{"answer":{"query":"Ninlaro","resolved_as":"applications","packages":6,"applications":["NDA208462"],"identity":{"application_numbers":["NDA208462"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2015-11-20","latest":"2015-11-20","packages_with_a_start_date":6}},"generic_entry":[{"application":"NDA208462","date":"2029-11-20","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":"7442830","productNo":"001"},"latest_patent_expiry":"2029-11-20","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":21,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":0,"fact_id":"f64d454b5a4aed0c1b3300c3"}],"label_history":{"events_total":9,"non_cmc_events":9,"counts_by_class":{"LABELING":8,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA208462","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-07-01","documents":[{"type":"Letter","date":"2024-07-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208462Orig1s017ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-07-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208462s017lbl.pdf","untrusted":true}}],"fact_id":"f3f087d80558ea68fec338a4"},{"application":"NDA208462","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-03-01","documents":[{"type":"Label","date":"2024-03-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208462s016lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-03-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208462Orig1s016ltr.pdf","untrusted":true}}],"fact_id":"1417eb78fa40c3ae88453f48"},{"application":"NDA208462","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-04-28","documents":[{"type":"Label","date":"2022-04-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208462s012s013lbl.pdf","untrusted":true}}],"fact_id":"7bf4918d7a9ab412c6b6616a"},{"application":"NDA208462","submission_no":12,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-04-28","documents":[{"type":"Label","date":"2022-04-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208462s012s013lbl.pdf","untrusted":true}}],"fact_id":"6708441f6e159dea326c788a"},{"application":"NDA208462","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-03-10","documents":[{"type":"Letter","date":"2021-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208462Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208462s010lbl.pdf","untrusted":true}}],"fact_id":"b4efa3586c257ed3f532d1f5"}],"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; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"NDA208462","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"NINLARO","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 4MG BASE","untrusted":true}},{"application":"NDA208462","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"NINLARO","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 3MG BASE","untrusted":true}},{"application":"NDA208462","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"NINLARO","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 2.3MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Ixazomib Citrate","untrusted":true},"brand":{"text":"Ninlaro","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":378740491.28,"claims":35205,"beneficiaries":5526,"average_spending_per_claim_usd":10758.144902,"fact_id":"60d15f4d854d7d1b616b7a64"},{"year":2021,"gross_spending_usd":366333435.97,"claims":32167,"beneficiaries":4879,"average_spending_per_claim_usd":11388.486212,"fact_id":"955788ea688652fcd92b3f95"},{"year":2022,"gross_spending_usd":340652029.69,"claims":28258,"beneficiaries":3985,"average_spending_per_claim_usd":12055.065103,"fact_id":"718518dddb6b8594ca4dcb4b"},{"year":2023,"gross_spending_usd":311982549.45,"claims":23996,"beneficiaries":3384,"average_spending_per_claim_usd":13001.4398,"fact_id":"0d5e98f02216aeef31982c72"},{"year":2024,"gross_spending_usd":272703342.48,"claims":21413,"beneficiaries":2983,"average_spending_per_claim_usd":12735.410381,"fact_id":"ce9413727397c5a7bf2b4967"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; 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}}},"medicaid_state_utilization":{"year":2025,"states_with_data":1,"all_states_medicaid_reimbursed_usd":873355.08,"all_states_medicaid_paid_prescriptions":65,"top_states":[{"state":"NY","medicaid_paid_prescriptions":65,"medicaid_reimbursed_usd":873355.08,"total_reimbursed_usd":873355.08,"packages":1,"covers":"all_record_types","fact_id":"b35b016440ac42fdc74076c4"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":4,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). Reimbursement is before manufacturer rebates: not a net cost, not a patient price. Suppressed managed-care cells make a state figure fee-for-service only. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"125ea50e86b2a18ca76ad1b9","field":"ndc.listing","entity":"ndc:63020023001"},{"fact_id":"0c7f230ac79ae7738225f40f","field":"ndc.listing","entity":"ndc:63020023002"},{"fact_id":"ff3c78b82085402eb5de53ba","field":"ndc.listing","entity":"ndc:63020039001"},{"fact_id":"f64d454b5a4aed0c1b3300c3","field":"drug.generic_entry_earliest","entity":"application:NDA208462"},{"fact_id":"9053c4412a9ce13a01ee4b3e","field":"drug.patent","entity":"application:NDA208462"},{"fact_id":"f3f087d80558ea68fec338a4","field":"drug.label_event","entity":"application:NDA208462"},{"fact_id":"1417eb78fa40c3ae88453f48","field":"drug.label_event","entity":"application:NDA208462"},{"fact_id":"7bf4918d7a9ab412c6b6616a","field":"drug.label_event","entity":"application:NDA208462"},{"fact_id":"6708441f6e159dea326c788a","field":"drug.label_event","entity":"application:NDA208462"},{"fact_id":"b4efa3586c257ed3f532d1f5","field":"drug.label_event","entity":"application:NDA208462"},{"fact_id":"9224fa96d3d9ba980d1937c8","field":"drug.marketing_status","entity":"application:NDA208462"},{"fact_id":"745fa6cf959f8b5f3871a9ef","field":"drug.marketing_status","entity":"application:NDA208462"},{"fact_id":"03a7adc59c4adfdf8fa5c2e8","field":"drug.marketing_status","entity":"application:NDA208462"},{"fact_id":"60d15f4d854d7d1b616b7a64","field":"drug.partd_spending","entity":"drug:ixazomib-citrate|ninlaro"},{"fact_id":"955788ea688652fcd92b3f95","field":"drug.partd_spending","entity":"drug:ixazomib-citrate|ninlaro"},{"fact_id":"718518dddb6b8594ca4dcb4b","field":"drug.partd_spending","entity":"drug:ixazomib-citrate|ninlaro"},{"fact_id":"0d5e98f02216aeef31982c72","field":"drug.partd_spending","entity":"drug:ixazomib-citrate|ninlaro"},{"fact_id":"ce9413727397c5a7bf2b4967","field":"drug.partd_spending","entity":"drug:ixazomib-citrate|ninlaro"},{"fact_id":"b35b016440ac42fdc74076c4","field":"ndc.medicaid_state_utilization","entity":"ndc_state:63020039002:NY"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. 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":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is 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."}