Recorlev Generic: When Will Generic Levoketoconazole 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
Recorlev Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2034 to 2035 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? March 2040 9 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 levoketoconazole is expected to be available between 2034 and 2035. None is for sale yet.
Why 2034 to 2035?
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 Recorlev’s last patent runs to March 2040, how can a generic come sooner?
The 4 patents that run past the expected month, to March 2040 (11,020,393, 11,278,547, 11,903,940 and 12,377,096), 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. Generic companies have been challenging Recorlev’s patents with the FDA since December 2025. 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. A company may already hold a “tentative” approval, which this record does not show.
Will the generic cost less?
Usually, and more so as more companies sell one. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. See the price pattern
What should I do now?
Keep taking Recorlev 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.
Recorlev 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
- Strong 5 companies have filed, 4 first in line
- Brand sales
- Sales not reported
- FDA approved 2021 December 2021 FDA Orange Book
- Patents listed 9 last runs to March 2040 A generic is expected sooner, between 2034 and 2035. See why FDA Orange Book
- Medicare Part D spent $79.6M in 2025, for 494 people CMS Part D Spending by Drug
- Medicaid prescriptions 316 in the last four reported quarters, $8.8M CMS Medicaid drug utilization, to Q4 2025
Recorlev’s Road to a Generic
Recorlev has had the market to itself since the FDA approved it in December 2021 (Strongbridge Dublin Ltd). Its FDA protection (orphan drug) runs to December 2028. Its 9 listed patents run to March 2040 (4 already expired). Generic companies have challenged its patents with the FDA since December 2025.
The first generic of Recorlev is expected between 2034 and 2035.
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 March 2040
The last listed patent runs to March 2040, 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.
Recorlev Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Recorlev’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 |
|---|---|---|---|
| 10,098,877 | A way of using it (U-3283) | January 2026 | Expired |
| 10,517,868 | A way of using it (U-3283) | January 2026 | Expired |
| 10,835,530 | A way of using it (U-3283) | January 2026 | Expired |
| 11,478,471 | A way of using it (U-3283) | January 2026 | Expired |
| 9,918,984 | A way of using it (U-3283) | May 2028 | Active |
| 11,020,393 | A way of using it (U-3282) | March 2040 | Active |
| 11,278,547 | A way of using it (U-3282) | March 2040 | Active |
| 11,903,940 | A way of using it (U-3821) | March 2040 | Active |
| 12,377,096 | A way of using it (U-4236) | March 2040 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| FDA exclusivity NCE* | A period of protection the FDA granted (code NCE*). | December 2026 | Active |
| Orphan drug ODE-385 | Seven years of protection for a use in a rare disease. | December 2028 | Active |
Source: FDA Orange Book, application 214133. Patent numbers open the patent on Google Patents.
Patent Challenges to Recorlev
The first patent challenge to Recorlev reached the FDA in December 2025, from 4 companies on that first day. The FDA has not approved a first challenger’s generic yet.
What Is a Patent Challenge?
A generic company that wants to sell its version before Recorlev’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, 150 mg | December 2025 | 4 companies | No decision yet | Not yet | Not yet | March 2040 |
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 Levoketoconazole
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
5 companies have applied to the FDA to make generic levoketoconazole.
The FDA keeps applications private until it approves them, so the companies are not named here. Names often come out in the brand company’s patent lawsuits or in the companies’ own announcements.
First in line. 4 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 Recorlev’s patents with the FDA since December 2025: see the patent challenges.
Approved by the FDA
Not yet. The FDA has not approved a generic levoketoconazole. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic levoketoconazole for sale with the FDA.
Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).
Recorlev 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 Recorlev, 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 Recorlev
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 Recorlev, before manufacturer rebates.
- $26.9M
- January to March 2026, the latest CMS has posted
For 430 people, about $28,757 per prescription fill - $79.6M
- 2025, the whole year
For 494 people, about $28,276 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $26,916,966 | 430 | $28,757.44 |
| 2025 | $79,625,809 | 494 | $28,276.21 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Recorlev only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat high levels of a certain hormone (cortisol) in people with Cushing's syndrome. Levoketoconazole works by decreasing the amount of cortisol made by the body.
Medicaid Prescriptions by Quarter
316 prescriptions in the four quarters to Q4 2025, $8.8M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q4 2025 | 96 | $2,864,549 |
| Q3 2025 | 94 | $2,585,876 |
| Q2 2025 | 61 | $1,517,659 |
| Q1 2025 | 65 | $1,828,363 |
Source: CMS Medicaid State Drug Utilization Data, over Recorlev’s own package codes.
Recorlev Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| 150MG | Tablet | Oral | December 2021 | Prescription reference product |
Source: FDA Orange Book, Strongbridge Dublin Ltd. Listed for sale today by Xeris Pharmaceuticals, Inc. (FDA NDC Directory).
Recorlev NDC Codes and Packages
Each Recorlev 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 |
|---|---|---|---|
| 72065-0003-01 | LEVOKETOCONAZOLE 150 mg/1 tablet | bottle of 50 tablets | Xeris Pharmaceuticals, Inc. |
| 72065-0003-01 | LEVOKETOCONAZOLE 150 mg/1 tablet | bottle of 50 tablets | Xeris Pharmaceuticals, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Recorlev’s own FDA approval (NDA 214133) are listed, never a generic. Some codes belong to companies that repackage Recorlev: it is the same medicine in a different package.
What a Generic Recorlev Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Recorlev 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 Recorlev”. 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 Recorlev
Is there a generic for Recorlev right now?
No. As of October 9, 2026 no generic levoketoconazole is listed for sale in the FDA NDC Directory.
When will Recorlev go generic?
2034 to 2035 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 March 2040, but it covers a way of using it, not the medicine itself, which a generic can often work around or challenge.
Will generic levoketoconazole be the same as Recorlev?
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. 5 companies have applied to the FDA to make it. In the FDA’s study of past launches, pharmacies paid about 73% less once four companies sold a generic. That is a pattern from past launches, not a prediction for this one.
Has the FDA approved a generic Recorlev?
Not yet. The FDA Orange Book lists no approved generic version of Recorlev.
When does the Recorlev patent expire?
The FDA Orange Book lists 9 patents for Recorlev; the last runs to March 2040. 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 (2034 to 2035) weighs all of that.
Has anyone challenged the Recorlev patents?
Yes. The first patent challenge to Recorlev reached the FDA in December 2025, from 4 companies on that first day. The FDA has not approved a first challenger’s generic 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.
Changes to This Projection
- First generic expected 2034 to 2035 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
- XaraCollBupivacaine HydrochlorideMay 2029
- KimyrsaOritavancin DiphosphateAugust 2029
- AzmiroTestosterone CypionateMarch 2039
- OrlynvahProbenecid and Sulopenem EtzadroxilApril 2039
- SunosiSolriamfetol HydrochlorideDuring 2040
- EraxisAnidulafunginTBD no date yet
About Recorlev
- Generic name levoketoconazole
- How it is taken By mouth
- Company Strongbridge Dublin Ltd
- Patent challenges Since December 2025 (FDA)
- More drugs Brand-name drugs starting with R
- Have a question? A pharmacist answers, free. Ask about Recorlev
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, FDA NDC Directory, FDA Paragraph IV Patent Certifications list, 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.