Multaq Generic: When Will Generic Dronedarone Be Available?
This page is aggregated from FDA records, court filings and company announcements. Coded and designed by Dr. Brian Staiger, PharmD, BCPS
Updated October 9, 2026 How we build our data
Multaq Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? January to June 2029 A 6-month window Why then?
- Has the FDA approved a generic? January 2024 Since discontinued Why not yet?
- When does the last patent end? June 2031 3 patents listed with the FDA Why is a generic expected sooner?
- Can you buy a generic today? Not yet No company lists one for sale
Generic dronedarone hydrochloride is expected to be available between January and June 2029. None is for sale yet.
Why January to June 2029?
The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. We rate it probable: more likely than not, but it can still move.
If Multaq’s last patent runs to June 2031, how can a generic come sooner?
The patent that runs to June 2031 (8,602,215) covers a way of using it. A patent like that protects one way of making or using the medicine, not the medicine itself. A generic company can often make its version a different way or leave that use off its label, or a court can rule the patent invalid or not infringed. Here, a settlement between the companies sets the date. Generic companies have been challenging Multaq’s patents with the FDA since July 2013. That is why the expected month comes before the last protection ends. See the road to a generic
Why hasn’t the FDA approved a generic yet?
That is normal before a launch. The FDA usually can’t give a generic its final approval while a patent or exclusivity still blocks it, so final approval often comes close to the day the generic can be sold. 4 companies already hold a “tentative” approval, the FDA’s word for a generic that is ready but still blocked: Alkem Labs Ltd (December 2015), Glenmark Generics (December 2015), Watson Labs Inc (December 2015) and 1 more. See who is lined up
Will the generic cost less?
Usually, and more so as more companies sell one. 12 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $13.19 pharmacies pay per tablet for Multaq today to under $0.66. See the price estimate
What should I do now?
Keep taking Multaq as prescribed. When a generic arrives, your pharmacy may switch you to it automatically, and it may look different. What a generic means for you
Our month is only an estimate based on available information, so we never name a day.
Multaq by the Numbers
- Reason
- Settlement between companiesThe brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- Very strong 12 companies have filed, 8 first in line
- Brand sales
- $589M a yearBig seller
- FDA approved 2009 July 2009 FDA Orange Book
- Patents listed 3 last runs to June 2031 A generic is expected sooner, between January and June 2029. See why FDA Orange Book
- Pharmacies pay $13.19 per tablet, up 3.4% in a year NADAC, October 2026
- Medicare Part D spent $440.2M in 2025, for 72.4K people CMS Part D Spending by Drug
- Medicaid prescriptions 10.5K in the last four reported quarters, $10.7M CMS Medicaid drug utilization, to Q1 2026
Multaq’s Road to a Generic
Multaq has had the market to itself since the FDA approved it in July 2009 (Sanofi Aventis US LLC). Its 3 listed patents run to June 2031. Generic companies have challenged its patents with the FDA since July 2013.
The first generic of Multaq is expected between January and June 2029.
Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch.
Why a Generic Can Come Before June 2031
The last listed patent runs to June 2031, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge. Dr. Brian explains
Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.
Multaq Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Multaq’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,410,167 | A way of using it (U-1387, U-1388) | April 2029 | Active |
| 9,107,900 | A way of using it (U-1728, U-1726) | April 2029 | Active |
| 8,602,215 | A way of using it (U-1473) | June 2031 | Active |
Source: FDA Orange Book, application 022425. Patent numbers open the patent on Google Patents.
Patent Challenges to Multaq
The first patent challenge to Multaq reached the FDA in July 2013, from 7 companies on that first day. The FDA approved a first challenger’s generic in January 2024, and the list records no sale by a first challenger yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Multaq’s patents run out can tell the FDA that a patent is invalid, or that its version does not infringe it. The FDA calls this a “Paragraph IV certification.” The brand company usually sues, and the FDA then generally cannot approve that generic for up to 30 months while the case runs. To reward going first, the companies that challenge first can get a 180-day head start: the FDA cannot approve the generics that came after them until it ends.
| Product | First challenged | Companies that day | 180-day head start | First challenger’s generic | Challenged patents run to | |
|---|---|---|---|---|---|---|
| Approved | On sale | |||||
| Tablets, 400 mg | July 2013 | 7 companies | First challenger eligible decided February 2024 | January 2024 | Not yet | April 2029 |
Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.
Who Is Lined Up to Make Generic Dronedarone Hydrochloride
Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.
Applied to the FDA
12 companies have applied to the FDA to make generic dronedarone hydrochloride.
The FDA has tentatively approved 4 companies’ generics, listed below. A tentative approval means the generic is ready, but a patent or exclusivity still stops the FDA from giving it final approval.
The FDA keeps the other applications private until it acts on them, so those companies are not named here.
First in line. 8 of them were first in line, all filing on the first day any company did: they can share 180 days on the market before the other generics, which is why being first matters.
Generic companies have challenged Multaq’s patents with the FDA since July 2013: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic dronedarone hydrochloride. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic dronedarone hydrochloride for sale with the FDA.
| Company | Tentatively approved |
|---|---|
| Alkem Labs Ltd | December 2015 |
| Glenmark Generics | December 2015 |
| Watson Labs Inc | December 2015 |
| Sandoz Inc | May 2021 |
| Company | First approved | Strengths | Rated |
|---|---|---|---|
| Lupin Inc discontinued | January 2024 | EQ 400MG BASE | – |
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Multaq Price: What Pharmacies Pay and What Generics Usually Do
What Pharmacies Pay for Multaq 400 mg tablet
$13.19 per tablet in October 2026, up 3.4% from a year earlier.
Hover over or tap anywhere on the chart to see that month’s price.
See the numbers
| Month | Pharmacies paid per tablet |
|---|---|
| October 2026 | $13.19 |
| September 2026 | $13.19 |
| August 2026 | $13.19 |
| July 2026 | $13.19 |
| June 2026 | $13.19 |
| May 2026 | $13.20 |
| April 2026 | $13.19 |
| March 2026 | $13.19 |
| February 2026 | $13.19 |
| January 2026 | $13.19 |
| February 2024 | $12.76 |
| January 2024 | $12.76 |
NADAC: the national average price retail pharmacies pay to buy the medicine (CMS survey, updated weekly), the last price of each month for one package. It is not what you pay: that depends on your insurance or discount card.
What a Generic Could Cost
How we estimate it. We start from what pharmacies pay for Multaq today: $13.19 per tablet for Multaq 400 mg tablet in October 2026, from the national NADAC survey. Then we apply the FDA’s finding of how far that price usually falls as generic companies join: about 31% with one company, 44% with two, 73% with four and over 95% with six or more (the typical drop for every drug whose first generic came out from 2015 to 2017). Multaq has 12 companies lined up, so our estimate uses the figure for six or more companies. More companies would bring the price lower; fewer, less of a drop.
Dollar figures apply FDA’s median drops to the $13.19 pharmacies pay per tablet today. An estimate from the pattern, not a price quote: what you pay depends on your insurance or discount card.
Median prices pharmacies paid for the generic (invoice prices), compared with the brand’s price before generic entry, from FDA’s 2019 analysis “Generic Competition and Drug Prices”. At the manufacturer’s price FDA found steeper drops (about 39%, 54%, 79% and over 95%), the figures quoted elsewhere on this tracker. A typical pattern, not a price quote for this medicine.
What Medicare and Medicaid Spend on Multaq
Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.
Medicare Part D Spending
What Medicare drug plans spent on Multaq, before manufacturer rebates.
- $100.2M
- January to March 2026, the latest CMS has posted
For 46,498 people, about $1,397 per prescription fill - $440.2M
- 2025, the whole year
For 72,363 people, about $1,379 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $100,198,891 | 46,498 | $1,396.62 |
| 2025 | $440,196,258 | 72,363 | $1,379.27 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Multaq only, so no generic is counted in it. What CMS says it is used for: This medication is used if you have had certain types of irregular heartbeat (paroxysmal or persistent atrial fibrillation) in the past but now have a normal heart rhythm. It helps you keep a normal heart rhythm and lowers your chance of having to go to the hospital for atrial fibrillation.
Medicaid Prescriptions by Quarter
10,541 prescriptions in the four quarters to Q1 2026, $10.7M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 2,374 | $2,505,932 |
| Q4 2025 | 2,600 | $2,677,297 |
| Q3 2025 | 2,763 | $2,744,673 |
| Q2 2025 | 2,804 | $2,813,583 |
| Q1 2025 | 2,850 | $2,821,781 |
Source: CMS Medicaid State Drug Utilization Data, over Multaq’s own package codes.
Multaq Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 400MG BASE | Tablet | Oral | July 2009 | Prescription reference product |
Source: FDA Orange Book, Sanofi Aventis US LLC. Listed for sale today by sanofi-aventis U.S. LLC, Cardinal Health and Cardinal Health 107, LLC (FDA NDC Directory).
Multaq NDC Codes and Packages
Each Multaq package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.
| NDC | Product | Package | Company |
|---|---|---|---|
| 00024-4142-00 | DRONEDARONE 400 mg/1 tablet, film coated | blister pack of 6 tablets | Sanofi-Aventis U.S. LLC |
| 00024-4142-06 | DRONEDARONE 400 mg/1 tablet, film coated | box of 8 blister packs of 6 tablets | Sanofi-Aventis U.S. LLC |
| 00024-4142-06 | DRONEDARONE 400 mg/1 tablet, film coated | box of 8 blister packs of 6 tablets | Sanofi-Aventis U.S. LLC |
| 00024-4142-60 | DRONEDARONE 400 mg/1 tablet, film coated | bottle of 60 tablets | Sanofi-Aventis U.S. LLC |
| 00024-4142-60 | DRONEDARONE 400 mg/1 tablet, film coated | bottle of 60 tablets | Sanofi-Aventis U.S. LLC |
| 55154-8104-02 | DRONEDARONE 400 mg/1 tablet, film coated | bottle of 1,260 tablets | Cardinal Health 107, LLC |
| 55154-8104-02 | DRONEDARONE 400 mg/1 tablet, film coated | bottle of 1,260 tablets | Cardinal Health 107, LLC |
Source: the FDA NDC Directory, current listings only. Only packages sold under Multaq’s own FDA approval (NDA 22425) are listed, never a generic. Some codes belong to companies that repackage Multaq: it is the same medicine in a different package.
What a Generic Multaq Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Multaq as usual. When one arrives, there is nothing you need to sign up for.
Your Pharmacy May Switch You Automatically
Every state lets pharmacists fill a brand-name prescription with an FDA-approved generic rated as equivalent to it, and about 19 states require them to, unless your prescriber writes “dispense as written” or “brand medically necessary” on the prescription. Some states ask the pharmacist to tell you, or to get your OK first. A study of every state’s law has the details.
It Will Probably Look Different
US trademark law does not let a generic look exactly like the brand, so the color, shape or markings usually change. The active ingredient, strength and form are the same. An “authorized generic,” made by or for the brand’s own company, can look identical. The FDA explains.
Your Insurance May Change Too
Once a lower-cost version is available, many insurance plans charge more for the brand, or stop covering it. Your plan’s drug list (formulary) says how.
Until a generic is on US pharmacy shelves, be careful with websites that offer “generic Multaq”. The FDA warns that unlicensed online pharmacies sell counterfeit and unapproved medicines; its BeSafeRx page shows how to check a pharmacy.
Questions people ask about Multaq
Is there a generic for Multaq right now?
No. As of October 9, 2026 no generic dronedarone hydrochloride is listed for sale in the FDA NDC Directory. 1 generic version is FDA-approved (Orange Book), which usually means it is waiting on patents or on the maker’s own launch plans.
When will Multaq go generic?
January to June 2029 is the expected window, and that is probable but not certain. The brand company and a generic maker settled their patent fight and agreed on when a generic can launch. The last listed patent runs to June 2031, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic dronedarone hydrochloride be the same as Multaq?
Yes in the ways that matter: the same active ingredient, strength and form, with proof that it reaches your blood the same way. Inactive ingredients can differ, which is why some people notice a different look or taste.
How much will the generic cost?
Nobody can say for sure before launch. 12 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid over 95% less once six or more companies sold a generic, which would take the $13.19 pharmacies pay per tablet for Multaq today to under $0.66. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Multaq?
Not yet. The FDA Orange Book lists no approved generic version of Multaq that is still marketed.
When does the Multaq patent expire?
The FDA Orange Book lists 3 patents for Multaq; the last runs to June 2031. A patent date is not the launch date: settlements and court rulings often bring a generic earlier, and FDA approval or a company’s own plans can make it later. The expected window on this page (January to June 2029) weighs all of that.
Has anyone challenged the Multaq patents?
Yes. The first patent challenge to Multaq reached the FDA in July 2013, from 7 companies on that first day. The FDA approved a first challenger’s generic in January 2024, and the list records no sale by a first challenger yet. A patent challenge (a “Paragraph IV certification”) is a generic company telling the FDA that a patent listed for the brand is invalid or will not be infringed by its version. The first companies to file one can earn a 180-day head start, during which the FDA cannot approve the generics that filed after them.
How much does Multaq cost now?
Pharmacies paid about $13.19 per tablet for Multaq 400 mg tablet in October 2026, by the national survey of what pharmacies pay (NADAC). That is the pharmacy’s cost, not your price: what you pay depends on your insurance or discount card.
Changes to This Projection
- First generic expected January to June 2029 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.
Every change to the expected month is logged here with the month we saw it.
Also Going Generic
- Xartemis XRAcetaminophen and Oxycodone Hydrochloride2027 to 2028
- Kisqali Femara Co-PackLetrozole and RibociclibJuly to September 2031
- ErleadaApalutamide2035 to 2036
- BafiertamMonomethyl FumarateFebruary 2035
- SympazanClobazamJanuary 2040
- OrzeyfulOveporextonAugust 2040
About Multaq
- Generic name dronedarone hydrochloride
- How it is taken By mouth
- Company Sanofi Aventis US LLC
- Patent challenges Since July 2013 (FDA)
- More drugs Brand-name drugs starting with M
- Have a question? A pharmacist answers, free. Ask about Multaq
Sources. The expected month: FDA Paragraph IV Patent Certifications list, federal court records, company announcements and securities filings (settlement dates, launch plans, sales). The record on this page: FDA Orange Book, Drugs@FDA (tentative approvals), FDA NDC Directory, FDA Paragraph IV Patent Certifications list, NADAC (CMS), CMS Medicare Part D Spending by Drug, Medicaid State Drug Utilization Data, FDA, Generic Competition and Drug Prices (2019). Updated October 9, 2026. Information, not medical advice.