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AVELOX Drug Profile

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When do Avelox patents expire, and when can generic versions of Avelox launch?

Avelox is a drug marketed by Bayer Hlthcare and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

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

Summary for AVELOX

US Patents:	1
Applicants:	1
NDAs:	2
Suppliers / Packagers:	7
Bulk Api Vendors:	85
Clinical Trials:	38
Patent Applications:	813
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AVELOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AVELOX
DailyMed Link:	AVELOX at DailyMed

Pharmacology for AVELOX

Ingredient-type	Quinolones
Drug Class	Quinolone Antimicrobial

Synonyms for AVELOX

(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 (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

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)

US Patents and Regulatory Information for AVELOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999	AB	RX	Yes	Yes			Y
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;IV (INFUSION)	021277-001	Nov 30, 2001		DISCN	Yes	No
Bayer Hlthcare	AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999	AB	RX	Yes	Yes
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;IV (INFUSION)	021277-001	Nov 30, 2001		DISCN	Yes	No			Y

Expired US Patents for AVELOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999
Bayer Hlthcare	AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999
Bayer Hlthcare	AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999

Paragraph IV (Patent) Challenges for AVELOX

Drugname	Dosage	Strength	RLD	Date
	Injection	1.6 mg/mL

International Patents for AVELOX

Country	Document Number	Estimated Expiration
Hong Kong	1042245
Honduras	1999000183
South Africa	200103141
Uruguay	25792
Canada	2349161
Australia	745282

Supplementary Protection Certificates for AVELOX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00111	Netherlands		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		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	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-CHINOLINKARBOKSIRûGðTIES HIDROCHLORIDAS)
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
/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