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Last Updated: June 24, 2021

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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-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

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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
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
  Try Before You Buy  Try Before You Buy400MGTABLET;ORAL
  Try Before You Buy  Try Before You Buy300MGTABLET;ORAL
  Try Before You Buy  Try Before You Buy200MGTABLET;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
Allergan OCUFLOX ofloxacin SOLUTION/DROPS;OPHTHALMIC 019921-001 Jul 30, 1993 AT RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Alvogen OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076830-001 Aug 31, 2004 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Cadila Pharms Ltd OFLOXACIN ofloxacin TABLET;ORAL 091656-002 Sep 18, 2014 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Alvogen OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 090395-001 Aug 11, 2009 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Sandoz Inc OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076231-001 May 14, 2004 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Bausch And Lomb OFLOXACIN ofloxacin SOLUTION/DROPS;OPHTHALMIC 076622-001 May 14, 2004 AT RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Bausch And Lomb OFLOXACIN ofloxacin SOLUTION/DROPS;OTIC 076128-001 Mar 17, 2008 AT RX No Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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

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