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Last Updated: December 14, 2019

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AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER Drug Profile

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When do Avelox In Sodium Chloride 0.8% In Plastic Container patents expire, and what generic alternatives are available?

Avelox In Sodium Chloride 0.8% In Plastic Container is a drug marketed by Bayer Hlthcare and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-eight patent family members in thirty-seven countries.

The generic ingredient in AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Avelox In Sodium Chloride 0.8% In Plastic Container

A generic version of AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER was launched as moxifloxacin hydrochloride by TEVA PHARMS USA on December 14th, 2019.

Drug patent expirations by year for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Recent Clinical Trials for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

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

SponsorPhase
Cara Therapeutics, Inc.Phase 1
CelerionPhase 1
Wex Pharmaceuticals Inc.Phase 1

See all AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER clinical trials

Recent Litigation for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Identify potential future generic entrants

District Court Litigation
Case NameDate
Alcon Pharmaceuticals v. Teva Pharmaceuticals2009-12-02
Bayer Healthcare AG v. Teva Pharmaceuticals U.S.A., Inc.2007-04-05
Bayer AG v. Dr. Reddy's Lab.Ltd.2004-03-24

See all AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER litigation

Pharmacology for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Paragraph IV (Patent) Challenges for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Tradename Dosage Ingredient NDA Submissiondate
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER SOLUTION;INTRAVENOUS moxifloxacin hydrochloride 021277 2014-02-07

US Patents and Regulatory Information for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

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   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 021277-001 Nov 30, 2001 DISCN Yes 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 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

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   Start Trial   Start Trial
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 021277-001 Nov 30, 2001   Start Trial   Start Trial
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;INTRAVENOUS 021277-001 Nov 30, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
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)
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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