MOXIFLOXACIN HYDROCHLORIDE - Generic Drug Details

What are the generic 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-four 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:	34
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

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
Indoco	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	202525-001	Mar 6, 2015	AT1	RX	No	No
Sunshine	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	TABLET;ORAL	206295-001	Sep 28, 2018		DISCN	No	No
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010		DISCN	Yes	No			Y

Expired US Patents for MOXIFLOXACIN HYDROCHLORIDE

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
Bayer Hlthcare	AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999

International Patents for MOXIFLOXACIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
China	103550141	Pharmaceutical compositions containing a fluoroquinolone antibiotic drug
Argentina	072071	COMPOSICIONES FARMACEUTICAS MEJORADAS QUE CONTIENEN UNA DROGA ANTIBIOTICO DE FLUOROQUINOLONA
Taiwan	I544934

Supplementary Protection Certificates for MOXIFLOXACIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0350733	SPC/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
0780390	PA2004012	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)
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