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Last Updated: March 28, 2024

MOXIFLOXACIN HYDROCHLORIDE - Generic Drug Details


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What are the generic sources for moxifloxacin hydrochloride and what is the scope of patent protection?

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
Centre Hospitalier Universitaire de CaenPhase 3
Institut PasteurPhase 3
Assistance Publique Hopitaux De MarseillePhase 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
Teva Pharms Usa MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 077437-001 Feb 18, 2014 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Crossmedika Sa MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 205348-001 Jan 14, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msn MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 208682-001 Sep 22, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 206242-001 Oct 4, 2017 AT1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

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 ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003 ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010 ⤷  Try a Trial ⤷  Try a Trial
Harrow Eye VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for MOXIFLOXACIN HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Taiwan I495469 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2009151974 ⤷  Try a Trial
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. ⤷  Try a Trial
Taiwan I544934 ⤷  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
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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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