Multaq is a drug owned by Sanofi Aventis Us Llc. It is protected by 6 US drug patents filed from 2013 to 2015. Out of these, 3 drug patents are active and 3 have expired. Multaq's patents have been open to challenges since 01 July, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 30, 2031. Details of Multaq's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8602215 | Methods for reducing the risk of an adverse dronedarone/beta-blockers interaction in a patient suffering from atrial fibrillation |
Jun, 2031
(6 years from now) | Active |
| US8410167 | Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality |
Apr, 2029
(4 years from now) | Active |
| US9107900 | Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of morality |
Apr, 2029
(4 years from now) | Active |
| US7323493 | Solid pharmaceutical composition containing benzofuran derivatives |
Jun, 2018
(6 years ago) |
Expired
|
| US8318800 | Solid pharmaceutical compositions containing benzofuran derivatives |
Jun, 2018
(6 years ago) |
Expired
|
| US5223510 | Alkylaminoalkyl derivatives of benzofuran, benzothiophene, indole and indolizine, process for their preparation and compositions containing them |
Jul, 2016
(8 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Multaq's patents.
Latest Legal Activities on Multaq's Patents
Given below is the list of recent legal activities going on the following patents of Multaq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Feb, 2023 | US9107900 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 May, 2021 | US8602215 |
| Expire Patent Critical | 04 Jan, 2021 | US8318800 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 17 Sep, 2020 | US8410167 |
| Maintenance Fee Reminder Mailed Critical | 20 Jul, 2020 | US8318800 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Feb, 2019 | US9107900 |
| Application ready for PDX access by participating foreign offices Critical | 31 Aug, 2015 | US9107900 |
| Patent Issue Date Used in PTA Calculation Critical | 18 Aug, 2015 | US9107900 |
| Recordation of Patent Grant Mailed Critical | 18 Aug, 2015 | US9107900 |
| Email Notification Critical | 30 Jul, 2015 | US9107900 |
FDA has granted several exclusivities to Multaq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Multaq, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Multaq.
Exclusivity Information
Multaq holds 1 exclusivities. All of its exclusivities have expired in 2014. Details of Multaq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 01, 2014 |
US patents provide insights into the exclusivity only within the United States, but Multaq is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Multaq's family patents as well as insights into ongoing legal events on those patents.
Multaq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Multaq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 30, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Multaq Generic API suppliers:
Dronedarone Hydrochloride is the generic name for the brand Multaq. 1 company has already filed for the generic of Multaq. Check out the entire list of companies who have already received approval for Multaq's generic
How can I launch a generic of Multaq before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Multaq's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Multaq's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Multaq -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 400 mg | 01 Jul, 2013 | 7 | 16 Apr, 2029 |
About Multaq
Multaq is a drug owned by Sanofi Aventis Us Llc. It is used for the management and treatment of atrial fibrillation in patients with risk factors such as coronary heart disease. Multaq uses Dronedarone Hydrochloride as an active ingredient. Multaq was launched by Sanofi Aventis Us in 2009.
Approval Date:
Multaq was approved by FDA for market use on 01 July, 2009.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Multaq is 01 July, 2009, its NCE-1 date is estimated to be 01 July, 2013.
Active Ingredient:
Multaq uses Dronedarone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Dronedarone Hydrochloride ingredient
Treatment:
Multaq is used for the management and treatment of atrial fibrillation in patients with risk factors such as coronary heart disease.
Dosage:
Multaq is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 400MG BASE | TABLET | Prescription | ORAL |