MOXIFLOXACIN HYDROCHLORIDE - Generic Drug Details

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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, Adaptis, Alembic, Apotex, Epic Pharma Llc, Eugia Pharma, Gland Pharma Ltd, 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, Natco, 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:	23
NDAs:	26
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	35
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	486
Patent Applications:	2,409
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
Madras Medical College	Phase 3
All India Institute of Medical Sciences, Jodhpur	Phase 3
Rural Development Trust Hospital	Phase 3

See all MOXIFLOXACIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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

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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
Lupin Ltd	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	204079-001	May 28, 2015		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	202867-001	Sep 4, 2014	AT1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	202916-001	Nov 9, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	208778-001	Mar 30, 2020	AT1	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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
Chartwell Rx	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	TABLET;ORAL	207285-001	Feb 13, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	MOXIFLOXACIN HYDROCHLORIDE	moxifloxacin hydrochloride	TABLET;ORAL	204836-001	Mar 2, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ 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 MOXIFLOXACIN HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER	moxifloxacin hydrochloride	SOLUTION;INTRAVENOUS	021277-001	Nov 30, 2001	⤷ Sign Up	⤷ Sign Up
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	⤷ Sign Up	⤷ Sign Up
Harrow Eye	VIGAMOX	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	021598-001	Apr 15, 2003	⤷ Sign Up	⤷ Sign Up
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999	⤷ Sign Up	⤷ Sign Up
Harrow Eye	MOXEZA	moxifloxacin hydrochloride	SOLUTION/DROPS;OPHTHALMIC	022428-001	Nov 19, 2010	⤷ Sign Up	⤷ Sign Up
Bayer Hlthcare	AVELOX	moxifloxacin hydrochloride	TABLET;ORAL	021085-001	Dec 10, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for MOXIFLOXACIN HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2299974	COMPOSITIONS PHARMACEUTIQUES CONTENANT UN MÉDICAMENT ANTIBIOTIQUE DE FLUOROQUINOLONE (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG)	⤷ Sign Up
China	104814961	Pharmaceutical compositions 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
China	103550141	Pharmaceutical compositions containing a fluoroquinolone antibiotic drug	⤷ Sign Up
Australia	2009257778	Pharmaceutical compositions containing a fluoroquinolone antibiotic drug	⤷ Sign Up
Taiwan	201503909	Improved pharmaceutical compositions containing a fluoroquinolone antibiotic drug	⤷ Sign Up
Uruguay	31880	COMPOSICIONES FARMACÉUTICAS MEJORADAS QUE CONTIENEN UN MEDICAMENTO ANTIBIÓTICO DE FLUOROQUINOLONA	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MOXIFLOXACIN HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2001C/030	Belgium	⤷ Sign Up	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	⤷ 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
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
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,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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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