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Moxifloxacin hydrochloride - Generic Drug Details

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Moxifloxacin hydrochloride is the generic ingredient in five branded drugs marketed by Watson Labs Inc, Alcon Pharms Ltd, Aurobindo Pharma Ltd, Mylan Pharms Inc, Teva Pharms Usa, Dr Reddys Labs Ltd, Crossmedika Sa, Torrent Pharms Ltd, Lupin Ltd, Fresenius Kabi Usa, and Bayer Hlthcare, and is included in fourteen NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and sixty patent family members in forty-seven countries.

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

Summary for Generic Name: moxifloxacin hydrochloride

Tradenames:5
Patents:7
Applicants:11
NDAs:14
Drug Master File Entries: see list18
Suppliers / Packaging: see list23
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: moxifloxacin hydrochloride

Ingredient-typeQuinolones
Drug ClassQuinolone Antimicrobial

Tentative approvals for MOXIFLOXACIN HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; OPHTHALMIC0.5%
<disabled><disabled>SOLUTION; OPHTHALMIC0.5%
<disabled><disabled>TABLET;ORAL400MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
AVELOX
moxifloxacin hydrochloride
TABLET;ORAL021085-001Dec 10, 1999RXYes► subscribe► subscribe
Lupin Ltd
MOXIFLOXACIN HYDROCHLORIDE
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC204079-001May 28, 2015RXNo► subscribe► subscribe
Watson Labs Inc
MOXIFLOXACIN HYDROCHLORIDE
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC202525-001Mar 6, 2015RXNo► subscribe► 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
Alcon Pharms Ltd
MOXEZA
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC022428-001Nov 19, 20104,990,517*PED► subscribe
Alcon Pharms Ltd
MOXEZA
moxifloxacin hydrochloride
SOLUTION/DROPS;OPHTHALMIC022428-001Nov 19, 20105,607,942*PED► subscribe
Bayer Hlthcare
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
moxifloxacin hydrochloride
SOLUTION;IV (INFUSION)021277-001Nov 30, 20014,990,517► subscribe
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International Patent Family for Ingredient: moxifloxacin hydrochloride

Country Document Number Estimated Expiration
Estonia9600201► subscribe
Slovakia285650► subscribe
El Salvador1999000194► 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
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
2004012,C0780390Lithuania► 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-CHINOLINKARBOKSIRUGSTIES HIDROCHLORIDAS); REGISTRATION NO/DATE: 04/8383/3 20040309
/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
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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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