INLURIYO
NDA 218881 · New Drug Application (NDA) Prescription
IMLUNESTRANT TOSYLATE
- Sponsor (Drugs@FDA)
- ELI LILLY AND CO Company: ELI LILLY & Co (LLY)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | INLURIYO IMLUNESTRANT TOSYLATE | TABLET;ORAL EQ 200MG BASE | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 1 | Approved | standard | Efficacy | Letter for Supplement 1 (opens in a new tab)Label for Supplement 1 (opens in a new tab) | |
| Original 1 | Approved | standard | Type 1 - New Molecular Entity | Letter for Original 1 (opens in a new tab)Label for Original 1 (opens in a new tab) |
Orange Book patents
2 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 10654866Product 001 | Drug substance, Drug product | U-4278 | ||
| 11117902Product 001 | Drug substance, Drug product | U-4278 |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| NCE | 001 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
1 product in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0002-1717 in openFDA (opens in a new tab) | Inluriyo imlunestrant | Eli Lilly and Company | TABLET, FILM COATED ORAL | NDA | From |
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FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.