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 is one patent protecting this drug. Additional details are available on the ZEPZELCA profile page.
The generic ingredient in ZEPZELCA is lurbinectedin. One supplier is listed for this compound. Additional details are available on the lurbinectedin profile page.
The generic ingredient in ZEPZELCA is lurbinectedin. 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: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213702
*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: | Jun 15, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 13, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF ADULT PATIENTS WITH SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY. | ||||||||
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