Details for New Drug Application (NDA): 208447
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The generic ingredient in ZEJULA is niraparib tosylate. One supplier is listed for this compound. Additional details are available on the niraparib tosylate profile page.
Summary for 208447
Tradename: | ZEJULA |
Applicant: | Glaxosmithkline |
Ingredient: | niraparib tosylate |
Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208447
Generic Entry Date for 208447*:
Constraining patent/regulatory exclusivity:
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.
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Mar 27, 2017 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Mar 27, 2024 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY | ||||||||
Regulatory Exclusivity Expiration: | Apr 29, 2027 | ||||||||
Regulatory Exclusivity Use: | INDICATED FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY | ||||||||
Regulatory Exclusivity Expiration: | Oct 23, 2026 | ||||||||
Regulatory Exclusivity Use: | TX OF ADULTS W/ ADV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER TREATED W/ >=3 PRIOR CHEMO REGIMENS & CANCER ASSOCIATED W/ HRD+ STATUS DEFINED BY A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION |
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