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Last Updated: March 28, 2024

Ofloxacin - Generic Drug Details


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What are the generic drug sources for ofloxacin and what is the scope of patent protection?

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
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-003 Dec 28, 1990 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mankind Pharma OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 216130-001 Jul 14, 2022 AT RX 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
Amneal OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 211525-001 Aug 30, 2019 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Caplin OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 217903-001 Jan 5, 2024 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
Ortho Mcneil Pharm FLOXIN ofloxacin INJECTABLE;INJECTION 020087-002 Mar 31, 1992 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-002 Dec 28, 1990 ⤷  Try a Trial ⤷  Try a Trial
Allergan OCUFLOX ofloxacin SOLUTION/DROPS;OPHTHALMIC 019921-001 Jul 30, 1993 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-001 Dec 28, 1990 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-003 Dec 28, 1990 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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