You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 18, 2024

Details for New Drug Application (NDA): 022425


✉ Email this page to a colleague

« Back to Dashboard


NDA 022425 describes MULTAQ, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from two suppliers. There are three 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. Two suppliers are listed for this compound. Additional details are available on the dronedarone hydrochloride profile page.
Summary for 022425
Tradename:MULTAQ
Applicant:Sanofi Aventis Us
Ingredient:dronedarone hydrochloride
Patents:3
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 0024-4142-06 8 BLISTER PACK in 1 BOX (0024-4142-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK
MULTAQ dronedarone hydrochloride TABLET;ORAL 022425 NDA sanofi-aventis U.S. LLC 0024-4142 0024-4142-60 60 TABLET, FILM COATED in 1 BOTTLE (0024-4142-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Jul 1, 2009TE:ABRLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Apr 16, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS
Patent:⤷  Try a TrialPatent Expiration:Apr 16, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH MORNING AND EVENING MEALS
Patent:⤷  Try a TrialPatent Expiration:Jun 30, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF RISK OF DRONEDARONE/BETA-BLOCKER INTERACTION IN PATIENTS IN SINUS RHYTHM WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF

Expired US Patents for NDA 022425

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us MULTAQ dronedarone hydrochloride TABLET;ORAL 022425-001 Jul 1, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.