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Serving leading biopharmaceutical companies globally:

Merck
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Harvard Business School

Last Updated: November 13, 2019

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FACTIVE Drug Profile

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When do Factive patents expire, and what generic alternatives are available?

Factive is a drug marketed by Lg Chem Ltd and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has fifteen patent family members in twelve countries.

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
International Patents:15
US Patents:5
Applicants:1
NDAs:1
Bulk Api Vendors: 53
Clinical Trials: 2
Patent Applications: 1,677
Formulation / Manufacturing:see details
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

Synonyms for FACTIVE
(+-)-7-(3-(Aminomethyl)-4-oxo-1-pyrrolidinyl)-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid, 7(sup 4)-(Z)-(O-methyloxime), monomethanesulfonate
(S,Z)-7-(3-(aminomethyl)-4-(methoxyimino)pyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid
(Z)-7-(3-(Aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl)-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid monomethanesulfonate
(Z)-7-(3-(aminomethyl)-4-(methoxyimino)pyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid
1,4-Dihydro-1-cyclopropyl-4-oxo-6-fluoro-7-[3-(aminomethyl)-4-(methoxyimino)pyrrolidine-1-yl]-1,8-naphthyridine-3-carboxylic acid
1,4-Dihydro-6-fluoro-1-cyclopropyl-4-oxo-7-[(3E)-4-(aminomethyl)-3-(methoxyimino)pyrrolidine-1-yl]-1,8-naphthyridine-3-carboxylic acid
1,8-Naphthyridine-3-carboxylic acid, 7-((4Z)-3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl)-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-, monomethanesulfonate
1,8-Naphthyridine-3-carboxylic acid, 7-(3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl)-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-
1,8-Naphthyridine-3-carboxylic acid, 7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-
1,8-Naphthyridine-3-carboxylic acid, 7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-, monomethanesulfonate
175463-14-6
204519-64-2
204519-65-3
210353-52-9
210353-53-0
214346-11-9
214346-13-1
463G146
7-((4Z)-3-(Aminomethyl)-4-methoxyiminopyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-(1,8)naphthyridine-3-carboxylic acid monomethanesulfonate
7-(3-(aminomethyl)-4-(methoxyimino)pyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid
7-(3-Aminomethyl-4-methoxyimino-pyrrolidine-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-(1,8)-naphthyridine-3-carboxylic acid
7-(3-Aminomethyl)-4-methoxyimino-pyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-[1,8]naphthyridine-3-carboxylic acid
7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)pyrrolidin-1-yl]-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid
7-[(4Z)-3-(aminomethyl)-4-methoxyimino-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-4-oxo-1,8-naphthyridine-3-carboxylic acid
7-[(4Z)-3-(aminomethyl)-4-methoxyimino-pyrrolidin-1-yl]-1-cyclopropyl-6-fluoranyl-4-oxidanylidene-1,8-naphthyridine-3-carboxylic acid
7-[(4Z)-3-(aminomethyl)-4-methoxyimino-pyrrolidin-1-yl]-1-cyclopropyl-6-fluoro-4-oxo-1,8-naphthyridine-3-carboxylic acid
7-[3-(Aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic Acid Mesilate
7-[3-(aminomethyl)-4-(methoxyimino)pyrrolidin-1-yl]-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid
7-[3-(aminomethyl)-4-(methoxyimino)pyrrolidin-1-yl]-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-1,8-naphthyridine-3-carboxylic acid methanesulfonate
7-{3-Aminomethyl-4-[(Z)-methoxyimino]-pyrrolidin-1-yl}-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydro-[1,8]naphthyridine-3-carboxylic acid
A812090
AB01563334_01
AKOS015907681
AKOS016010166
AM84619
AN-5497
ARB-FV0127
AS-13809
AX8131932
BDBM50178917
BRD-A40787240-066-02-0
BRD-A40787240-066-03-8
BSPBio_002308
C18H20FN5O4.CH4O3O
CAS-204519-65-3
CCG-39296
CHEBI:101853
CHEBI:53749
CHEMBL1200621
CHEMBL430
CS-4572
D02471
D08012
DB01155
DSSTox_CID_25948
DSSTox_GSID_45948
DSSTox_RID_81245
DTXSID3048495
DTXSID7045948
Factiv (TN)
Factive (TN)
Floxguard
Gemifioxacin
Gemifioxacin Mesylate
Gemifloxacin
Gemifloxacin (INN)
Gemifloxacin (mesylate)
Gemifloxacin [INN]
Gemifloxacin mesilate
Gemifloxacin mesylate
Gemifloxacin mesylate (USAN)
Gemifloxacin mesylate [USAN]
Gemifloxacin mesylate, >=98% (HPLC)
Gemifloxacin; 7-(3-Aminomethyl)-4-methoxyimino-pyrrolidin-1-yl)-1-cyclopropyl-6-fluoro-4-oxo-1, 4-dihydro-[1, 8]naphthyridine-3-carboxylic acid; 210353-56-3
Gemifloxacine
Gemifloxacino
Gemifloxacinum
Gemixa
HMS1922H08
HMS2093D22
HSDB 8027
HY-B1050
J10357
KB-212128
KB-278137
KB-293971
LB 20304
LB 20304a
LB-20304
LB-20304 Mesilate
LB-20304a
LS-186652
LS-186992
LS-187779
M63G146
MolPort-003-666-746
NCGC00095182-01
NCGC00095182-02
NCGC00178711-01
NCGC00178711-03
NSC-759252
NSC759252
Pharmakon1600-01505802
SB 265805
SB 265805S
SB-265805
SB-265805 Mesilate
SB-265805-S
SBI-0206906.P001
SCHEMBL13414391
SCHEMBL136633
SCHEMBL136827
SPECTRUM1505802
SR-05000001958
SR-05000001958-1
SR-05000001958-2
ST24047327
Tox21_111473
Tox21_111473_1
Paragraph IV (Patent) Challenges for FACTIVE
Tradename Dosage Ingredient NDA Submissiondate
FACTIVE TABLET;ORAL gemifloxacin mesylate 021158 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 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Lg Chem Ltd FACTIVE gemifloxacin mesylate TABLET;ORAL 021158-001 Apr 4, 2003 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start 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

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

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Serving leading biopharmaceutical companies globally:

Dow
Merck
Moodys
Boehringer Ingelheim
Mallinckrodt
McKesson

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