{"answer":{"query":"Winrevair","resolved_as":"applications","packages":4,"applications":["BLA761363"],"identity":{"application_numbers":["BLA761363"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2024-03-26","latest":"2024-03-26","packages_with_a_start_date":4}},"label_history":{"events_total":7,"non_cmc_events":7,"counts_by_class":{"LABELING":5,"EFFICACY":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761363","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-21","documents":[{"type":"Letter","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761363Orig1s012,s016,s017ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761363s012s016s017lbl.pdf","untrusted":true}}],"fact_id":"125731fabe526dbbd71639bc"},{"application":"BLA761363","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-21","documents":[{"type":"Letter","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761363Orig1s012,s016,s017ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761363s012s016s017lbl.pdf","untrusted":true}}],"fact_id":"81da9f7794e7b33f6b464902"},{"application":"BLA761363","submission_no":12,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-09-21","documents":[{"type":"Letter","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761363Orig1s012,s016,s017ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761363s012s016s017lbl.pdf","untrusted":true}}],"fact_id":"76f9fd7aa87369c8e5915b82"},{"application":"BLA761363","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-08-12","documents":[{"type":"Letter","date":"2026-08-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761363Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-08-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761363s013lbl.pdf","untrusted":true}}],"fact_id":"be259c2ada7f0cc65db331ce"},{"application":"BLA761363","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-03-25","documents":[{"type":"Label","date":"2026-03-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761363s010lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-03-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761363Orig1s010ltr.pdf","untrusted":true}}],"fact_id":"939bc4ae490517ff15236123"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"NOT_PROVIDED":2},"marketing_status_counts":{"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":"BLA761363","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"WINREVAIR","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"60MG","untrusted":true}},{"application":"BLA761363","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"WINREVAIR","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"45MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Sotatercept-Csrk","untrusted":true},"brand":{"text":"Winrevair","untrusted":true}},"latest_year":2024,"series":[{"year":2024,"gross_spending_usd":177621007.9,"claims":10663,"beneficiaries":1923,"average_spending_per_claim_usd":16657.695573,"fact_id":"255cfa60cbca30104fed04c7"}],"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":"BLA761363","status":"Reference","name":{"text":"Winrevair","untrusted":true},"proper_name":{"text":"sotatercept-csrk","untrusted":true},"license_status":"Licensed","approval_date":"2024-03-26","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":"b4b047f9bf16c61c3fb52974"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"sotatercept-csrk","untrusted":true},"designation_count":2,"approved_count":2,"recent":[{"designated":"2019-09-05","use":{"text":"Treatment of pulmonary arterial hypertension","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Merck Sharp & Dohme LLC","untrusted":true},"approved":true},{"designated":"2019-09-05","use":{"text":"Treatment of pulmonary arterial hypertension","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Merck Sharp & Dohme LLC","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"86a2357bd8126b61b8352f32"}],"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":21,"all_states_medicaid_reimbursed_usd":148802320.4,"all_states_medicaid_paid_prescriptions":8494,"top_states":[{"state":"CA","medicaid_paid_prescriptions":2838,"medicaid_reimbursed_usd":49200708.58,"total_reimbursed_usd":49399828.65,"packages":4,"covers":"all_record_types","fact_id":"df56a60de5f2c9ecfe2b47d4"},{"state":"NY","medicaid_paid_prescriptions":733,"medicaid_reimbursed_usd":12197230.77,"total_reimbursed_usd":12338435.13,"packages":3,"covers":"fee_for_service_only","fact_id":"1a307cbc66bed4a54c34b1d7"},{"state":"AZ","medicaid_paid_prescriptions":582,"medicaid_reimbursed_usd":11291840.1,"total_reimbursed_usd":11358788.79,"packages":3,"covers":"fee_for_service_only","fact_id":"ab9740729df67ca62c48a803"},{"state":"OR","medicaid_paid_prescriptions":532,"medicaid_reimbursed_usd":9992561.6,"total_reimbursed_usd":9993061.6,"packages":3,"covers":"fee_for_service_only","fact_id":"be5aaaad6fcba0083b0ea812"},{"state":"OH","medicaid_paid_prescriptions":556,"medicaid_reimbursed_usd":9723024.48,"total_reimbursed_usd":9970330.76,"packages":3,"covers":"fee_for_service_only","fact_id":"3f052483448bf0d36aa56896"},{"state":"PA","medicaid_paid_prescriptions":399,"medicaid_reimbursed_usd":6886326.46,"total_reimbursed_usd":7018878.34,"packages":3,"covers":"all_record_types","fact_id":"13c9f8358ba920e7998eb87c"},{"state":"IL","medicaid_paid_prescriptions":339,"medicaid_reimbursed_usd":6839617.29,"total_reimbursed_usd":6839617.29,"packages":3,"covers":"fee_for_service_only","fact_id":"cc21aa5fd91724ed20c31712"},{"state":"WA","medicaid_paid_prescriptions":350,"medicaid_reimbursed_usd":6827950.76,"total_reimbursed_usd":6827950.76,"packages":3,"covers":"fee_for_service_only","fact_id":"47b8a5f655366cc9da00085d"},{"state":"FL","medicaid_paid_prescriptions":331,"medicaid_reimbursed_usd":6011988.13,"total_reimbursed_usd":6026809.51,"packages":3,"covers":"fee_for_service_only","fact_id":"2e35421c1597275ae1911658"},{"state":"IN","medicaid_paid_prescriptions":279,"medicaid_reimbursed_usd":5668113.7,"total_reimbursed_usd":5668113.7,"packages":2,"covers":"fee_for_service_only","fact_id":"f84fa8142a2aae0d715c0144"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":12448,"medicaid_reimbursed_usd":229179899.37,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":48,"facts_fee_for_service_only":21,"older_year_facts_not_used":0,"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":"258d04e3235ee92562dcd55c","field":"ndc.listing","entity":"ndc:00006508701"},{"fact_id":"6e2fcd56e5deee40a962edd5","field":"ndc.listing","entity":"ndc:00006508801"},{"fact_id":"24377ce2ab33497777e1c944","field":"ndc.listing","entity":"ndc:00006509001"},{"fact_id":"125731fabe526dbbd71639bc","field":"drug.label_event","entity":"application:BLA761363"},{"fact_id":"81da9f7794e7b33f6b464902","field":"drug.label_event","entity":"application:BLA761363"},{"fact_id":"76f9fd7aa87369c8e5915b82","field":"drug.label_event","entity":"application:BLA761363"},{"fact_id":"be259c2ada7f0cc65db331ce","field":"drug.label_event","entity":"application:BLA761363"},{"fact_id":"939bc4ae490517ff15236123","field":"drug.label_event","entity":"application:BLA761363"},{"fact_id":"a4e38da5cdaa773e5553c2b8","field":"drug.marketing_status","entity":"application:BLA761363"},{"fact_id":"27e3360ec4dd1ce156cf3895","field":"drug.marketing_status","entity":"application:BLA761363"},{"fact_id":"255cfa60cbca30104fed04c7","field":"drug.partd_spending","entity":"drug:sotatercept-csrk|winrevair"},{"fact_id":"b4b047f9bf16c61c3fb52974","field":"drug.biologic_status","entity":"application:BLA761363"},{"fact_id":"86a2357bd8126b61b8352f32","field":"drug.orphan_designation","entity":"drug:sotatercept-csrk"},{"fact_id":"df56a60de5f2c9ecfe2b47d4","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006509001:CA"},{"fact_id":"1a307cbc66bed4a54c34b1d7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006509001:NY"},{"fact_id":"ab9740729df67ca62c48a803","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006508701:AZ"},{"fact_id":"be5aaaad6fcba0083b0ea812","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006508701:OR"},{"fact_id":"3f052483448bf0d36aa56896","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006509001:OH"},{"fact_id":"13c9f8358ba920e7998eb87c","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006509001:PA"},{"fact_id":"cc21aa5fd91724ed20c31712","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006508701:IL"},{"fact_id":"47b8a5f655366cc9da00085d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006508701:WA"},{"fact_id":"2e35421c1597275ae1911658","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006508701:FL"},{"fact_id":"f84fa8142a2aae0d715c0144","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006508701:IN"}],"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:BLA761363","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":"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."}