{"answer":{"query":"Ultomiris","resolved_as":"applications","packages":2,"applications":["BLA761108"],"identity":{"application_numbers":["BLA761108"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION, CONCENTRATE","untrusted":true}],"marketing_start":{"earliest":"2020-10-09","latest":"2020-10-09","packages_with_a_start_date":2}},"label_history":{"events_total":19,"non_cmc_events":18,"counts_by_class":{"EFFICACY":7,"REMS":6,"LABELING":5},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA761108","submission_no":46,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-10-21","documents":[{"type":"Letter","date":"2026-10-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125166Orig1s455, 761108Orig1s046ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-10-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761108s046lbl.pdf","untrusted":true}}],"fact_id":"9bac7d474d7398b23f646b31"},{"application":"BLA761108","submission_no":45,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2026-06-01","documents":[{"type":"Letter","date":"2026-06-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125166Orig1s453; 761108Orig1s045ltr.pdf","untrusted":true}}],"fact_id":"08537633984fe114ad2f82d0"},{"application":"BLA761108","submission_no":40,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2025-06-27","documents":[{"type":"Letter","date":"2025-06-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761108Orig1s040;125166Orig1s450ltr.pdf","untrusted":true}}],"fact_id":"f69d3e6a5390c3e8ff55e8de"},{"application":"BLA761108","submission_no":38,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2025-02-28","documents":[{"type":"Letter","date":"2025-03-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125166Orig1s448, 761108Orig1s038ltr.pdf","untrusted":true}}],"fact_id":"5beea32e6c7633475f46cab9"},{"application":"BLA761108","submission_no":37,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-09-19","documents":[{"type":"Label","date":"2024-09-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761108s037lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-09-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761108Orig1s037ltr.pdf","untrusted":true}}],"fact_id":"146756db8927bc770b9f3fba"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":1},"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":"BLA761108","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ULTOMIRIS","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"300MG/30ML(10MG/ML)","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Ravulizumab-Cwvz","untrusted":true},"brand":{"text":"Ultomiris","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":10577128.51,"claims":161,"beneficiaries":36,"average_spending_per_claim_usd":65696.450373,"fact_id":"af3f3b40037efa5c36673531"},{"year":2021,"gross_spending_usd":15592735.96,"claims":216,"beneficiaries":45,"average_spending_per_claim_usd":72188.592407,"fact_id":"64ef012009ce341a22ef75d6"},{"year":2022,"gross_spending_usd":46988002.58,"claims":701,"beneficiaries":195,"average_spending_per_claim_usd":67029.960884,"fact_id":"b5889e9b58868917cd2dd044"},{"year":2023,"gross_spending_usd":159533069.94,"claims":2503,"beneficiaries":493,"average_spending_per_claim_usd":63736.743883,"fact_id":"0f1181ac7a989c2d779b513b"},{"year":2024,"gross_spending_usd":232936290.52,"claims":3951,"beneficiaries":701,"average_spending_per_claim_usd":58956.287148,"fact_id":"7b8d9e44f85a3d50282ee1cc"}],"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}}},"biologic_status":{"products":[{"application":"BLA761108","status":"Reference","name":{"text":"Ultomiris","untrusted":true},"proper_name":{"text":"ravulizumab-cwvz","untrusted":true},"license_status":"Licensed","approval_date":"2018-12-21","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":0,"biosimilars":[],"interchangeables":[],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"fa85abfef4fbe7da94243d6d"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"payment_limit":{"codes":[{"hcpcs":"J1303","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":226.454,"dosage_descriptor":{"text":"10 MG","untrusted":true},"packages_matched":2,"read_on":"2026-11-07T07:31:28.000Z","source_url":{"text":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","untrusted":true},"fact_id":"96b9a16e41dd14ca63a64c7e"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; not a price a patient pays, and the presence of a code does not indicate that Medicare covers a product"},"rems":{"programs":[{"application":"BLA761108","program":{"text":"Ultomiris and Soliris","untrusted":true},"rems_id":"429","in_force":true,"released":false,"moved_to_shared_system":false,"has_etasu":true,"program_date":"2010-06-04","last_modified":"2026-10-21","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=429","other_programs":1,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"74db8cec2dddada80faa2b76"}],"reading":"what the FDA REMS@FDA files tie to the application on the read date; it does not say which prescribers or pharmacies take part or whether a patient needs the program"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"Ravulizumab; ravulizumab","untrusted":true},"designation_count":2,"approved_count":0,"recent":[{"designated":"2025-03-18","use":{"text":"Prevention of delayed graft function after renal transplantation","untrusted":true},"status":"Designated","sponsor":{"text":"Alexion Pharmaceuticals, Inc.","untrusted":true},"approved":false},{"designated":"2020-11-25","use":{"text":"Treatment of Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA)","untrusted":true},"status":"Designated","sponsor":{"text":"Alexion Pharmaceuticals, Inc.","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"e420281daffc0888bccf15f2"}],"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":2,"all_states_medicaid_reimbursed_usd":6747836.61,"all_states_medicaid_paid_prescriptions":163,"top_states":[{"state":"OH","medicaid_paid_prescriptions":94,"medicaid_reimbursed_usd":4044782.52,"total_reimbursed_usd":4181944.17,"packages":1,"covers":"fee_for_service_only","fact_id":"d76ad2c017e8017983c464c3"},{"state":"FL","medicaid_paid_prescriptions":69,"medicaid_reimbursed_usd":2703054.09,"total_reimbursed_usd":3012469.52,"packages":1,"covers":"fee_for_service_only","fact_id":"58844562aae3b82c7a0670fd"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":2,"older_year_facts_not_used":9,"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":"60addc345815f4e4ab576d80","field":"ndc.listing","entity":"ndc:25682002501"},{"fact_id":"e49e0974762fa39b3e2f16ab","field":"ndc.listing","entity":"ndc:25682002801"},{"fact_id":"9bac7d474d7398b23f646b31","field":"drug.label_event","entity":"application:BLA761108"},{"fact_id":"08537633984fe114ad2f82d0","field":"drug.label_event","entity":"application:BLA761108"},{"fact_id":"f69d3e6a5390c3e8ff55e8de","field":"drug.label_event","entity":"application:BLA761108"},{"fact_id":"5beea32e6c7633475f46cab9","field":"drug.label_event","entity":"application:BLA761108"},{"fact_id":"146756db8927bc770b9f3fba","field":"drug.label_event","entity":"application:BLA761108"},{"fact_id":"4d9330b4843e23d40b5b9d30","field":"drug.marketing_status","entity":"application:BLA761108"},{"fact_id":"af3f3b40037efa5c36673531","field":"drug.partd_spending","entity":"drug:ravulizumab-cwvz|ultomiris"},{"fact_id":"64ef012009ce341a22ef75d6","field":"drug.partd_spending","entity":"drug:ravulizumab-cwvz|ultomiris"},{"fact_id":"b5889e9b58868917cd2dd044","field":"drug.partd_spending","entity":"drug:ravulizumab-cwvz|ultomiris"},{"fact_id":"0f1181ac7a989c2d779b513b","field":"drug.partd_spending","entity":"drug:ravulizumab-cwvz|ultomiris"},{"fact_id":"7b8d9e44f85a3d50282ee1cc","field":"drug.partd_spending","entity":"drug:ravulizumab-cwvz|ultomiris"},{"fact_id":"fa85abfef4fbe7da94243d6d","field":"drug.biologic_status","entity":"application:BLA761108"},{"fact_id":"96b9a16e41dd14ca63a64c7e","field":"drug.asp_price","entity":"hcpcs:J1303"},{"fact_id":"74db8cec2dddada80faa2b76","field":"drug.rems","entity":"application:BLA761108"},{"fact_id":"e420281daffc0888bccf15f2","field":"drug.orphan_designation","entity":"drug:ravulizumab"},{"fact_id":"d76ad2c017e8017983c464c3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:25682002801:OH"},{"fact_id":"58844562aae3b82c7a0670fd","field":"ndc.medicaid_state_utilization","entity":"ndc_state:25682002501:FL"}],"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":"generic_entry:BLA761108","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"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":"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."}