Details for New Drug Application (NDA): 213702
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NDA 213702 describes ZEPZELCA, which is a drug marketed by Jazz 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 ZEPZELCA profile page.
The generic ingredient in ZEPZELCA is lurbinectedin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lurbinectedin profile page.
The generic ingredient in ZEPZELCA is lurbinectedin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the lurbinectedin profile page.
Summary for 213702
| Tradename: | ZEPZELCA |
| Applicant: | Jazz |
| Ingredient: | lurbinectedin |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213702
Generic Entry Date for 213702*:
Constraining patent/regulatory exclusivity:
LURBINECTEDIN IN COMBINATION WITH ATEZOLIZUMAB OR ATEZOLIZUMAB AND HYALURONIDASE-TQJS, FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FIRST-LINE INDUCTION THERAPY WITH ATEZOLIZUMAB OR ATEZOLIZUMAB AND HYALURONIDASE-TQJS, CARBOPLATIN, AND ETOPOSIDE Dosage:
POWDER;INTRAVENOUS |
*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: 213702
| Mechanism of Action | Alkylating Activity |
Suppliers and Packaging for NDA: 213702
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZEPZELCA | lurbinectedin | POWDER;INTRAVENOUS | 213702 | NDA | Jazz Pharmaceuticals, Inc. | 68727-712 | 68727-712-01 | 8 mL in 1 VIAL, SINGLE-DOSE (68727-712-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 4MG/VIAL | ||||
| Approval Date: | Jun 15, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 15, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 2, 2028 | ||||||||
| Regulatory Exclusivity Use: | LURBINECTEDIN IN COMBINATION WITH ATEZOLIZUMAB OR ATEZOLIZUMAB AND HYALURONIDASE-TQJS, FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FIRST-LINE INDUCTION THERAPY WITH ATEZOLIZUMAB OR ATEZOLIZUMAB AND HYALURONIDASE-TQJS, CARBOPLATIN, AND ETOPOSIDE | ||||||||
| Patent: | 12,324,806 | Patent Expiration: | May 29, 2040 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING METASTATIC SCLC AFTER PLATINUM CHEMOTHERAPY WITH LURBINECTEDIN MONOTHERAPY BY REDUCING THE DOSE FOR GRADE ≥3 HEPATOTOXICITY FROM 3.2 TO 2.6 MG/M2 AND 2.6 TO 2.0 MG/M2 LURBINECTEDIN WITHIN 35 DAYS OF THE HIGHER DOSE IF HEPATOTOXICITY ≤GRADE 1 | ||||||||
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