Rezdiffra Generic: When Will Generic Resmetirom 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
Rezdiffra Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2042 to 2043 A wide window Why then?
- Has the FDA approved a generic? Not yet None in the FDA’s records yet Why not yet?
- When does the last patent end? February 2045 8 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 resmetirom is expected to be available between 2042 and 2043. None is for sale yet.
Why 2042 to 2043?
The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. We rate it probable: more likely than not, but it can still move.
If Rezdiffra’s last patent runs to February 2045, how can a generic come sooner?
The 2 patents that run past the expected month, to February 2045 (12,377,104 and 12,667,575), cover 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, the companies are expected to settle on a date. 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. No company holds a “tentative” approval yet either (the FDA’s word for a generic that is ready but still blocked).
Will the generic cost less?
Usually, but no company is recorded as having applied to make one yet, and a single company usually brings only a modest drop. See the price pattern
What should I do now?
Keep taking Rezdiffra 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.
Rezdiffra by the Numbers
- Reason
- Settlement expectedThe patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
- How sure
- Probable More likely than not, but it can still move.
- Price competition
- None filed yet No filers on record
- Brand sales
- $1.2B a yearBlockbuster
- FDA approved 2024 March 2024 FDA Orange Book
- Patents listed 8 last runs to February 2045 A generic is expected sooner, between 2042 and 2043. See why FDA Orange Book
- Medicare Part D spent $475.8M in 2025, for 17.6K people CMS Part D Spending by Drug
- Medicaid prescriptions 27.5K in the last four reported quarters, $121M CMS Medicaid drug utilization, to Q1 2026
Rezdiffra’s Road to a Generic
Rezdiffra has had the market to itself since the FDA approved it in March 2024 (Madrigal Pharmaceuticals Inc). Its FDA protection (new chemical entity) runs to March 2029. Its 8 listed patents run to February 2045.
The first generic of Rezdiffra is expected between 2042 and 2043.
Why that month: the patent fight is likely to end in an agreement that sets the launch. The terms are not public yet.
Why a Generic Can Come Before February 2045
The last listed patent runs to February 2045, 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.
Rezdiffra Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Rezdiffra’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 |
|---|---|---|---|
| 7,452,882 | The active ingredient; the product’s formulation | September 2027 | Active |
| 9,266,861 | The active ingredient; the product’s formulation | September 2033 | Active |
| 10,376,517 | A way of using it (U-3861) | September 2033 | Active |
| 11,564,926 | The active ingredient; the product’s formulation; a way of using it (U-3861) | September 2033 | Active |
| 11,986,481 | A way of using it (U-3861) | September 2033 | Active |
| 12,661,359 | A way of using it (U-4568) | January 2042 | Active |
| 12,377,104 | A way of using it (U-3861) | February 2045 | Active |
| 12,667,575 | A way of using it (U-4567) | February 2045 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| New chemical entity NCE | Five years of protection for a medicine whose active ingredient the FDA had never approved before. | March 2029 | Active |
Source: FDA Orange Book, application 217785. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Resmetirom
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
No company is recorded as having applied to the FDA to make a generic Rezdiffra yet.
Approved by the FDA
Not yet. The FDA has not approved a generic resmetirom. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic resmetirom for sale with the FDA.
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).
Rezdiffra Price: What Pharmacies Pay and What Generics Usually Do
What a Generic Could Cost
How we estimate it. The national survey of what pharmacies pay (NADAC) has no recent price for Rezdiffra, so we cannot show dollars. Here is the FDA’s finding of how far the price pharmacies pay 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).
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 Rezdiffra
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 Rezdiffra, before manufacturer rebates.
- $171.9M
- January to March 2026, the latest CMS has posted
For 16,896 people, about $4,347 per prescription fill - $475.8M
- 2025, the whole year
For 17,592 people, about $4,693 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $171,948,356 | 16,896 | $4,347.07 |
| 2025 | $475,817,436 | 17,592 | $4,693.31 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Rezdiffra only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain liver disease (nonalcoholic steatohepatitis-NASH). In people with NASH, fat builds up in the liver leading to inflammation and more serious liver problems over time.
Medicaid Prescriptions by Quarter
27,539 prescriptions in the four quarters to Q1 2026, $121M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 7,559 | $34,338,718 |
| Q4 2025 | 7,846 | $34,388,569 |
| Q3 2025 | 6,853 | $29,849,765 |
| Q2 2025 | 5,281 | $22,402,756 |
| Q1 2025 | 3,957 | $16,569,637 |
Source: CMS Medicaid State Drug Utilization Data, over Rezdiffra’s own package codes.
Rezdiffra Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 100MG | Tablet | Oral | March 2024 | Prescription reference product |
| 60MG | Tablet | Oral | March 2024 | Prescription reference product |
| 80MG | Tablet | Oral | March 2024 | Prescription reference product |
Source: FDA Orange Book, Madrigal Pharmaceuticals Inc. Listed for sale today by Madrigal Pharmaceuticals, Inc. (FDA NDC Directory).
Rezdiffra NDC Codes and Packages
Each Rezdiffra 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 |
|---|---|---|---|
| 82576-0100-30 | RESMETIROM 100 mg/1 tablet, coated | bottle of 30 tablets | Madrigal Pharmaceuticals, Inc. |
| 82576-0100-90 | RESMETIROM 100 mg/1 tablet, coated | bottle of 90 tablets | Madrigal Pharmaceuticals, Inc. |
| 82576-0060-30 | RESMETIROM 60 mg/1 tablet, coated | bottle of 30 tablets | Madrigal Pharmaceuticals, Inc. |
| 82576-0080-30 | RESMETIROM 80 mg/1 tablet, coated | bottle of 30 tablets | Madrigal Pharmaceuticals, Inc. |
| 82576-0080-90 | RESMETIROM 80 mg/1 tablet, coated | bottle of 90 tablets | Madrigal Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Rezdiffra’s own FDA approval (NDA 217785) are listed, never a generic. Some codes belong to companies that repackage Rezdiffra: it is the same medicine in a different package.
What a Generic Rezdiffra Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Rezdiffra 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 Rezdiffra”. 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 Rezdiffra
Is there a generic for Rezdiffra right now?
No. As of October 9, 2026 no generic resmetirom is listed for sale in the FDA NDC Directory.
When will Rezdiffra go generic?
2042 to 2043 is the expected window, and that is probable but not certain. The patent fight is likely to end in an agreement that sets the launch. The terms are not public yet. The last listed patent runs to February 2045, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic resmetirom be the same as Rezdiffra?
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. No company is recorded as having applied to the FDA to make one yet, and a single company usually brings only a modest drop.
Has the FDA approved a generic Rezdiffra?
Not yet. The FDA Orange Book lists no approved generic version of Rezdiffra.
When does the Rezdiffra patent expire?
The FDA Orange Book lists 8 patents for Rezdiffra; the last runs to February 2045. 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 (2042 to 2043) weighs all of that.
Changes to This Projection
- First generic expected 2042 to 2043 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
- BeleodaqBelinostat2026 to 2027
- KybellaDeoxycholic Acid2027 to 2028
- EvotazAtazanavir Sulfate and CobicistatDuring 2029
- XermeloTelotristat EtiprateFebruary 2031
- OtrexupMethotrexateMay 2031
- SynjardyEmpagliflozin and Metformin2032 to 2033
About Rezdiffra
- Generic name resmetirom
- How it is taken By mouth
- Company Madrigal Pharmaceuticals Inc
- More drugs Brand-name drugs starting with R
- Have a question? A pharmacist answers, free. Ask about Rezdiffra
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, 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.