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MOXEZA Drug Profile

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Which patents cover Moxeza, and when can generic versions of Moxeza launch?

Moxeza is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-four patent family members in twenty-two countries.

The generic ingredient in MOXEZA is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

Summary for MOXEZA

International Patents:	94
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	78
Patent Applications:	4,088
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOXEZA
DailyMed Link:	MOXEZA at DailyMed

Pharmacology for MOXEZA

Ingredient-type	Quinolones
Drug Class	Quinolone Antimicrobial

Synonyms for MOXEZA

(1'S,6'S)-1-Cyclopropyl-7-(2,8-diazabicyclo[4.3.0]non-8-yl)-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

1-cyclopropyl-6-fluoro-1,4-dihydro-7-((4aR,7aS)-octahydropyrrolo[3,4-b]pyridin

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

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

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

151096-09-2

192927-63-2

195154-07-5

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-

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-

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-

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

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

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

96M092

AB0011262

AB00171653_15

AB00171653-11

AB00171653-13

AB00171653-14

AC-25913

AC1L49EP

Actira (*Hydrochloride*)

AJ-45743

AK-75805

AKOS015895251

AM84644

AMX10191

AN-1289

ANW-57564

API0004683

Avalox (TN)

Avelon (TN)

Avelox (*Hydrochloride*)

Avelox (TN)

Avelox I.V.

Avelox IV (TN)

Avolex

AX8043888

BAY 12-8039

BAY 12-8039 (*Hydrochloride*)

BCP0726000137

BCP9000962

BDBM50366824

CCG-221192

CCRIS 8690

CHEBI:63611

CS-1895

CTK8B7522

D08237

D0ZV0Z

DB00218

DTXSID3048491

EX-A016

FABPRXSRWADJSP-MEDUHNTESA-N

HE066848

HE211919

HE313568

HSDB 8026

HY-66011A

I06-1961

Izilox

KB-33277

LS-141510

MFCD04117996

MFX

moxifloxacin

Moxifloxacin (INN)

Moxifloxacin [INN:BAN]

Moxifloxacine

moxyfloxacin

MXF

MXFX

Q-9195

SBI-0206792.P001

SCHEMBL24007

ST2403416

TR-035776

U188XYD42P

UNII-U188XYD42P

Vigamox

Vigamox (TN)

ZINC3826253

US Patents and Regulatory Information for MOXEZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharms Corp	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	AT2	RX	Yes	Yes			Y
Novartis Pharms Corp	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	AT2	RX	Yes	Yes					Y
Novartis Pharms Corp	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	AT2	RX	Yes	Yes			Y
Novartis Pharms Corp	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	AT2	RX	Yes	Yes					Y

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Expired US Patents for MOXEZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis Pharms Corp	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010
Novartis Pharms Corp	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010

Paragraph IV (Patent) Challenges for MOXEZA

Drugname	Dosage	Strength	RLD	Submissiondate
	Ophthalmic Solution	10.5%		2012-02-29

Non-Orange Book US Patents for MOXEZA

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
6,395,746	Methods of treating ophthalmic, otic and nasal infections and attendant inflammation
8,993,636	Compositions containing moxifloxacin for treating otic infections
8,673,902	Method of treating otic infections with moxifloxacin compositions

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International Patents for MOXEZA

Country	Document Number	Estimated Expiration
China	1184968
Portugal	2269602
Denmark	1384478
China	104814961

Supplementary Protection Certificates for MOXEZA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
/2000	Austria		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
01C/030	Belgium		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		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
C/GB03/034	United Kingdom		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