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Last Updated: July 6, 2020

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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 Novartis, Akorn, Alembic Pharms Ltd, Apotex, Aurobindo Pharma Ltd, Gland Pharma Ltd, Lupin Ltd, Mylan, Watson Labs Inc, Bayer Hlthcare, Fresenius Kabi Usa, Mylan Labs Ltd, Crossmedika Sa, Dr Reddys Labs Ltd, MSN, Novel Labs Inc, Sunshine Lake, Teva Pharms Usa, and Torrent, and is included in twenty-four NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Moxifloxacin hydrochloride has one hundred and forty-three patent family members in forty-one countries.

There are eighteen drug master file entries for moxifloxacin hydrochloride. Twenty-eight 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
SunovionPhase 1
Ophthalmic Consultants of the Capital RegionPhase 4
Kyowa Kirin Co., Ltd.Phase 1

See all moxifloxacin hydrochloride clinical trials

Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start 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 NDA Submissiondate
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER SOLUTION;INTRAVENOUS moxifloxacin hydrochloride 021277 2014-02-07
MOXEZA SOLUTION/DROPS;OPHTHALMIC moxifloxacin hydrochloride 022428 2012-02-29
VIGAMOX SOLUTION/DROPS;OPHTHALMIC moxifloxacin hydrochloride 021598 2005-12-22
AVELOX TABLET;ORAL moxifloxacin hydrochloride 021085

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
Novartis VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003 AT1 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010 AT2 RX Yes Yes   Start Trial   Start Trial   Start Trial
Apotex MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 090080-001 Jun 30, 2017 AT1 RX No No   Start Trial   Start Trial   Start Trial
Novartis VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003 AT1 RX Yes Yes   Start Trial   Start Trial   Start Trial
Lupin Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 202867-001 Sep 4, 2014 AT1 RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 204079-001 May 28, 2015 AT2 RX No No   Start Trial   Start Trial   Start Trial
Akorn MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 202916-001 Nov 9, 2017 AT1 RX No No   Start Trial   Start Trial   Start 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
Novartis VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003   Start Trial   Start Trial
Novartis MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010   Start Trial   Start Trial
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999   Start Trial   Start Trial
Novartis VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003   Start Trial   Start Trial
Novartis MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010   Start Trial   Start Trial
Novartis MOXEZA moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 022428-001 Nov 19, 2010   Start Trial   Start Trial
Novartis VIGAMOX moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 021598-001 Apr 15, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for moxifloxacin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0350733 C300111 Netherlands   Start 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
0780390 PA2004012,C0780390 Lithuania   Start 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 2001C/030 Belgium   Start 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
0350733 11/2000 Austria   Start 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 SPC/GB03/034 United Kingdom   Start 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   Start 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)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Merck
Mallinckrodt
Harvard Business School
Medtronic
Johnson and Johnson

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