Details for New Drug Application (NDA): 218171
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NDA 218171 describes ENSACOVE, which is a drug marketed by Xcovery and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ENSACOVE profile page.
The generic ingredient in ENSACOVE is ensartinib hydrochloride. One supplier is listed for this compound. Additional details are available on the ensartinib hydrochloride profile page.
The generic ingredient in ENSACOVE is ensartinib hydrochloride. One supplier is listed for this compound. Additional details are available on the ensartinib hydrochloride profile page.
Summary for 218171
| Tradename: | ENSACOVE |
| Applicant: | Xcovery |
| Ingredient: | ensartinib hydrochloride |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218171
Generic Entry Date for 218171*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
CAPSULE;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.
Suppliers and Packaging for NDA: 218171
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENSACOVE | ensartinib hydrochloride | CAPSULE;ORAL | 218171 | NDA | Xcovery Holdings, Inc. | 83076-1025 | 83076-1025-3 | 30 CAPSULE in 1 BOTTLE (83076-1025-3) |
| ENSACOVE | ensartinib hydrochloride | CAPSULE;ORAL | 218171 | NDA | Xcovery Holdings, Inc. | 83076-1100 | 83076-1100-6 | 60 CAPSULE in 1 BOTTLE (83076-1100-6) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Dec 18, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 18, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,899,744 | Patent Expiration: | Jun 1, 2037 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHO HAVE NOT PREVIOUSLY RECEIVED AN ALK-INHIBITOR | ||||||||
| Patent: | 8,551,995 | Patent Expiration: | Feb 9, 2029 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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