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Last Updated: January 27, 2023

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 Imprimis Pharms Usa, Akorn, Alembic Pharms Ltd, Apotex, Eugia Pharma, Gland Pharma Ltd, Indoco, Lupin Ltd, Mylan, Upsher Smith Labs, Novartis, Bayer Hlthcare, Fresenius Kabi Usa, Mylan Labs Ltd, Aurobindo Pharma Ltd, Crossmedika Sa, Dr Reddys, MSN, Novel Labs Inc, Sunshine, Teva Pharms Usa, and Torrent, and is included in twenty-five 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-three 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
Stellah MpagamaPhase 3
University of St AndrewsPhase 3
Radboud University Medical CenterPhase 3

See all moxifloxacin hydrochloride clinical trials

Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing0.5%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
Upsher Smith Labs MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 212616-001 Feb 10, 2021 AT1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sunshine MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 206295-001 Sep 28, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Eugia Pharma MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 206242-001 Oct 4, 2017 AT1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Imprimis Pharms Usa MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010 AT2 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Fresenius Kabi Usa MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 205572-001 Apr 3, 2015 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alembic Pharms Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 209469-001 Feb 13, 2019 AT1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 204635-001 Aug 31, 2015 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Japan 5509201 See Plans and Pricing
South Africa 201008543 PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG See Plans and Pricing
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. See Plans and Pricing
Australia 2009257778 Pharmaceutical compositions containing a fluoroquinolone antibiotic drug See Plans and Pricing
Mexico 2010012933 COMPOSICIONES FARMACEUTICAS QUE CONTIENEN UNA DROGA ANTIBIOTICA DE FLUOROQUINOLONA. (PHARMACEUTICAL COMPOSITIONS CONTAINING A FLUOROQUINOLONE ANTIBIOTIC DRUG.) See Plans and Pricing
Brazil PI0914971 composições farmacêuticas que contêm fármaco antibiótico de fluoroquinolonas See Plans and Pricing
Uruguay 31880 COMPOSICIONES FARMACÉUTICAS MEJORADAS QUE CONTIENEN UN MEDICAMENTO ANTIBIÓTICO DE FLUOROQUINOLONA See Plans and Pricing
>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 See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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
0350733 11/2000 Austria See Plans and Pricing 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 See Plans and Pricing 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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