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Last Updated: June 22, 2021

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OFLOXACIN Drug Profile


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Which patents cover Ofloxacin, and what generic alternatives are available?

Ofloxacin is a drug marketed by Bedford, Akorn, Altaire Pharms Inc, Alvogen, Apotex Inc, Bausch And Lomb, Fdc Ltd, Sandoz, Sandoz Inc, Amneal, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Larken Labs, Ranbaxy Labs Ltd, and Teva. and is included in twenty-one NDAs.

The generic ingredient in OFLOXACIN is ofloxacin. There are seventy-eight drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ofloxacin

A generic version of OFLOXACIN was approved as ofloxacin by TEVA on September 2nd, 2003.

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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
Ranbaxy Labs Ltd OFLOXACIN ofloxacin TABLET;ORAL 076220-003 Sep 2, 2003 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Teva OFLOXACIN ofloxacin TABLET;ORAL 076182-001 Sep 2, 2003 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Bedford OFLOXACIN ofloxacin INJECTABLE;INJECTION 075762-001 Jan 16, 2002 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
Larken Labs OFLOXACIN ofloxacin TABLET;ORAL 076093-002 Sep 2, 2003 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
Baxter
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Express Scripts
Colorcon

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