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Serving hundreds of leading biopharmaceutical companies globally:

Dow
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Generated: August 20, 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
Generic Entry Opportunity Date for 021883
Generic Entry Date for 021883*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
Dosage:
POWDER;IV (INFUSION)

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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;INTRAVENOUS 021883 NDA Durata Therapeutics Inc. 57970-100 N 57970-100-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;INTRAVENOUSStrengthEQ 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:

Cerilliant
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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.