Orserdu Generic: When Will Generic Elacestrant 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
Orserdu Generic at a Glance
Four quick answers from FDA records and our estimate.
- When is the first generic expected? 2035 to 2037 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? January 2038 7 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 elacestrant hydrochloride is expected to be available between 2035 and 2037. None is for sale yet.
Why 2035 to 2037?
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 Orserdu’s last patent runs to January 2038, how can a generic come sooner?
The 2 patents that run past the expected month, to January 2038 (10,385,008 and 10,745,343), cover the active ingredient, the product’s formulation and a way of using it. A generic can still come sooner if a court rules a patent invalid or not infringed, or if the companies settle on an earlier date. 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 Orserdu 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.
Orserdu 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
- $607M a yearBig seller
- FDA approved 2023 January 2023 FDA Orange Book
- Patents listed 7 last runs to January 2038 A generic is expected sooner, between 2035 and 2037. See why FDA Orange Book
- Medicare Part D spent $386.8M in 2025, for 3,542 people CMS Part D Spending by Drug
- Medicaid prescriptions 1,031 in the last four reported quarters, $24.6M CMS Medicaid drug utilization, to Q1 2026
Orserdu’s Road to a Generic
Orserdu has had the market to itself since the FDA approved it in January 2023 (Stemline Therapeutics Inc). Its FDA protection (new chemical entity) runs to January 2028. Its 7 listed patents run to January 2038 (1 already expired).
The first generic of Orserdu is expected between 2035 and 2037.
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 January 2038
The last listed patent runs to January 2038; a court ruling or a settlement can bring a generic sooner. 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.
Orserdu Patents and FDA Protections
Every patent and exclusivity the FDA Orange Book lists for Orserdu’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 |
|---|---|---|---|
| 7,612,114 | The active ingredient; the product’s formulation; a way of using it (U-3523) | August 2026 | Expired |
| 10,071,066 | A way of using it (U-3524) | October 2034 | Active |
| 11,779,552 | A way of using it (U-3524) | October 2034 | Active |
| 10,420,734 | A way of using it (U-3524) | October 2036 | Active |
| 11,819,480 | A way of using it (U-3523) | February 2037 | Active |
| 10,385,008 | The active ingredient; the product’s formulation | January 2038 | Active |
| 10,745,343 | A way of using it (U-3523) | January 2038 | 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. | January 2028 | Active |
Source: FDA Orange Book, application 217639. Patent numbers open the patent on Google Patents.
Who Is Lined Up to Make Generic Elacestrant 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
No company is recorded as having applied to the FDA to make a generic Orserdu yet.
Approved by the FDA
Not yet. The FDA has not approved a generic elacestrant 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 elacestrant hydrochloride 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).
Orserdu 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 Orserdu, 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 Orserdu
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 Orserdu, before manufacturer rebates.
- $113M
- January to March 2026, the latest CMS has posted
For 1,955 people, about $25,638 per prescription fill - $386.8M
- 2025, the whole year
For 3,542 people, about $24,165 per prescription fill
See the numbers
| Period | Spending | People | Per fill |
|---|---|---|---|
| January to March 2026 | $112,959,189 | 1,955 | $25,637.58 |
| 2025 | $386,759,745 | 3,542 | $24,164.93 |
Source: CMS Medicare Part D Spending by Drug, matched by the brand name Orserdu only, so no generic is counted in it. What CMS says it is used for: Elacestrant is used to treat certain types of breast cancer. Breast cancer cells need the hormone estrogen to grow.
Medicaid Prescriptions by Quarter
1,031 prescriptions in the four quarters to Q1 2026, $24.6M paid.
See the numbers
| Quarter | Prescriptions | Medicaid paid |
|---|---|---|
| Q1 2026 | 247 | $6,169,477 |
| Q4 2025 | 290 | $7,001,472 |
| Q3 2025 | 264 | $6,299,899 |
| Q2 2025 | 230 | $5,173,691 |
| Q1 2025 | 157 | $3,757,877 |
Source: CMS Medicaid State Drug Utilization Data, over Orserdu’s own package codes.
Orserdu Strengths and Forms
| Strength | Form | How it is taken | Approved | Status |
|---|---|---|---|---|
| EQ 345MG BASE | Tablet | Oral | January 2023 | Prescription reference product |
| EQ 86MG BASE | Tablet | Oral | January 2023 | Prescription reference product |
Source: FDA Orange Book, Stemline Therapeutics Inc. Listed for sale today by Stemline Therapeutics, Inc. (FDA NDC Directory).
Orserdu NDC Codes and Packages
Each Orserdu 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 |
|---|---|---|---|
| 72187-0102-03 | ELACESTRANT 345 mg/1 tablet, film coated | bottle of 30 tablets | Stemline Therapeutics, Inc. |
| 72187-0102-03 | ELACESTRANT 345 mg/1 tablet, film coated | bottle of 30 tablets | Stemline Therapeutics, Inc. |
| 72187-0101-03 | ELACESTRANT 86 mg/1 tablet, film coated | bottle of 30 tablets | Stemline Therapeutics, Inc. |
| 72187-0101-03 | ELACESTRANT 86 mg/1 tablet, film coated | bottle of 30 tablets | Stemline Therapeutics, Inc. |
Source: the FDA NDC Directory, current listings only. Only packages sold under Orserdu’s own FDA approval (NDA 217639) are listed, never a generic. Some codes belong to companies that repackage Orserdu: it is the same medicine in a different package.
What a Generic Orserdu Means for You
Nothing Changes Until It Is in Pharmacies
Until a generic is actually for sale, keep filling Orserdu 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 Orserdu”. 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 Orserdu
Is there a generic for Orserdu right now?
No. As of October 9, 2026 no generic elacestrant hydrochloride is listed for sale in the FDA NDC Directory.
When will Orserdu go generic?
2035 to 2037 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 January 2038; a court ruling or a settlement can bring a generic sooner.
Will generic elacestrant hydrochloride be the same as Orserdu?
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 Orserdu?
Not yet. The FDA Orange Book lists no approved generic version of Orserdu.
When does the Orserdu patent expire?
The FDA Orange Book lists 7 patents for Orserdu; the last runs to January 2038. 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 (2035 to 2037) weighs all of that.
Changes to This Projection
- First generic expected 2035 to 2037 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
- ZykadiaCeritinibFebruary 2032
- CtexliChenodiolFebruary 2032
- VafseoVadadustat2034 to 2035
- MycapssaOctreotide Acetate2037 to 2039
- IbtroziTaletrectinib AdipateJune 2038
- RetevmoSelpercatinibApril 2039
About Orserdu
- Generic name elacestrant hydrochloride
- How it is taken By mouth
- Company Stemline Therapeutics Inc
- More drugs Brand-name drugs starting with O
- Have a question? A pharmacist answers, free. Ask about Orserdu
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.