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Last Updated: May 28, 2022

FACTIVE Drug Patent Profile


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

Factive is a drug marketed by Lg Chem Ltd and is included in one NDA.

The generic ingredient in FACTIVE is gemifloxacin mesylate. There are two drug master file entries for this compound. Additional details are available on the gemifloxacin mesylate profile page.

Summary for FACTIVE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 45
Clinical Trials: 2
Patent Applications: 181
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in FACTIVE?FACTIVE excipients list
DailyMed Link:FACTIVE at DailyMed
Drug patent expirations by year for FACTIVE
Recent Clinical Trials for FACTIVE

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

SponsorPhase
Samsung Medical CenterPhase 3
LG Life SciencesPhase 1

See all FACTIVE clinical trials

Paragraph IV (Patent) Challenges for FACTIVE
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 FACTIVE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 FACTIVE

International Patents for FACTIVE

See the table below for patents covering FACTIVE around the world.

Country Patent Number Title Estimated Expiration
Slovenia 0981527 See Plans and Pricing
African Intellectual Property Organization (OAPI) 11161 Salt of naphthyridine carboxylic acid derivative See Plans and Pricing
Iceland 5181 See Plans and Pricing
Japan H0841050 NOVEL QUINOLINECARBOXYLIC ACID DERIVATIVE HAVING 7-(4-AMINOMETHYL-3-OXIME)PYRROLIDINE SUBSTITUTION AND ITS PRODUCTION See Plans and Pricing
Russian Federation 2120940 ПРОИЗВОДНЫЕ ХИНОЛИН- ИЛИ НАФТИРИДИНКАРБОНОВОЙ КИСЛОТЫ И СПОСОБЫ ИХ ПОЛУЧЕНИЯ (DERIVATIVES OF QUINOLINE- OR NAPHTHYRIDINE CARBOXYLIC ACID AND METHODS OF THEIR SYNTHESIS) See Plans and Pricing
Austria 383157 See Plans and Pricing
Czech Republic 9903282 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Boehringer Ingelheim
McKesson
Colorcon
Johnson and Johnson

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.