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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Accenture
AstraZeneca
Julphar
Farmers Insurance
Chubb
Baxter
Merck
Deloitte

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021883

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NDA 021883 describes DALVANCE, which is a drug marketed by Allergan Sales Llc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the DALVANCE profile page.

The generic ingredient in DALVANCE is dalbavancin hydrochloride. One supplier is listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.
Summary for 021883
Tradename:DALVANCE
Applicant:Allergan Sales Llc
Ingredient:dalbavancin hydrochloride
Patents:4
Pharmacology for NDA: 021883
Ingredient-typeLipoglycopeptides
Suppliers and Packaging for NDA: 021883
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DALVANCE dalbavancin hydrochloride POWDER;IV (INFUSION) 021883 NDA Durata Therapeutics Inc. 57970-100 N 57970-100-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 500MG BASE/VIAL
Approval Date:May 23, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 20, 2019
Regulatory Exclusivity Use:ADDITION OF A 1500MG-SINGLE-DOSE REGIMEN FOR THE TREATMENT OF ADULT PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSI)
Regulatory Exclusivity Expiration:May 23, 2024
Regulatory Exclusivity Use:GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:May 23, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
Medtronic
McKesson
Express Scripts
UBS
US Army
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Harvard Business School

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