{"answer":{"query":"Zejula","resolved_as":"applications","packages":5,"applications":["NDA214876"],"identity":{"application_numbers":["NDA214876"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2023-06-27","latest":"2023-06-27","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA214876","date":"2039-01-25","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled)","driver":{"kind":"patent","ref":"11730725","productNo":"001"},"latest_patent_expiry":"2039-01-25","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":24,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":8,"exclusivities_listed":0,"fact_id":"97cc4cadabc1535c5ada6dd5"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"LABELING":3,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA214876","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-03-27","documents":[{"type":"Letter","date":"2026-03-31","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214876Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-31","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214876Orig1s006lbl.pdf","untrusted":true}}],"fact_id":"61b89109e71f0354705a703e"},{"application":"NDA214876","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-07-18","documents":[{"type":"Letter","date":"2025-07-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214876Orig1s005ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-07-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876Orig1s005lbl.pdf","untrusted":true}}],"fact_id":"4692f247d7b3384e30751b8e"},{"application":"NDA214876","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-18","documents":[{"type":"Label","date":"2025-06-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876s003s004lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-06-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214876Orig1s003,s004ltr.pdf","untrusted":true}}],"fact_id":"4c62d49c3896fde7865683aa"},{"application":"NDA214876","submission_no":3,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-06-18","documents":[{"type":"Label","date":"2025-06-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214876s003s004lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-06-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214876Orig1s003,s004ltr.pdf","untrusted":true}}],"fact_id":"141e14a2674612cf8ae9aa81"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"NOT_PROVIDED":3},"marketing_status_counts":{"Prescription":3},"meaning":"raw FDA codes; 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not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"orphan_designation":{"ingredients":[{"ingredient":{"text":"niraparib","untrusted":true},"designation_count":4,"approved_count":3,"recent":[{"designated":"2025-10-17","use":{"text":"treatment of malignant glioma","untrusted":true},"status":"Designated","sponsor":{"text":"GSK","untrusted":true},"approved":false},{"designated":"2010-04-30","use":{"text":"Treatment of ovarian cancer","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"GlaxoSmithKline, LLC.","untrusted":true},"approved":true},{"designated":"2010-04-30","use":{"text":"Treatment of ovarian cancer","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"GlaxoSmithKline, LLC.","untrusted":true},"approved":true},{"designated":"2010-04-30","use":{"text":"Treatment of ovarian cancer","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"GlaxoSmithKline, LLC.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"bef00700aa022f4febfb323e"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; 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See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"NO_DATA","field":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}