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AVELOX Drug Patent 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.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Avelox

A generic version of AVELOX was approved as moxifloxacin hydrochloride by TEVA PHARMS USA on February 18^th, 2014.

Summary for AVELOX

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	175
Clinical Trials:	48
Patent Applications:	5,276
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AVELOX
What excipients (inactive ingredients) are in AVELOX?	AVELOX excipients list
DailyMed Link:	AVELOX at DailyMed

See drug prices for AVELOX

See drug sales revenues for AVELOX

Recent Clinical Trials for AVELOX

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

Sponsor	Phase
SAMI Pharmaceutical, Karachi Pakistan	Phase 1
University of Karachi	Phase 1
Center for Bioequivalence Studies and Clinical Research	Phase 1

See all AVELOX clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for AVELOX

J01MA	Fluoroquinolones
J01M	QUINOLONE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for AVELOX

Tradename	Dosage	Ingredient	NDA	Submissiondate
AVELOX	TABLET;ORAL	moxifloxacin hydrochloride	021085

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		DISCN	Yes	No
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001		DISCN	Yes	No

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

International Patents for AVELOX

Country	Patent Number	Estimated Expiration
Australia	6055694
Argentina	005009
Russian Federation	2230555

Supplementary Protection Certificates for AVELOX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0780390	PA2004012,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
0350733	C300111	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
0350733	300111	Netherlands