➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
McKinsey
Merck
Harvard Business School
Baxter

Last Updated: July 28, 2021

DrugPatentWatch Database Preview

OFLOXACIN - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

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, 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-five NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for OFLOXACIN

See drug prices for OFLOXACIN

Drug Sales Revenue Trends for OFLOXACIN

See drug sales revenues for OFLOXACIN

Recent Clinical Trials for OFLOXACIN

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

SponsorPhase
Centre Hospitalier Universitaire, AmiensN/A
Montefiore Medical CenterPhase 3
Cancer Research NetworkPhase 2

See all OFLOXACIN clinical trials

Generic filers with tentative approvals for OFLOXACIN
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial400MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial300MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever 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
Paragraph IV (Patent) Challenges for OFLOXACIN
Tradename Dosage Ingredient NDA Submissiondate
FLOXIN OTIC SOLUTION/DROPS;OTIC ofloxacin 020799

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
Fdc Ltd OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 078559-001 Feb 25, 2009 AT RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Sandoz OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076848-001 Nov 25, 2008 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-001 Dec 28, 1990 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER ofloxacin INJECTABLE;INJECTION 020087-004 Mar 31, 1992 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Alvogen OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076830-001 Aug 31, 2004 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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
Allergan OCUFLOX ofloxacin SOLUTION/DROPS;OPHTHALMIC 019921-001 Jul 30, 1993 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-003 Dec 28, 1990 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ortho Mcneil Pharm FLOXIN ofloxacin INJECTABLE;INJECTION 020087-002 Mar 31, 1992 ⤷  Free Forever Trial ⤷  Free Forever Trial
Ortho Mcneil Pharm FLOXIN IN DEXTROSE 5% ofloxacin INJECTABLE;INJECTION 020087-001 Mar 31, 1992 ⤷  Free Forever Trial ⤷  Free Forever Trial
Janssen Pharms FLOXIN ofloxacin TABLET;ORAL 019735-001 Dec 28, 1990 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
McKinsey
Merck
Harvard Business School
Baxter

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.