Moxifloxacin hydrochloride - Generic Drug Details

What are the generic drug sources for moxifloxacin hydrochloride and what is the scope of freedom to operate?

Moxifloxacin hydrochloride is the generic ingredient in six branded drugs marketed by Harrow Eye, Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, Indoco, Lupin Ltd, Mylan, Upsher Smith Labs, Bayer Hlthcare, Fresenius Kabi Usa, Mylan Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Crossmedika Sa, Dr Reddys, Hetero Labs Ltd V, MSN, Sunshine, Teva Pharms Usa, and Torrent, and is included in twenty-six NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Moxifloxacin hydrochloride has twenty-three patent family members in fifteen countries.

There are seventeen drug master file entries for moxifloxacin hydrochloride. Thirty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for moxifloxacin hydrochloride

International Patents:	23
US Patents:	2
Tradenames:	6
Applicants:	22
NDAs:	26
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	474
Patent Applications:	2,409
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for moxifloxacin hydrochloride
What excipients (inactive ingredients) are in moxifloxacin hydrochloride?	moxifloxacin hydrochloride excipients list
DailyMed Link:	moxifloxacin hydrochloride at DailyMed

Recent Clinical Trials for moxifloxacin hydrochloride

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

Sponsor	Phase
Ministry of Health, France	Phase 3
Assistance Publique Hopitaux De Marseille	Phase 3
Hôpital Necker-Enfants Malades	Phase 3

See all moxifloxacin hydrochloride clinical trials

Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		0.5%	SOLUTION; OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for moxifloxacin hydrochloride

Drug Class

Fluoroquinolone Antibacterial Quinolone Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for moxifloxacin hydrochloride

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 MOXIFLOXACIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MOXEZA	Ophthalmic Solution	moxifloxacin hydrochloride	0.5%	022428	1	2012-02-29
VIGAMOX	Ophthalmic Solution/Drops	moxifloxacin hydrochloride	0.5%	021598	1	2005-12-22

US Patents and Regulatory Information for moxifloxacin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	209469-001	Feb 13, 2019	AT1	RX	No	No
Epic Pharma Llc	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	202916-001	Nov 9, 2017		DISCN	No	No
Fresenius Kabi Usa	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	205572-001	Apr 3, 2015		RX	Yes	Yes
Dr Reddys	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	TABLET;ORAL	076938-001	Mar 4, 2014	AB	RX	No	Yes

Expired US Patents for moxifloxacin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010

International Patents for moxifloxacin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Canada	2726616	COMPOSITIONS PHARMACEUTIQUES CONTENANT UN MEDICAMENT ANTIBIOTIQUE DE FLUOROQUINOLONE (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG)
Mexico	2010012933	COMPOSICIONES FARMACEUTICAS QUE CONTIENEN UNA DROGA ANTIBIOTICA DE FLUOROQUINOLONA. (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG.)
Taiwan	I544934
Australia	2009257778	Pharmaceutical compositions containing a fluoroquinolone antibiotic drug

Supplementary Protection Certificates for moxifloxacin hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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