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Generated: June 26, 2019

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MOXIFLOXACIN HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for moxifloxacin hydrochloride and what is the scope of moxifloxacin hydrochloride patent protection?

Moxifloxacin hydrochloride is the generic ingredient in six branded drugs marketed by Novartis Pharms Corp, 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-six suppliers are listed for this compound. There are two tentative approvals for this compound.

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)
Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial0.5%SOLUTION; OPHTHALMIC
➤ Try a Free Trial➤ Try a Free 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.

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
Novel Labs Inc MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 207285-001 Feb 13, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Msn Labs Pvt Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 208682-001 Sep 22, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Watson Labs Inc MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 202525-001 Mar 6, 2015 AT1 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010 AT2 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis Pharms Corp MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010 AT2 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Lupin Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 204079-001 May 28, 2015 AT2 RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
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

Supplementary Protection Certificates for MOXIFLOXACIN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0350733 11/2000 Austria ➤ Try a Free 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
0350733 SPC/GB03/034 United Kingdom ➤ Try a Free Trial PRODUCT NAME: MOXIFLOXACIN AND PHARMACEUTICALLY USABLE HYDRATES AND ACID ADDITION SALTS THEREOF AND THE ALKALI METAL, ALKALINE EARTH METAL, SILVER AND GUANIDINIUM SALTS OF THE UNDERLYING CARBOXYLIC ACIDS AND THE RACEMATES THEREOF; REGISTERED: DE 45263.00.00 19990621; UK PL 000 10/0291 20030313
0780390 PA2004012 Lithuania ➤ Try a Free 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 C300111 Netherlands ➤ Try a Free Trial 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
0350733 2001C/030 Belgium ➤ Try a Free 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
0780390 PA2004012,C0780390 Lithuania ➤ Try a Free 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-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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