Details for New Drug Application (NDA): 213702
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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
Generic Entry Date for 213702*:
Constraining patent/regulatory exclusivity:
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: | Jun 15, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | 7,763,615 | 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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