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.

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Summary for FACTIVE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	2
Patent Applications:	207
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

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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	⤷ Sign Up	⤷ Sign Up
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	⤷ Sign Up	⤷ Sign Up
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	⤷ Sign Up	⤷ Sign Up
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	⤷ Sign Up	⤷ Sign Up
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	⤷ Sign Up	⤷ Sign Up
Lg Chem Ltd	FACTIVE	gemifloxacin mesylate	TABLET;ORAL	021158-001	Apr 4, 2003	⤷ Sign Up	⤷ Sign Up
>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
Norway	994595		⤷ Sign Up
Norway	312515		⤷ Sign Up
Bulgaria	103750		⤷ Sign Up
Turkey	9902313		⤷ Sign Up
Spain	2213669		⤷ Sign Up
Japan	2004002413	SALT OF NAPHTHYRIDINE CARBOXYLIC ACID DERIVATIVE	⤷ Sign Up
South Korea	100222082		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for FACTIVE

Recent Clinical Trials for FACTIVE

Paragraph IV (Patent) Challenges for FACTIVE

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