin SOLUTION/DROPS;OPHTHALMIC 019921-001 Jul 30, 1993 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-001 Dec 28, 1990 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-003 Dec 28, 1990 ⤷  Sign Up ⤷  Sign Up
>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.