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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Cipla
Express Scripts
Fish and Richardson
AstraZeneca
Chinese Patent Office
Daiichi Sankyo
Argus Health
Baxter

Generated: May 22, 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 is one patent 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-two 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:1
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 E 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 N 50419-537-01

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;IV (INFUSION)Strength400MG/250ML (1.6MG/ML)
Approval Date:Nov 30, 2001TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 27, 2019
Regulatory Exclusivity Use:UPDATES TO THE LABELING TO INCLUDE RESULTS OF A TRIAL TO EVALUATE THE SAFETY OF MOXIFLOXACIN IN PEDIATRIC PATIENTS WITH COMPLICATED INTRA-ABDOMINAL INFECTIONS
Patent:➤ Sign UpPatent 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 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;IV (INFUSION) 021277-001 Nov 30, 2001 ➤ Sign Up ➤ Sign Up
Bayer Hlthcare AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER moxifloxacin hydrochloride SOLUTION;IV (INFUSION) 021277-001 Nov 30, 2001 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Healthtrust
Fuji
Julphar
Mallinckrodt
Daiichi Sankyo
Merck
Harvard Business School
Dow

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