Prescription medicine
Imlunestrant Brand names: Inluriyo
Imlunestrant (Inluriyo) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the imlunestrant FDA label on DailyMed (effective June 4, 2026, Eli Lilly and Company); the NDA 218881 record on Drugs@FDA; every imlunestrant label on DailyMed.
Highlights of the record
FDA label of June 4, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageINLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Forms and strengths
- 200 mg
Film-coated tablet.
On the market
- Earliest approval on file
- September 25, 2025 Inluriyo, Eli Lilly And Co; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- July 11, 2039 Inluriyo 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
What is imlunestrant used for?
From the label: indications and usageINLURIYO is indicated for the treatment of adults with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor-1 ( ESR1 )-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. INLURIYO TM is an estrogen receptor antagonist indicated for: treatment of adults with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy
Conditions named in the indications of imlunestrant's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Estrogen Receptor Antagonist.
Source: FDA drug label (Inluriyo), Eli Lilly and Company, effective June 4, 2026 (SPL set 5bc172e4-e8a2-441a-be52-279a7f890196), via openFDA; the full label on DailyMed
Is there a generic for imlunestrant (Inluriyo)?
No generic imlunestrant is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Inluriyo tablets: the compound patent runs to July 11, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2025 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What else is labeled for the same conditions as imlunestrant?
17 other medicines are given the same way (oral) and in the same FDA class as imlunestrant 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 |
|---|---|---|---|---|
| Elacestrant | 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 imlunestrant
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to imlunestrant
- 17 medicines for the same use
- Other estrogen receptor antagonists
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other