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:	92
Clinical Trials:	2
Patent Applications:	2,430
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

Sponsor	Phase
Samsung Medical Center	Phase 3
LG Life Sciences	Phase 1

See all FACTIVE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for FACTIVE

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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 FACTIVE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	⤷ Try a Trial	⤷ Try a Trial
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	⤷ Try a Trial	⤷ Try a Trial
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	⤷ Try a Trial	⤷ Try a Trial
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FACTIVE

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

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Country	Patent Number	Title	Estimated Expiration
Brazil	9808290		⤷ Try a Trial
Portugal	1179533		⤷ Try a Trial
Eurasian Patent Organization	199900855		⤷ Try a Trial
Slovenia	0981527		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for FACTIVE

Recent Clinical Trials for FACTIVE

Anatomical Therapeutic Chemical (ATC) Classes for FACTIVE

Paragraph IV (Patent) Challenges for FACTIVE

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