MOXEZA Drug Patent Profile

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Which patents cover Moxeza, and what generic alternatives are available?

Moxeza is a drug marketed by Harrow Eye and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-three patent family members in fifteen countries.

The generic ingredient in MOXEZA 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Moxeza

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

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Summary for MOXEZA

International Patents:	23
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	1
Patent Applications:	1,594
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MOXEZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MOXEZA
What excipients (inactive ingredients) are in MOXEZA?	MOXEZA excipients list
DailyMed Link:	MOXEZA at DailyMed

Drug patent expirations by year for MOXEZA

Recent Clinical Trials for MOXEZA

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

Sponsor	Phase
Usona Institute	Phase 1

See all MOXEZA clinical trials

Paragraph IV (Patent) Challenges for MOXEZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOXEZA	Ophthalmic Solution	moxifloxacin hydrochloride	0.5%	022428	1	2012-02-29

US Patents and Regulatory Information for MOXEZA

MOXEZA is protected by two US patents.

Patents protecting MOXEZA

Pharmaceutical compositions containing a fluoroquinolone antibiotic drug
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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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 MOXEZA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	⤷ Sign Up	⤷ Sign Up
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	⤷ Sign Up	⤷ Sign Up
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	⤷ Sign Up	⤷ Sign Up
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for MOXEZA

See the table below for patents covering MOXEZA around the world.

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Country	Patent Number	Title	Estimated Expiration
Ireland	970856		⤷ Sign Up
Austria	292127		⤷ Sign Up
South Korea	20110039219	PHARMACEUTICAL COMPOSITIOS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG	⤷ Sign Up
Chile	2009001379	Composicion acuosa farmaceutica que comprende moxifloxacino y un vehiculo que incluye cloruro de sodio, un surfactante que es un alcohol polieter y un agente polisacarido potenciador de la viscosidad que comprende goma xantan; util como composición oftalmica.	⤷ Sign Up
South Africa	8905366		⤷ Sign Up
World Intellectual Property Organization (WIPO)	0189496		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MOXEZA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0350733	SPC/GB03/034	United Kingdom	⤷ Sign Up	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	⤷ Sign Up	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-CHINOLINKARBOKSIRÃ»GÃ°TIES HIDROCHLORIDAS)
0350733	C300111	Netherlands	⤷ Sign Up	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
0780390	PA2004012,C0780390	Lithuania	⤷ Sign Up	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	300111	Netherlands	⤷ Sign Up
0350733	11/2000	Austria	⤷ Sign Up	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