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Last Updated: December 1, 2022

Gemifloxacin mesylate - Generic Drug Details


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

Gemifloxacin mesylate is the generic ingredient in two branded drugs marketed by Lg Chem Ltd and Orbion Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for gemifloxacin mesylate.

Summary for gemifloxacin mesylate
US Patents:0
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 50
Patent Applications: 311
What excipients (inactive ingredients) are in gemifloxacin mesylate?gemifloxacin mesylate excipients list
DailyMed Link:gemifloxacin mesylate at DailyMed
Paragraph IV (Patent) Challenges for GEMIFLOXACIN MESYLATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FACTIVE Tablets gemifloxacin mesylate 320 mg 021158 1 2008-03-04

US Patents and Regulatory Information for gemifloxacin mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orbion Pharms GEMIFLOXACIN MESYLATE gemifloxacin mesylate TABLET;ORAL 090466-001 Jun 15, 2015 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 gemifloxacin mesylate

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Medtronic
Baxter
McKesson
Moodys
Colorcon

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