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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Novartis
Queensland Health
Daiichi Sankyo
Baxter
Cipla
Moodys
US Army
UBS
Chinese Patent Office

Generated: October 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022425

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NDA 022425 describes MULTAQ, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from four suppliers. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MULTAQ profile page.

The generic ingredient in MULTAQ is dronedarone hydrochloride. There are nineteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dronedarone hydrochloride profile page.

Summary for NDA: 022425

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:6
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022425

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MULTAQ
dronedarone hydrochloride
TABLET;ORAL 022425 NDA sanofi-aventis U.S. LLC 0024-4142 0024-4142-10 10 BLISTER PACK in 1 BOX (0024-4142-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK
MULTAQ
dronedarone hydrochloride
TABLET;ORAL 022425 NDA sanofi-aventis U.S. LLC 0024-4142 0024-4142-50 500 TABLET, FILM COATED in 1 BOTTLE (0024-4142-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Jul 1, 2009TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jul 26, 2016Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF THE RISK OF CARDIOVASCULAR HOSPITALIZATION
Patent:► SubscribePatent Expiration:Jul 26, 2016Product Flag?YSubstance Flag?YDelist Request?
Patented Use:REDUCTION OF THE RISK OF HOSPITALIZATION FOR ATRIAL FIBRILLATION
Patent:► SubscribePatent Expiration:Jun 19, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022425

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
MULTAQ
dronedarone hydrochloride
TABLET;ORAL022425-001Jul 1, 2009► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Teva
Chubb
Covington
Dow
Cantor Fitzgerald
US Army
Queensland Health
Moodys
Federal Trade Commission
Citi

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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