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Last Updated: March 29, 2024

Moxifloxacin hydrochloride - Generic Drug Details


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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-four suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for moxifloxacin hydrochloride

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

SponsorPhase
Ministry of Health, FrancePhase 3
Assistance Publique Hopitaux De MarseillePhase 3
Hôpital Necker-Enfants MaladesPhase 3

See all moxifloxacin hydrochloride clinical trials

Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.5%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
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
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 021277-001 Nov 30, 2001 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chartwell Rx MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 207285-001 Feb 13, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Torrent MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 200160-001 Apr 3, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 206447-001 Mar 30, 2020 AT1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 202867-001 Sep 4, 2014 AT1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 204635-001 Aug 31, 2015 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

International Patents for moxifloxacin hydrochloride

Country Patent Number Title Estimated Expiration
South Korea 20110039219 PHARMACEUTICAL COMPOSITIOS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG ⤷  Try a Trial
Taiwan 201503909 Improved pharmaceutical compositions containing a fluoroquinolone antibiotic drug ⤷  Try a Trial
Japan 2011522823 ⤷  Try a Trial
China 104814961 Pharmaceutical compositions containing a fluoroquinolone antibiotic drug ⤷  Try a Trial
South Africa 201008543 PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG ⤷  Try a Trial
Argentina 072071 COMPOSICIONES FARMACEUTICAS MEJORADAS QUE CONTIENEN UNA DROGA ANTIBIOTICO DE FLUOROQUINOLONA ⤷  Try a Trial
Mexico 2010012933 COMPOSICIONES FARMACEUTICAS QUE CONTIENEN UNA DROGA ANTIBIOTICA DE FLUOROQUINOLONA. (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for moxifloxacin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0350733 SPC/GB03/034 United Kingdom ⤷  Try a Trial 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 ⤷  Try a Trial 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 C300111 Netherlands ⤷  Try a Trial 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 ⤷  Try a Trial PRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
0780390 PA2004012,C0780390 Lithuania ⤷  Try a Trial 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 11/2000 Austria ⤷  Try a Trial 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

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