Isturisa Generic: When Will Generic Osilodrostat 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
Isturisa Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? October 2035 About 9 years away 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? October 2035 6 patents listed with the FDA
- Can you buy a generic today? Not yet No company lists one for sale
Generic osilodrostat phosphate is expected to be available in October 2035, about 9 years away. None is for sale yet.
Why October 2035?
It is when Isturisa’s patent 10,709,691 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them. We rate it toss-up: still unsettled. Just as likely to slip as to hold.
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 Isturisa 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.
Isturisa by the Numbers
- Reason
- Patent expiresA patent that protects the brand runs out. After that, approved generics can be sold.
- How sure
- Toss-up Still unsettled. Just as likely to slip as to hold.
- Price competition
- None filed yet No filers on record
- Brand sales
- Sales not reported
- FDA approved 2020 March 2020 FDA Orange Book
- Patents listed 6 last runs to October 2035 FDA Orange Book
- Medicare Part D spent $94.7M in 2025, for 597 people CMS Part D Spending by Drug
- Medicaid prescriptions 347 in the last four reported quarters, $9.2M CMS Medicaid drug utilization, to Q1 2026
Isturisa’s Road to a Generic
Isturisa has had the market to itself since the FDA approved it in March 2020 (Recordati Rare Diseases Inc). Its FDA protection (orphan drug) runs to April 2032. Its 6 listed patents run to October 2035 (1 already expired).
The first generic of Isturisa is expected in October 2035.
Why that month: patent 10,709,691, on a way of using it, ends then.
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.
Isturisa Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Isturisa’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.
The one that matters for a generic launch: patent 10,709,691, which ends in October 2035, the month the first generic is expected.
| Patent | What it covers | Protects until | Status |
|---|---|---|---|
| 8,835,646 | The active ingredient; the product’s formulation | August 2026 | Expired |
| 8,609,862 | A way of using it (U-2770, U-4529) | January 2031 | Active |
| 9,434,754 | The active ingredient | January 2031 | Active |
| 8,314,097 | The active ingredient; the product’s formulation | May 2033 | Active |
| 10,143,680 | The product’s formulation | July 2035 | Active |
| 10,709,691 Sets the expected month of generic availability | A way of using it (U-2770, U-4529) | October 2035 | Active |
| Exclusivity | What it means | Ends | Status |
|---|---|---|---|
| Orphan drug ODE-286 | Seven years of protection for a use in a rare disease. | March 2027 | Active |
| Orphan drug ODE-535 | Seven years of protection for a use in a rare disease. | April 2032 | Active |
Source: FDA Orange Book, application 212801. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Osilodrostat Phosphate
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 Isturisa yet.
Approved by the FDA
Not yet. The FDA has not approved a generic osilodrostat phosphate. Final approval often comes close to the day a generic can be sold.
For Sale in Pharmacies
Not yet. No company lists a generic osilodrostat phosphate 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).
Isturisa 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 Isturisa, 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 Isturisa
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 Isturisa, before manufacturer rebates.
- $36.5M
- January to March 2026, the latest CMS has posted
For 505 people, about $30,443 per prescription fill - $94.7M
- 2025, the whole year
For 597 people, about $24,224 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $36,531,247 | 505 | $30,442.71 |
| 2025 | $94,716,399 | 597 | $24,224.14 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Isturisa only, so no generic is counted in it. What CMS says it is used for: This medication is used to treat a certain hormone problem (Cushing's disease) caused by a tumor in a certain part of the brain (pituitary gland). People with Cushing's disease produce too much of a certain hormone (cortisol).
Medicaid Prescriptions by Quarter
347 prescriptions in the four quarters to Q1 2026, $9.2M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 73 | $3,506,305 |
| Q4 2025 | 64 | $1,268,637 |
| Q3 2025 | 114 | $2,523,145 |
| Q2 2025 | 96 | $1,939,682 |
| Q1 2025 | 82 | $1,752,341 |
Source: CMS Medicaid State Drug Utilization Data, over Isturisa’s own package codes.
Isturisa Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 1MG BASE | Tablet | Oral | March 2020 | Prescription reference product |
| EQ 5MG BASE | Tablet | Oral | March 2020 | Prescription reference product |
| EQ 10MG BASE | Tablet | Oral | March 2020 | Discontinued reference product |
Source: FDA Orange Book, Recordati Rare Diseases Inc. Listed for sale today by Recordati Rare Diseases, Inc. (FDA NDC Directory).
Isturisa NDC Codes and Packages
Each Isturisa 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 |
|---|---|---|---|
| 55292-0322-20 | 10 mg tablet, coated | blister pack of 20 tablets | Recordati Rare Diseases, Inc. |
| 55292-0322-60 | 10 mg tablet, coated | blister pack of 60 tablets | Recordati Rare Diseases, Inc. |
| 55292-0320-20 | OSILODROSTAT PHOSPHATE 1 mg/1 tablet, coated | blister pack of 20 tablets | Recordati Rare Diseases, Inc. |
| 55292-0320-20 | OSILODROSTAT PHOSPHATE 1 mg/1 tablet, coated | blister pack of 20 tablets | Recordati Rare Diseases, Inc. |
| 55292-0320-60 | OSILODROSTAT PHOSPHATE 1 mg/1 tablet, coated | blister pack of 60 tablets | Recordati Rare Diseases, Inc. |
| 55292-0320-60 | OSILODROSTAT PHOSPHATE 1 mg/1 tablet, coated | blister pack of 60 tablets | Recordati Rare Diseases, Inc. |
| 55292-0330-20 | OSILODROSTAT PHOSPHATE 1 mg/1 tablet, coated | blister pack of 20 tablets | Recordati Rare Diseases, Inc. |
| 55292-0330-60 | OSILODROSTAT PHOSPHATE 1 mg/1 tablet, coated | blister pack of 60 tablets | Recordati Rare Diseases, Inc. |
Show the other 6 Isturisa packages
| NDC | Product | Package | Company |
|---|---|---|---|
| 55292-0321-20 | OSILODROSTAT PHOSPHATE 5 mg/1 tablet, coated | blister pack of 20 tablets | Recordati Rare Diseases, Inc. |
| 55292-0321-20 | OSILODROSTAT PHOSPHATE 5 mg/1 tablet, coated | blister pack of 20 tablets | Recordati Rare Diseases, Inc. |
| 55292-0321-60 | OSILODROSTAT PHOSPHATE 5 mg/1 tablet, coated | blister pack of 60 tablets | Recordati Rare Diseases, Inc. |
| 55292-0321-60 | OSILODROSTAT PHOSPHATE 5 mg/1 tablet, coated | blister pack of 60 tablets | Recordati Rare Diseases, Inc. |
| 55292-0331-20 | OSILODROSTAT PHOSPHATE 5 mg/1 tablet, coated | blister pack of 20 tablets | Recordati Rare Diseases, Inc. |
| 55292-0331-60 | OSILODROSTAT PHOSPHATE 5 mg/1 tablet, coated | blister pack of 60 tablets | Recordati Rare Diseases, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Isturisa’s own FDA approval (NDA 212801) are listed, never a generic. Some codes belong to companies that repackage Isturisa: it is the same medicine in a different package.
What a Generic Isturisa Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Isturisa 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 Isturisa”. 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 Isturisa
Is there a generic for Isturisa right now?
No. As of October 9, 2026 no generic osilodrostat phosphate is listed for sale in the FDA NDC Directory.
When will Isturisa go generic?
October 2035 is the expected month, and that is toss-up but not certain. It is when Isturisa’s patent 10,709,691 ends. That patent covers a way of using it, and once it ends, generics can go on sale as soon as the FDA approves them.
Will generic osilodrostat phosphate be the same as Isturisa?
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 Isturisa?
Not yet. The FDA Orange Book lists no approved generic version of Isturisa.
When does the Isturisa patent expire?
The FDA Orange Book lists 6 patents for Isturisa; the last runs to October 2035. The one behind the expected month is patent 10,709,691, which ends in October 2035. 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 month on this page (October 2035) weighs all of that.
Changes to This Projection
- First generic expected October 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
- ZelborafVemurafenibJune 2029
- TriesenceTriamcinolone AcetonideDecember 2029
- PylarifyPiflufolastat F 18June 2034
- Furoscix ReadyFlowFurosemideJanuary 2040
- LumakrasSotorasibAugust 2040
- CabenuvaCabotegravir and RilpivirineOctober 2040
About Isturisa
- Generic name osilodrostat phosphate
- How it is taken By mouth
- Company Recordati Rare Diseases Inc
- More drugs Brand-name drugs starting with I
- Have a question? A pharmacist answers, free. Ask about Isturisa
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.