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Serving 500+ biopharmaceutical companies globally:

Colorcon
Express Scripts
Boehringer Ingelheim
Cerilliant
Chubb
Julphar
Fish and Richardson
Harvard Business School
Medtronic
Mallinckrodt

Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021883

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NDA 021883 describes DALVANCE, which is a drug marketed by Durata Theraps Intl 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 NDA: 021883

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1

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 57970-100-01 1 VIAL in 1 PACKAGE (57970-100-01) > 25 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;IV (INFUSION)StrengthEQ 500MG BASE/VIAL
Approval Date:May 23, 2014TE:RLD:Yes
Patent:7,115,564Patent Expiration:Nov 14, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:7,119,061Patent Expiration:Nov 14, 2023Product Flag?YSubstance Flag?Delist Request?
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)


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Serving 500+ biopharmaceutical companies globally:

Citi
Mallinckrodt
Farmers Insurance
Argus Health
Chinese Patent Office
Accenture
Moodys
Covington
Healthtrust
Cantor Fitzgerald

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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