{"answer":{"query":"Evenity","resolved_as":"applications","packages":3,"applications":["BLA761062"],"identity":{"application_numbers":["BLA761062"],"marketing_categories":["BLA"],"labelers":[{"text":"AMGEN INC.","untrusted":true}],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2019-04-09","latest":"2026-01-01","packages_with_a_start_date":3}},"label_history":{"events_total":1,"non_cmc_events":1,"counts_by_class":{"LABELING":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761062","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-12-20","documents":[{"type":"Label","date":"2019-12-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761062s002lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-12-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761062Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"8665257f5c881c52153e6c62"}],"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":"BLA761062","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"EVENITY","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"105MG/1.17ML","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":3,"most_recent":[{"recall_number":"D-0539-2025","classification":"Class II","status":"Ongoing","report_date":"2025-07-30","recall_initiated":"2025-04-21","recalling_firm":{"text":"Mckesson Medical-Surgical Inc. Corporate Office","untrusted":true},"reason":{"text":"CGMP Deviations; potential temperature excursions due to transit delays","untrusted":true},"packages_named":3,"fact_id":"e0872fd0513e39d2abfefe56"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":1,"next_package_termination_dates":["2027-12-31"],"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":"Romosozumab-Aqqg","untrusted":true},"brand":{"text":"Evenity","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":73486.9,"claims":39,"beneficiaries":21,"average_spending_per_claim_usd":1884.2794872,"fact_id":"3c664fd7a5655318e83d0873"},{"year":2021,"gross_spending_usd":99693.99,"claims":51,"beneficiaries":23,"average_spending_per_claim_usd":1954.7841176,"fact_id":"93a1c7e26a35d04e0fb52ca5"},{"year":2022,"gross_spending_usd":363407.14,"claims":172,"beneficiaries":68,"average_spending_per_claim_usd":2112.8322093,"fact_id":"56677d64511b496415f4b6f0"},{"year":2023,"gross_spending_usd":1024894.36,"claims":440,"beneficiaries":145,"average_spending_per_claim_usd":2329.3053636,"fact_id":"31079d76292d6a9b8618990e"},{"year":2024,"gross_spending_usd":1427075.38,"claims":595,"beneficiaries":200,"average_spending_per_claim_usd":2398.4460168,"fact_id":"938ff82569e6d8707d22ba73"}],"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":"BLA761062","status":"Reference","name":{"text":"Evenity","untrusted":true},"proper_name":{"text":"romosozumab-aqqg","untrusted":true},"license_status":"Licensed","approval_date":"2019-04-09","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":"01975a02cd9faca93b3a168a"}],"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":"J3111","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":12.792,"dosage_descriptor":{"text":"1 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":"ac04c26244fb5463ac2b1308"}],"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"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"romosozumab","untrusted":true},"designation_count":1,"approved_count":0,"recent":[{"designated":"2021-05-10","use":{"text":"Treatment of Osteogenesis Imperfecta","untrusted":true},"status":"Designated","sponsor":{"text":"Amgen Inc.","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"5aa8bb4d47fa1c30bc0d1394"}],"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":36,"all_states_medicaid_reimbursed_usd":20513703.15,"all_states_medicaid_paid_prescriptions":12588,"top_states":[{"state":"CA","medicaid_paid_prescriptions":2574,"medicaid_reimbursed_usd":5591594.86,"total_reimbursed_usd":5719065.72,"packages":1,"covers":"all_record_types","fact_id":"de51a18a66eb374e7b97e2de"},{"state":"SD","medicaid_paid_prescriptions":351,"medicaid_reimbursed_usd":2095640.71,"total_reimbursed_usd":2095640.71,"packages":1,"covers":"all_record_types","fact_id":"4fff899b4b6bb5fc7eedceb2"},{"state":"NY","medicaid_paid_prescriptions":1100,"medicaid_reimbursed_usd":1730124.72,"total_reimbursed_usd":2042574.1,"packages":1,"covers":"all_record_types","fact_id":"57c98622ec50875ffd903ef9"},{"state":"AZ","medicaid_paid_prescriptions":1117,"medicaid_reimbursed_usd":1255705.4,"total_reimbursed_usd":1255705.4,"packages":1,"covers":"fee_for_service_only","fact_id":"360476cc0bafd12d39a41200"},{"state":"NJ","medicaid_paid_prescriptions":552,"medicaid_reimbursed_usd":1146929.87,"total_reimbursed_usd":1448131.01,"packages":2,"covers":"all_record_types","fact_id":"50c710681832f1fd2c046a78"},{"state":"MN","medicaid_paid_prescriptions":478,"medicaid_reimbursed_usd":1124732.44,"total_reimbursed_usd":1137611.2,"packages":1,"covers":"fee_for_service_only","fact_id":"35fd1c454a6b6c208e79a817"},{"state":"IL","medicaid_paid_prescriptions":825,"medicaid_reimbursed_usd":1074203.43,"total_reimbursed_usd":1736638,"packages":1,"covers":"all_record_types","fact_id":"92d1ce4ce6859d9e79b7712a"},{"state":"PA","medicaid_paid_prescriptions":479,"medicaid_reimbursed_usd":609297.59,"total_reimbursed_usd":1136861.68,"packages":1,"covers":"all_record_types","fact_id":"03b233de894455b5a3fb7907"},{"state":"IN","medicaid_paid_prescriptions":571,"medicaid_reimbursed_usd":576699.87,"total_reimbursed_usd":980535.55,"packages":1,"covers":"all_record_types","fact_id":"6e347580c8c22144df1e54cc"},{"state":"CO","medicaid_paid_prescriptions":418,"medicaid_reimbursed_usd":468855.27,"total_reimbursed_usd":469275.18,"packages":1,"covers":"fee_for_service_only","fact_id":"d3d889db4f1f02a663b3e9ce"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":13538,"medicaid_reimbursed_usd":21912982.75,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":38,"facts_fee_for_service_only":22,"older_year_facts_not_used":28,"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":"f8e5f73c96e723bf7fa3a755","field":"ndc.listing","entity":"ndc:55513050902"},{"fact_id":"688fdee77f76bc41ae587289","field":"ndc.listing","entity":"ndc:55513088002"},{"fact_id":"974194f805912cacebbe019e","field":"ndc.listing","entity":"ndc:55513099802"},{"fact_id":"8665257f5c881c52153e6c62","field":"drug.label_event","entity":"application:BLA761062"},{"fact_id":"c5a5c24ae4e9db47110e7e9a","field":"drug.marketing_status","entity":"application:BLA761062"},{"fact_id":"e0872fd0513e39d2abfefe56","field":"ndc.recall","entity":"ndc:55513088002"},{"fact_id":"ef8732054cfd6f69e713fa69","field":"ndc.product","entity":"ndc:55513088002"},{"fact_id":"3c664fd7a5655318e83d0873","field":"drug.partd_spending","entity":"drug:romosozumab-aqqg|evenity"},{"fact_id":"93a1c7e26a35d04e0fb52ca5","field":"drug.partd_spending","entity":"drug:romosozumab-aqqg|evenity"},{"fact_id":"56677d64511b496415f4b6f0","field":"drug.partd_spending","entity":"drug:romosozumab-aqqg|evenity"},{"fact_id":"31079d76292d6a9b8618990e","field":"drug.partd_spending","entity":"drug:romosozumab-aqqg|evenity"},{"fact_id":"938ff82569e6d8707d22ba73","field":"drug.partd_spending","entity":"drug:romosozumab-aqqg|evenity"},{"fact_id":"01975a02cd9faca93b3a168a","field":"drug.biologic_status","entity":"application:BLA761062"},{"fact_id":"ac04c26244fb5463ac2b1308","field":"drug.asp_price","entity":"hcpcs:J3111"},{"fact_id":"5aa8bb4d47fa1c30bc0d1394","field":"drug.orphan_designation","entity":"drug:romosozumab"},{"fact_id":"de51a18a66eb374e7b97e2de","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513099802:CA"},{"fact_id":"4fff899b4b6bb5fc7eedceb2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513099802:SD"},{"fact_id":"57c98622ec50875ffd903ef9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513099802:NY"},{"fact_id":"360476cc0bafd12d39a41200","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513099802:AZ"},{"fact_id":"50c710681832f1fd2c046a78","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513099802:NJ"},{"fact_id":"35fd1c454a6b6c208e79a817","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513099802:MN"},{"fact_id":"92d1ce4ce6859d9e79b7712a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513099802:IL"},{"fact_id":"03b233de894455b5a3fb7907","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513099802:PA"},{"fact_id":"6e347580c8c22144df1e54cc","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513099802:IN"},{"fact_id":"d3d889db4f1f02a663b3e9ce","field":"ndc.medicaid_state_utilization","entity":"ndc_state:55513099802:CO"}],"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:BLA761062","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":"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":"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."}