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Serving leading biopharmaceutical companies globally:

US Army
Fish and Richardson
Merck
Citi
McKesson
Fuji
Colorcon
UBS
Dow
Healthtrust

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021085

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NDA 021085 describes AVELOX, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. It is available from ten suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AVELOX profile page.

The generic ingredient in AVELOX is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 021085
Tradename:AVELOX
Applicant:Bayer Hlthcare
Ingredient:moxifloxacin hydrochloride
Patents:2
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 021085
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 021085
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085 NDA Schering Plough Corporation 0085-1733 0085-1733-03 5 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0085-1733-03)
AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085 NDA Schering Plough Corporation 0085-1733 0085-1733-02 50 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0085-1733-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Dec 10, 1999TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Sep 27, 2019
Regulatory Exclusivity Use:
Patent:➤ SubscribePatent Expiration:Dec 5, 2016Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF COMBATING BACTERIA IN A PATIENT
Patent:➤ SubscribePatent Expiration:Oct 29, 2019Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF COMBATING BACTERIA IN A PATIENT

Expired US Patents for NDA 021085

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999 ➤ Subscribe ➤ Subscribe
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999 ➤ Subscribe ➤ Subscribe
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Deloitte
Boehringer Ingelheim
Chubb
Fuji
Healthtrust
Julphar
Cerilliant
Covington

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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