Prescription medicine
Elacestrant Brand names: Orserdu
Elacestrant (Orserdu) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the elacestrant FDA label on DailyMed (effective June 24, 2026, Stemline Therapeutics, Inc.); the NDA 217639 record on Drugs@FDA; every elacestrant label on DailyMed.
Highlights of the record
FDA label of June 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration ( 2.1 )], with disease progression following at least one line of endocrine therapy.
Forms and strengths
- 86 mg
- 345 mg
Film-coated tablet.
On the market
- Earliest approval on file
- January 27, 2023 Orserdu, Stemline Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 5, 2038 Orserdu tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,117 through July 30, 2026
What is elacestrant used for?
From the label: indications and usageORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration ( 2.1 )], with disease progression following at least one line of endocrine therapy. ORSERDU is an estrogen receptor antagonist indicated for: treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy
Conditions named in the indications of elacestrant's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Estrogen Receptor Antagonist.
Source: FDA drug label (ORSERDU), Stemline Therapeutics, Inc., effective June 24, 2026 (SPL set aa66ae5c-2bd2-4444-8178-b55651e054ef), via openFDA; the full label on DailyMed
Is there a generic for elacestrant (Orserdu)?
No generic elacestrant is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Orserdu tablets: the compound patent runs to January 5, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2038 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the elacestrant label say about other medicines?
The elacestrant label names no other medicine on this site. The labels of 1 other medicine name elacestrant. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name elacestrant
Source: FDA drug label (ORSERDU), Stemline Therapeutics, Inc., effective June 24, 2026 (SPL set aa66ae5c-2bd2-4444-8178-b55651e054ef), via openFDA; the full label on DailyMed
What do FAERS reports show for elacestrant?
The FDA Adverse Event Reporting System holds 7,117 reports that list elacestrant among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 548 are coded as a death and 891 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2024 (3,661, against a median of 0 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as elacestrant?
17 other medicines are given the same way (oral) and in the same FDA class as elacestrant or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Imlunestrant | Breast cancer | none listed | n/a | No current entry |
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 mg tablet | No current entry |
| Tamoxifen | Breast cancer | 10 labelers | $0.277 per tablet 20 mg tablet | No current entry |
| Exemestane | Breast cancer | 10 labelers | $0.748 per tablet 25 mg tablet | No current entry |
| Talazoparib | Breast cancer | none listed | n/a | No current entry |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as elacestrant
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to elacestrant
- 17 medicines for the same use
- Other estrogen receptor antagonists
- the pharmacologic class, with prices and generics
- Elacestrant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other