FDA Orange Book
Is there a generic for Inluriyo?
Inluriyo contains imlunestrant. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Inluriyo (imlunestrant). The Orange Book shows its last listed patent expires July 11, 2039 and its last listed exclusivity ends September 25, 2030.
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Inluriyo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 200MG BASE | Marketed (Rx) | None | 0 | None |
NDA 218881, held by ELI LILLY AND CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Inluriyo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11117902 | July 11, 2039 | Drug substance, Drug product | U-4278 | 218881 |
| 10654866 | July 11, 2039 | Drug substance, Drug product | U-4278 | 218881 |
Inluriyo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 25, 2030 | 218881 |
Inluriyo NDC codes
Questions
Is there a generic for Inluriyo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Inluriyo (imlunestrant). The Orange Book shows its last listed patent expires July 11, 2039 and its last listed exclusivity ends September 25, 2030.
What is the generic name for Inluriyo?
The active ingredient in Inluriyo is imlunestrant, per the FDA Orange Book.
When does the Inluriyo patent expire?
The last patent listed for Inluriyo in the Orange Book expires July 11, 2039. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.