Details for New Drug Application (NDA): 208447
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NDA 208447 describes ZEJULA, which is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ZEJULA profile page.
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.
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.
Pharmacology for NDA: 208447
| Mechanism of Action | Poly(ADP-Ribose) Polymerase Inhibitors |
Suppliers and Packaging for NDA: 208447
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447 | NDA | GlaxoSmithKline LLC | 69656-103 | 69656-103-30 | 30 CAPSULE in 1 BOTTLE (69656-103-30) |
| ZEJULA | niraparib tosylate | CAPSULE;ORAL | 208447 | NDA | GlaxoSmithKline LLC | 69656-103 | 69656-103-61 | 30 CAPSULE in 1 BOTTLE (69656-103-61) |
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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