Moxeza Drug Patent Profile

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

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-five 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.

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

See drug prices for Moxeza

See drug sales revenues 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

Anatomical Therapeutic Chemical (ATC) Classes for Moxeza

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 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

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			Y
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010		DISCN	Yes	No			Y

Expired US Patents for Moxeza

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
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010

International Patents for Moxeza

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

Country	Patent Number	Title	Estimated Expiration
China	1184968
Uruguay	31880	COMPOSICIONES FARMACÉUTICAS MEJORADAS QUE CONTIENEN UN MEDICAMENTO ANTIBIÓTICO DE FLUOROQUINOLONA
Canada	2726616	COMPOSITIONS PHARMACEUTIQUES CONTENANT UN MEDICAMENT ANTIBIOTIQUE DE FLUOROQUINOLONE (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG)
European Patent Office	2269602	Compositions antibiotiques destinees au traitement des oreilles (Antibiotic compositions for treatment of the ear)
Austria	501732

Supplementary Protection Certificates for Moxeza

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0350733	300111	Netherlands
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	2001C/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
0350733	11/2000	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
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