Details for New Drug Application (NDA): 219008
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NDA 219008 describes LAZCLUZE, which is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the LAZCLUZE profile page.
The generic ingredient in LAZCLUZE is lazertinib mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lazertinib mesylate profile page.
The generic ingredient in LAZCLUZE is lazertinib mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lazertinib mesylate profile page.
Summary for 219008
| Tradename: | LAZCLUZE |
| Applicant: | Janssen Biotech |
| Ingredient: | lazertinib mesylate |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219008
Generic Entry Date for 219008*:
Constraining patent/regulatory exclusivity:
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: 219008
Suppliers and Packaging for NDA: 219008
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LAZCLUZE | lazertinib mesylate | TABLET;ORAL | 219008 | NDA | Janssen Biotech, Inc. | 57894-080 | 57894-080-60 | 1 BOTTLE in 1 CARTON (57894-080-60) / 60 TABLET, FILM COATED in 1 BOTTLE |
| LAZCLUZE | lazertinib mesylate | TABLET;ORAL | 219008 | NDA | Janssen Biotech, Inc. | 57894-080 | 57894-080-90 | 1 BOTTLE in 1 CARTON (57894-080-90) / 90 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 80MG BASE | ||||
| Approval Date: | Aug 19, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 19, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,453,656 | Patent Expiration: | Apr 18, 2038 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 11,850,248 | Patent Expiration: | Aug 1, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FIRST-LINE TREATMENT OF ADULTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 L858R SUBSTITUTION MUTATIONS, IN COMBINATION WITH AMIVANTAMAB | ||||||||
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