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Serving leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Queensland Health
Teva
Harvard Business School
Farmers Insurance
Healthtrust
Cipla
Covington
Fish and Richardson

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021277

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NDA 021277 describes AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER profile page.

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-four suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 021277
Tradename:AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
Applicant:Bayer Hlthcare
Ingredient:moxifloxacin hydrochloride
Patents:2
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details
Pharmacology for NDA: 021277
Ingredient-typeQuinolones
Suppliers and Packaging for NDA: 021277
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;IV (INFUSION) 021277 NDA Schering Plough Corporation 0085-1737 0085-1737-01 250 mL in 1 BAG (0085-1737-01)
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;IV (INFUSION) 021277 NDA Bayer HealthCare Pharmaceuticals Inc. 50419-537 50419-537-01 250 mL in 1 BAG (50419-537-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength400MG/250ML (1.6MG/ML)
Approval Date:Nov 30, 2001TE:APRLD: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:Jul 25, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF COMBATING BACTERIA IN A PATIENT

Expired US Patents for NDA 021277

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;IV (INFUSION) 021277-001 Nov 30, 2001 ➤ Subscribe ➤ Subscribe
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;IV (INFUSION) 021277-001 Nov 30, 2001 ➤ Subscribe ➤ Subscribe
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;IV (INFUSION) 021277-001 Nov 30, 2001 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Express Scripts
Dow
Cipla
Teva
Fuji
Chubb
UBS

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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