{"answer":{"query":"Brukinsa","resolved_as":"applications","packages":2,"applications":["NDA213217","NDA218785"],"identity":{"application_numbers":["NDA213217","NDA218785"],"marketing_categories":["NDA"],"labelers":[{"text":"BeOne Medicines USA, Inc.","untrusted":true}],"dosage_forms":[{"text":"CAPSULE","untrusted":true},{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2019-11-14","latest":"2025-08-18","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA213217","date":"2043-01-19","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":"11786531","productNo":"001"},"latest_patent_expiry":"2043-01-19","latest_exclusivity_expiry":"2031-03-07","dated_barriers":19,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":12,"exclusivities_listed":7,"fact_id":"93105ceb43e8fee9197ec608"},{"application":"NDA218785","date":"2043-01-19","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":"11786531","productNo":"001"},"latest_patent_expiry":"2043-01-19","latest_exclusivity_expiry":"2031-03-07","dated_barriers":20,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":13,"exclusivities_listed":7,"fact_id":"fd64eba65dc882cfbcbc197e"}],"label_history":{"events_total":8,"non_cmc_events":8,"counts_by_class":{"LABELING":3,"EFFICACY":5},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA213217","submission_no":15,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-24","documents":[{"type":"Label","date":"2025-02-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213217s015lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213217Orig1s015ltr.pdf","untrusted":true}}],"fact_id":"f9c91a61771df9f8e5c29630"},{"application":"NDA213217","submission_no":14,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-06-04","documents":[{"type":"Letter","date":"2024-07-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213217Orig1s014ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-06-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217s014lbl.pdf","untrusted":true}}],"fact_id":"ae78776767192097ce1abe47"},{"application":"NDA213217","submission_no":11,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-03-07","documents":[{"type":"Label","date":"2024-03-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217s011lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-03-08","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213217Orig1s011ltr.pdf","untrusted":true}}],"fact_id":"91fd2a7e776846a73f6da980"},{"application":"NDA213217","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-12-21","documents":[{"type":"Label","date":"2023-12-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213217Orig1s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-12-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213217Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"21ff3df61aa008d020711f64"},{"application":"NDA213217","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-04-21","documents":[{"type":"Letter","date":"2023-04-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213217Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-04-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213217s010lbl.pdf","untrusted":true}}],"fact_id":"3d2df1adcf6844a7fce0f8ab"}],"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":{"Discontinued":1,"Prescription":2},"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":"NDA213217","product_no":"001","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"BRUKINSA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"80MG","untrusted":true}},{"application":"NDA218785","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"BRUKINSA","untrusted":true},"form":{"text":"CAPSULE; ORAL","untrusted":true},"strength":{"text":"80MG","untrusted":true}},{"application":"NDA218785","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"BRUKINSA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"160MG","untrusted":true}}]},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":1,"next_package_termination_dates":["2029-02-28"],"packages_with_future_termination_date":1,"termination_meaning":"manufacturer-reported last-lot expiry or withdrawal date of one package; other packages and generics can remain"},"spending":{"reported_under":{"generic":{"text":"Zanubrutinib","untrusted":true},"brand":{"text":"Brukinsa","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":12508806.89,"claims":990,"beneficiaries":249,"average_spending_per_claim_usd":12635.158475,"fact_id":"98169605fcbf2a595d896bd6"},{"year":2021,"gross_spending_usd":82575004.94,"claims":6477,"beneficiaries":1567,"average_spending_per_claim_usd":12748.958614,"fact_id":"3e9dd7c18061236d82f9d450"},{"year":2022,"gross_spending_usd":303322612.69,"claims":23517,"beneficiaries":3891,"average_spending_per_claim_usd":12898.014742,"fact_id":"1471b54bb5e816966bd31db5"},{"year":2023,"gross_spending_usd":801426530.79,"claims":59762,"beneficiaries":9470,"average_spending_per_claim_usd":13410.303049,"fact_id":"9b58c31cae0d25131adbf3c3"},{"year":2024,"gross_spending_usd":1724363413.8,"claims":130764,"beneficiaries":18031,"average_spending_per_claim_usd":13186.835932,"fact_id":"492daf96fc4ccdb42f18f804"}],"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}}},"orphan_designation":{"ingredients":[{"ingredient":{"text":"zanubrutinib","untrusted":true},"designation_count":8,"approved_count":7,"recent":[{"designated":"2024-05-20","use":{"text":"treatment of membranous nephropathy","untrusted":true},"status":"Designated","sponsor":{"text":"BeOne Medicines USA, Inc.","untrusted":true},"approved":false},{"designated":"2022-11-08","use":{"text":"Treatment of follicular lymphoma","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"BeOne Medicines USA, Inc.","untrusted":true},"approved":true},{"designated":"2020-08-24","use":{"text":"Treatment of extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT)","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"BeOne Medicines USA, Inc.","untrusted":true},"approved":true},{"designated":"2020-08-24","use":{"text":"Treatment of nodal marginal zone lymphoma (MZL)","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"BeOne Medicines USA, Inc.","untrusted":true},"approved":true},{"designated":"2020-08-24","use":{"text":"Treatment of splenic marginal zone lymphoma (MZL)","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"BeOne Medicines USA, Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"2d88922e82c9df002f61a2c9"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":1,"all_states_medicaid_reimbursed_usd":824967.72,"all_states_medicaid_paid_prescriptions":61,"top_states":[{"state":"MA","medicaid_paid_prescriptions":61,"medicaid_reimbursed_usd":824967.72,"total_reimbursed_usd":824967.72,"packages":1,"covers":"fee_for_service_only","fact_id":"7b3a1f60eca902a027fd0019"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":1,"older_year_facts_not_used":18,"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). 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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":"5470cab59275556147694b43","field":"ndc.listing","entity":"ndc:72579001102"},{"fact_id":"0ad21519e65bac28d6696045","field":"ndc.listing","entity":"ndc:72579012201"},{"fact_id":"93105ceb43e8fee9197ec608","field":"drug.generic_entry_earliest","entity":"application:NDA213217"},{"fact_id":"94691236bf8d9acc74981614","field":"drug.patent","entity":"application:NDA213217"},{"fact_id":"4b8ddfeb0e821a35916f88aa","field":"drug.exclusivity","entity":"application:NDA213217"},{"fact_id":"fd64eba65dc882cfbcbc197e","field":"drug.generic_entry_earliest","entity":"application:NDA218785"},{"fact_id":"5c73d966870acd248dffbd5f","field":"drug.patent","entity":"application:NDA218785"},{"fact_id":"8bb3118c45a732b917a5c332","field":"drug.exclusivity","entity":"application:NDA218785"},{"fact_id":"f9c91a61771df9f8e5c29630","field":"drug.label_event","entity":"application:NDA213217"},{"fact_id":"ae78776767192097ce1abe47","field":"drug.label_event","entity":"application:NDA213217"},{"fact_id":"91fd2a7e776846a73f6da980","field":"drug.label_event","entity":"application:NDA213217"},{"fact_id":"21ff3df61aa008d020711f64","field":"drug.label_event","entity":"application:NDA213217"},{"fact_id":"3d2df1adcf6844a7fce0f8ab","field":"drug.label_event","entity":"application:NDA213217"},{"fact_id":"a92510aae53899b3b7982d46","field":"drug.marketing_status","entity":"application:NDA213217"},{"fact_id":"ad39d04f089c683de4b74b45","field":"drug.marketing_status","entity":"application:NDA218785"},{"fact_id":"4b4e8b20317a41da4b25a02e","field":"drug.marketing_status","entity":"application:NDA218785"},{"fact_id":"c658d258cbf33504edc2645a","field":"ndc.product","entity":"ndc:72579001102"},{"fact_id":"98169605fcbf2a595d896bd6","field":"drug.partd_spending","entity":"drug:zanubrutinib|brukinsa"},{"fact_id":"3e9dd7c18061236d82f9d450","field":"drug.partd_spending","entity":"drug:zanubrutinib|brukinsa"},{"fact_id":"1471b54bb5e816966bd31db5","field":"drug.partd_spending","entity":"drug:zanubrutinib|brukinsa"},{"fact_id":"9b58c31cae0d25131adbf3c3","field":"drug.partd_spending","entity":"drug:zanubrutinib|brukinsa"},{"fact_id":"492daf96fc4ccdb42f18f804","field":"drug.partd_spending","entity":"drug:zanubrutinib|brukinsa"},{"fact_id":"2d88922e82c9df002f61a2c9","field":"drug.orphan_designation","entity":"drug:zanubrutinib"},{"fact_id":"7b3a1f60eca902a027fd0019","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72579001102:MA"}],"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":"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."}