Details for New Drug Application (NDA): 218881
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NDA 218881 describes INLURIYO, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the INLURIYO profile page.
The generic ingredient in INLURIYO is imlunestrant tosylate. One supplier is listed for this compound. Additional details are available on the imlunestrant tosylate profile page.
The generic ingredient in INLURIYO is imlunestrant tosylate. One supplier is listed for this compound. Additional details are available on the imlunestrant tosylate profile page.
Summary for 218881
| Tradename: | INLURIYO |
| Applicant: | Eli Lilly And Co |
| Ingredient: | imlunestrant tosylate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218881
Generic Entry Date for 218881*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 218881
Suppliers and Packaging for NDA: 218881
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INLURIYO | imlunestrant tosylate | TABLET;ORAL | 218881 | NDA | Eli Lilly and Company | 0002-1717 | 0002-1717-28 | 28 TABLET, FILM COATED in 1 BOTTLE (0002-1717-28) |
| INLURIYO | imlunestrant tosylate | TABLET;ORAL | 218881 | NDA | Eli Lilly and Company | 0002-1717 | 0002-1717-56 | 56 TABLET, FILM COATED in 1 BOTTLE (0002-1717-56) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Sep 25, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 25, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 11, 2039 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | 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 | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jul 11, 2039 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | 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 | ||||||||
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