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Last Updated: October 24, 2021

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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 Novartis, Akorn, Alembic Pharms Ltd, Apotex, Aurobindo Pharma Ltd, Gland Pharma Ltd, Lupin Ltd, Mylan, Upsher Smith Labs, Watson Labs Inc, Bayer Hlthcare, Fresenius Kabi Usa, Mylan Labs Ltd, Crossmedika Sa, Dr Reddys Labs Ltd, 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 eighteen drug master file entries for moxifloxacin hydrochloride. Thirty-one 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
Rhythm Pharmaceuticals, Inc.Phase 4
Astex Pharmaceuticals, Inc.Phase 1
Taisho Pharmaceutical Co., Ltd.Phase 1

See all moxifloxacin hydrochloride clinical trials

Generic filers with tentative approvals for MOXIFLOXACIN HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever 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
Lupin Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 202867-001 Sep 4, 2014 AT1 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Crossmedika Sa MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 205348-001 Jan 14, 2016 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lupin Ltd MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride SOLUTION/DROPS;OPHTHALMIC 204079-001 May 28, 2015 AT2 RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Novel Labs Inc MOXIFLOXACIN HYDROCHLORIDE moxifloxacin hydrochloride TABLET;ORAL 207285-001 Feb 13, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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

Supplementary Protection Certificates for moxifloxacin hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0350733 SPC/GB03/034 United Kingdom ⤷  Free Forever 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
0350733 C300111 Netherlands ⤷  Free Forever 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 11/2000 Austria ⤷  Free Forever 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
0780390 PA2004012,C0780390 Lithuania ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
Medtronic
Boehringer Ingelheim
McKesson
Dow

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