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Generated: May 20, 2018

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Moxifloxacin hydrochloride - Generic Drug Details

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What are the generic drug sources for moxifloxacin hydrochloride and what is the scope of moxifloxacin hydrochloride freedom to operate?

Moxifloxacin hydrochloride
is the generic ingredient in six branded drugs marketed by Novartis Pharms Corp, Akorn, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Watson Labs Inc, Bayer Hlthcare, Fresenius Kabi Usa, Mylan Labs Ltd, Crossmedika Sa, Dr Reddys Labs Ltd, Msn Labs Pvt Ltd, Mylan Pharms Inc, Novel Labs Inc, Teva Pharms Usa, and Torrent Pharms Ltd, and is included in twenty NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Moxifloxacin hydrochloride has one hundred and ninety-one patent family members in forty-three countries.

There are eighteen drug master file entries for moxifloxacin hydrochloride. Thirty-two suppliers are listed for this compound. There are two tentative approvals for this compound.
Pharmacology for moxifloxacin hydrochloride
Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial
Synonyms for moxifloxacin hydrochloride
(4aS-cis)-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(octahydro-6H-pyrrolol(3,4-b)pyridin-6-yl)-4-oxo-3-quinolinecarboxylic acid, monohydrochloride
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-((4aS,7aS)-octahydro-6H-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-3-quinolinecarboxylic acid, monohydrochloride
1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid Hydrochloride
1-Cyclopropyl-6-fluoro-7-((4aS,7aS)-hexahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-yl)-8-methoxy-4-oxo-1,4
1-Cyclopropyl-6-fluoro-7-((4aS,7aS)-hexahydro-1H-pyrrolo[3,4-b]pyridin-6(2H)-yl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid HCl
1-cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride
1-cyclopropyl-6-fluoro-8-methoxy-7-((4aS,7aS)-octahydropyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride
1-cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride
1-Cyclopropyl-6-fluoro-8-methoxy-7-[(4aS,7aS)-octahydropyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride
186826-86-8
186826-86-8 151096-09-2(base)
192927-63-2
3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-((4aS,7aS)-octahydro-6H-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-, monohydrochloride
3-Quinolinecarboxylic acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-((4aS,7aS)-octahydro-6H-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-,monohydrochloride
7-[(4aS,7aS)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxo-quinoline-3-carboxylic acid hydrochloride
7-[(4aS,7aS)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic acid hydrochloride
7-[(4aS,7aS)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic acid;hydrochloride
7-[(4aS,7aS)-octahydro-1H-pyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride
826M868
AB0016427
AC-1275
AC1L2R0P
ACT02692
Actira
AK-72941
AKOS015920132
AKOS016015225
AN-15101
API0005432
AT-15459
Avalox
Avelox
Avelox (TN)
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
BAY 12-0839
Bay-12-8039
BAY-128039
BAY12-8039
BC205778
BCP0726000173
BCP9000963
BR-72941
C-22335
C21H24FN3O4.HCl
C21H25ClFN3O4
C53598599T
CAS-186826-86-8
CC-31016
cc-97
CCG-100924
CHEBI:7008
CHEMBL1200735
CM0156
CPD000469185
CS-1063
D00874
DSSTox_CID_25921
DSSTox_GSID_45921
DSSTox_RID_81224
DTXSID4045921
FT-0080006
FT-0082441
HE320859
HY-66011
IDIIJJHBXUESQI-DFIJPDEKSA-N
Izilox
KB-78950
KS-1181
LS-173737
M2479
MFCD00949117
MFLX
MLS001401368
MolPort-005-934-227
Moxifloxacin (Hydrochloride)
Moxifloxacin for peak identification, European Pharmacopoeia (EP) Reference Standard
Moxifloxacin HCl
Moxifloxacin hydrochloride (JAN/USAN)
Moxifloxacin hydrochloride [USAN:USP]
Moxifloxacin hydrochloride [USAN]
Moxifloxacin hydrochloride, >=98% (HPLC)
Moxifloxacin hydrochloride, European Pharmacopoeia (EP) Reference Standard
Moxifloxacin Hydrochloride, pharmaceutical secondary standard; traceable to USP, PhEur
Moxifloxacin hydrochloride, United States Pharmacopeia (USP) Reference Standard
Moxifloxacin hydrochloride, VETRANAL(TM), analytical standard
Moxifloxacine hydrochloride
Moxivig
NC00174
NCGC00095130-01
NCGC00271749-02
O381
Octegra
RL02375
S-3681
S1465
SAM001246654
SCHEMBL37285
SMR000469185
ST2413518
Tox21_111439
Tox21_111439_1
UNII-C53598599T
Vegamox
Vigamox
Vigamox (TN)
Tentative approvals for MOXIFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up0.5%SOLUTION; OPHTHALMIC
➤ Sign Up➤ Sign Up0.5%SOLUTION; OPHTHALMIC

US Patents and Regulatory Information for moxifloxacin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 206242-001 Oct 4, 2017 AT1 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;IV (INFUSION) 021277-001 Nov 30, 2001 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 076938-001 Mar 4, 2014 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 090080-001 Jun 30, 2017 AT1 RX No 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

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Expired US Patents for moxifloxacin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;IV (INFUSION) 021277-001 Nov 30, 2001 ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;IV (INFUSION) 021277-001 Nov 30, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for moxifloxacin hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,509,327 Compositions and methods for treating otic, ophthalmic and nasal infections ➤ Sign Up
6,395,746 Methods of treating ophthalmic, otic and nasal infections and attendant inflammation ➤ Sign Up
8,993,636 Compositions containing moxifloxacin for treating otic infections ➤ Sign Up
6,740,664 Methods for treating otic and ophthalmic infections ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for moxifloxacin hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004012 Lithuania ➤ Sign Up PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-__ 1,4-DIHIDRO-8-METOKSI-7-[(4AS, 7AS)-OKTAHIDRO-6H-PIROLO[3,4-B]PIRIDIN_-6-IL]-4-OKSO-3-CHINOLINKARBOKSIRûGðTIES HIDROCHLORIDAS)
00111 Netherlands ➤ Sign Up PRODUCT NAME: MOXIFLOXACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER MOXIFLOXACINEHYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 28118 RVG 28119 20021017; FIRST REGISTRATION: DE 45263.00.00 19990621
01C/030 Belgium ➤ Sign Up PRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
2004012,C0780390 Lithuania ➤ Sign Up PRODUCT NAME: MOXIFLOXACINI HYDROCHLORIDUM (1-CIKLOPROPIL-6-FLUOR-1,4-DIHIDRO-8-METOKSI-7-((4AS, 7AS)-OKTAHIDRO-6H-PIROLO(3,4-B)PIRIDIN-6-IL)-4-OKSO-3-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Medtronic
Moodys
UBS
Daiichi Sankyo
Healthtrust
Merck
Federal Trade Commission

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