Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

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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 patent protection?

Moxifloxacin hydrochloride is the generic ingredient in six branded drugs marketed by Novartis, Akorn, Alembic Pharms Ltd, 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, Novel Labs Inc, Sunshine Lake, Teva Pharms Usa, and Torrent, and is included in twenty-two 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 is one tentative approval for this compound.

Recent Clinical Trials for moxifloxacin hydrochloride

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

SponsorPhase
Aravind Eye Care SystemPhase 4
Thomas M. LietmanPhase 4
Kaiser PermanentePhase 4

See all moxifloxacin hydrochloride clinical trials

Recent Litigation for moxifloxacin hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Alcon Pharmaceuticals Ltd. v. Imprimis Pharmaceuticals, Inc.2016-06-30
Alcon Pharmaceuticals Ltd. v. Akorn, Inc.2015-10-21
Alcon Pharmaceuticals Ltd v. Lupin Ltd.2012-07-24

See all moxifloxacin hydrochloride litigation

PTAB Litigation
PetitionerDate
Apotex Inc.2012-10-12
Apotex Inc.2012-10-05

See all moxifloxacin hydrochloride litigation

Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.5%SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for moxifloxacin hydrochloride
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-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid hydrochloride (1:1)
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-4-oxo-7-((4aS,7aS)-tetrahydro-1H-pyrrolo[3,4-b]pyridin-6(2H,7H,7aH)-yl)-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
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
BCP03623
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
HY-66011
IDIIJJHBXUESQI-DFIJPDEKSA-N
Izilox
KB-78950
KS-1181
LS-173737
M2479
MFCD00949117
MFLX
MLS001401368
MolPort-005-934-227
Moxeza
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; Certified Reference Material
Moxifloxacin hydrochloride, United States Pharmacopeia (USP) Reference Standard
Moxifloxacin hydrochloride, VETRANAL(TM), analytical standard
Moxifloxacin, HCl
Moxifloxacine hydrochloride
Moxivig
NC00174
NCGC00095130-01
NCGC00271749-02
O381
Octegra
RL02375
S-3681
S1465
SAM001246654
SCHEMBL37285
SMR000469185
ST2413518
SW197554-3
Tox21_111439
Tox21_111439_1
UNII-C53598599T
Vegamox
Vigamox
Vigamox (TN)
Paragraph IV (Patent) Challenges for MOXIFLOXACIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER SOLUTION;INTRAVENOUS moxifloxacin hydrochloride 021277 2014-02-07
MOXEZA SOLUTION/DROPS;OPHTHALMIC moxifloxacin hydrochloride 022428 2012-02-29
VIGAMOX SOLUTION/DROPS;OPHTHALMIC moxifloxacin hydrochloride 021598 2005-12-22
AVELOX TABLET;ORAL moxifloxacin hydrochloride 021085

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
Alembic Pharms Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 209469-001 Feb 13, 2019 AT1 RX No No   Start Trial   Start Trial   Start Trial
Msn Labs Pvt Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 208682-001 Sep 22, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010 AT2 RX Yes Yes   Start Trial   Start Trial 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 moxifloxacin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 021277-001 Nov 30, 2001   Start Trial   Start Trial
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999   Start Trial   Start Trial
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 021277-001 Nov 30, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for moxifloxacin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0780390 PA2004012 Lithuania   Start Trial 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)
0350733 2001C/030 Belgium   Start Trial PRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
0350733 11/2000 Austria   Start Trial PRODUCT NAME: MOXIFLOXACIN, DESSEN PHARMAZEUTISCH VERWENDBARE HYDRATE UND SAEUREADDITIONSSALZE, DESSEN ALKALI-ERDALKALI-SILBER- UND GUANIDINIUMSALZE, SOWIE DESSEN C1 - C4 ALKYL- ODER; NAT. REGISTRATION NO/DATE: 1-23494, 1-23495, 1-23496 20000215; FIRST REGISTRATION: DE 45263.00.00 19990621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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