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Serving 500+ biopharmaceutical companies globally:

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Generated: July 22, 2017

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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 moxifloxacin hydrochloride freedom to operate?

Moxifloxacin hydrochloride
is the generic ingredient in six branded drugs marketed by Watson Labs Inc, Novartis Pharms Corp, Aurobindo Pharma Ltd, Mylan Labs Ltd, Mylan Pharms Inc, Teva Pharms Usa, Dr Reddys Labs Ltd, Crossmedika Sa, Torrent Pharms Ltd, Lupin Ltd, Fresenius Kabi Usa, Bayer Hlthcare, Apotex Inc, and Novel Labs Inc, and is included in seventeen NDAs. There are eight 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 sixty-one patent family members in forty-seven countries.

There are eighteen drug master file entries for moxifloxacin hydrochloride. Twenty-seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: moxifloxacin hydrochloride

Tradenames:6
Patents:8
Applicants:14
NDAs:17
Drug Master File Entries: see list18
Suppliers / Packagers: see list27
Bulk Api Vendors: see list58
Clinical Trials: see list2,519
Patent Applications: see list1,067
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:moxifloxacin hydrochloride at DailyMed

Pharmacology for Ingredient: moxifloxacin hydrochloride

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Tentative approvals for MOXIFLOXACIN HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe0.5%SOLUTION; OPHTHALMIC
► Subscribe► Subscribe0.5%SOLUTION; OPHTHALMIC
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
MOXIFLOXACIN HYDROCHLORIDE
moxifloxacin hydrochloride
TABLET;ORAL204635-001Aug 31, 2015ABRXNoNo► Subscribe► Subscribe
Bayer Hlthcare
AVELOX
moxifloxacin hydrochloride
TABLET;ORAL021085-001Dec 10, 1999ABRXYesYes► Subscribe► Subscribe
Lupin Ltd
MOXIFLOXACIN HYDROCHLORIDE
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC202867-001Sep 4, 2014AT1RXNoNo► Subscribe► Subscribe
Bayer Hlthcare
AVELOX
moxifloxacin hydrochloride
TABLET;ORAL021085-001Dec 10, 1999ABRXYesYes6,610,327► SubscribeY ► Subscribe
Novartis Pharms Corp
MOXEZA
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC022428-001Nov 19, 2010AT2RXYesYes8,450,311► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: moxifloxacin hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare
AVELOX
moxifloxacin hydrochloride
TABLET;ORAL021085-001Dec 10, 19995,849,752► Subscribe
Bayer Hlthcare
AVELOX
moxifloxacin hydrochloride
TABLET;ORAL021085-001Dec 10, 19995,607,942► Subscribe
Novartis Pharms Corp
MOXEZA
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC022428-001Nov 19, 20104,990,517*PED► Subscribe
Bayer Hlthcare
AVELOX
moxifloxacin hydrochloride
TABLET;ORAL021085-001Dec 10, 19994,990,517► Subscribe
Bayer Hlthcare
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
moxifloxacin hydrochloride
SOLUTION;IV (INFUSION)021277-001Nov 30, 20015,849,752► Subscribe
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International Patent Family for Ingredient: moxifloxacin hydrochloride

Country Document Number Estimated Expiration
Slovenia1206281► Subscribe
Poland194020► Subscribe
Canada2192418► Subscribe
Australia1267400► Subscribe
Romania119782► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MOXIFLOXACIN HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2000Austria► SubscribePRODUCT 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
01C/030Belgium► SubscribePRODUCT NAME: MOXIFLOXACINE CHLORHYDRATE (CORRESPONDANT A MOXIFLOXACINE); NATL. REGISTRATION NO/DATE: 187 IS 328 F 3 20010507; FIRST REGISTRATION: DE 45263.00.00 19990621
00111Netherlands► SubscribePRODUCT 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
2004012Lithuania► SubscribePRODUCT 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)
C/GB03/034United Kingdom► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Covington
Johnson and Johnson
Accenture
Daiichi Sankyo
Citi
McKesson
Cipla
Colorcon
Healthtrust
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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