{"answer":{"query":"Lantus","resolved_as":"applications","packages":7,"applications":["BLA021081"],"identity":{"application_numbers":["BLA021081"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2009-09-23","latest":"2019-01-17","packages_with_a_start_date":7}},"label_history":{"events_total":28,"non_cmc_events":13,"counts_by_class":{"LABELING":9,"EFFICACY":4},"cmc_events":15,"recent_non_cmc_events":[{"application":"BLA021081","submission_no":79,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-06-29","documents":[{"type":"Label","date":"2023-06-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021081s078s079lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-06-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021081Orig1s078,s079ltr.pdf","untrusted":true}}],"fact_id":"1d8e0b742be37a6f7c881f44"},{"application":"BLA021081","submission_no":78,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-06-29","documents":[{"type":"Label","date":"2023-06-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021081s078s079lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-06-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021081Orig1s078,s079ltr.pdf","untrusted":true}}],"fact_id":"f0543bb0998540b7d30eec34"},{"application":"BLA021081","submission_no":76,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-06-07","documents":[{"type":"Letter","date":"2022-06-08","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021081Orig1s076ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-06-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021081s076lbl.pdf","untrusted":true}}],"fact_id":"d32bb1dd84f75302cd33fa4d"},{"application":"BLA021081","submission_no":74,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-11-15","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf","untrusted":true}}],"fact_id":"8e9dc33fb28cc68b79848188"},{"application":"BLA021081","submission_no":73,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-11-15","documents":[{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021081s073s074lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021081Orig1s073, s074; 021629Orig1s039, s040; 206538Orig1s013, s014ltr.pdf","untrusted":true}}],"fact_id":"e80b3cad8596cfcc6675b684"}],"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":"BLA021081","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"LANTUS","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"100 UNITS/ML","untrusted":true}},{"application":"BLA021081","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"LANTUS SOLOSTAR","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"300 UNITS/3ML (100 UNITS/ML)","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Lilly Cares Foundation","untrusted":true},"type":"manufacturer","url":"https://www.lillycares.com/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"Sanofi Patient Connection","untrusted":true},"type":"manufacturer","url":"https://www.sanofipatientconnection.com/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"Lilly Insulin Value Program","untrusted":true},"type":"manufacturer","url":"https://www.insulinaffordability.com/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"Sanofi Insulin Valyou Savings Program","untrusted":true},"type":"manufacturer","url":"https://www.sanofipatientconnection.com/","status":null,"needs_status_check":false,"has_offer":false}],"manufacturer_offers":[],"note":"A program that lists a drug has not decided anything about any person: each program decides who qualifies, and a status other than open means it may not take new patients. Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Insulin Glargine,Hum.Rec.Anlog","untrusted":true},"brand":{"text":"Lantus","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":1055722607,"claims":1821215,"beneficiaries":378001,"average_spending_per_claim_usd":579.68038204,"fact_id":"4e18532244334969f1011487"},{"year":2021,"gross_spending_usd":958653939.4,"claims":1606778,"beneficiaries":347108,"average_spending_per_claim_usd":596.63123306,"fact_id":"6eba28067dfccf1f26d31079"},{"year":2022,"gross_spending_usd":833484770.49,"claims":1380803,"beneficiaries":306049,"average_spending_per_claim_usd":603.62323263,"fact_id":"1e703b887b495c524e3f6a88"},{"year":2023,"gross_spending_usd":735735411.45,"claims":1178123,"beneficiaries":279981,"average_spending_per_claim_usd":624.49796112,"fact_id":"9b247c043ed1495c2a74dd58"},{"year":2024,"gross_spending_usd":139894057.11,"claims":1116800,"beneficiaries":271761,"average_spending_per_claim_usd":125.26330329,"fact_id":"65b8f4a1fbe8da9db173fa0b"}],"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":"BLA021081","status":"Reference","name":{"text":"Lantus","untrusted":true},"proper_name":{"text":"insulin glargine","untrusted":true},"license_status":"Licensed","approval_date":"2000-04-20","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":3,"biosimilars":[],"interchangeables":[{"name":{"text":"Semglee","untrusted":true},"proper_name":{"text":"insulin glargine-yfgn","untrusted":true},"bla_number":"761201","approval_date":"2021-07-28","interchangeable_date":"2021-07-28"},{"name":{"text":"Rezvoglar","untrusted":true},"proper_name":{"text":"insulin glargine-aglr","untrusted":true},"bla_number":"761215","approval_date":"2021-12-17","interchangeable_date":"2022-11-16"},{"name":{"text":"Langlara","untrusted":true},"proper_name":{"text":"insulin glargine-aldy","untrusted":true},"bla_number":"761412","approval_date":"2026-04-29","interchangeable_date":"2026-04-29"}],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"a45c88f8361ca19eb44b8d2d"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"medicaid_state_utilization":{"year":2024,"states_with_data":52,"all_states_medicaid_reimbursed_usd":285003733.18,"all_states_medicaid_paid_prescriptions":2605238,"top_states":[{"state":"CA","medicaid_paid_prescriptions":196145,"medicaid_reimbursed_usd":24089717.28,"total_reimbursed_usd":24577410.3,"packages":2,"covers":"all_record_types","fact_id":"cbf00ef4ef3bba3f2a2f5ced"},{"state":"NY","medicaid_paid_prescriptions":187970,"medicaid_reimbursed_usd":20196372.99,"total_reimbursed_usd":20445725.92,"packages":2,"covers":"all_record_types","fact_id":"f65b0fa310d287a6ada8749b"},{"state":"OH","medicaid_paid_prescriptions":163336,"medicaid_reimbursed_usd":18650719.3,"total_reimbursed_usd":18788136.82,"packages":2,"covers":"fee_for_service_only","fact_id":"6d43352ed4d6131a26a178af"},{"state":"PA","medicaid_paid_prescriptions":176297,"medicaid_reimbursed_usd":17589304.6,"total_reimbursed_usd":17991526.46,"packages":2,"covers":"all_record_types","fact_id":"8a529e0da26fca12ab4b7dc0"},{"state":"IL","medicaid_paid_prescriptions":137200,"medicaid_reimbursed_usd":15892360.35,"total_reimbursed_usd":15975588.5,"packages":2,"covers":"all_record_types","fact_id":"bcf46c351d1f60d8f1954aa3"},{"state":"MI","medicaid_paid_prescriptions":138011,"medicaid_reimbursed_usd":15589474.26,"total_reimbursed_usd":15653682.18,"packages":2,"covers":"all_record_types","fact_id":"e07c119fec9fd50f8d3c3dd7"},{"state":"PR","medicaid_paid_prescriptions":124049,"medicaid_reimbursed_usd":10858497.5,"total_reimbursed_usd":10883247.17,"packages":2,"covers":"all_record_types","fact_id":"d3b8ac09d3366198c169f5a8"},{"state":"MO","medicaid_paid_prescriptions":75922,"medicaid_reimbursed_usd":10023683.39,"total_reimbursed_usd":10052829.72,"packages":2,"covers":"all_record_types","fact_id":"88f8219fd5d6036ffe51e0d9"},{"state":"AZ","medicaid_paid_prescriptions":95863,"medicaid_reimbursed_usd":9765868.3,"total_reimbursed_usd":9859560.07,"packages":2,"covers":"all_record_types","fact_id":"f2baa4bc6608b371267e64ac"},{"state":"FL","medicaid_paid_prescriptions":100552,"medicaid_reimbursed_usd":9409037.19,"total_reimbursed_usd":9437450.99,"packages":2,"covers":"all_record_types","fact_id":"8f4a27bc869ca03b61027506"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":2621200,"medicaid_reimbursed_usd":286895503.93,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":106,"facts_fee_for_service_only":19,"older_year_facts_not_used":0,"dataset":"State Drug Utilization Data 2024","read_on":"2026-11-07T23:59:45.983Z","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":"a2fedc15e9e39c08c5ca0bd1","field":"ndc.listing","entity":"ndc:00088221900"},{"fact_id":"4cf042af4cea530e0fdaf623","field":"ndc.listing","entity":"ndc:00088221905"},{"fact_id":"cd6e128b65f61b3d852dc36c","field":"ndc.listing","entity":"ndc:00088222033"},{"fact_id":"1d8e0b742be37a6f7c881f44","field":"drug.label_event","entity":"application:BLA021081"},{"fact_id":"f0543bb0998540b7d30eec34","field":"drug.label_event","entity":"application:BLA021081"},{"fact_id":"d32bb1dd84f75302cd33fa4d","field":"drug.label_event","entity":"application:BLA021081"},{"fact_id":"8e9dc33fb28cc68b79848188","field":"drug.label_event","entity":"application:BLA021081"},{"fact_id":"e80b3cad8596cfcc6675b684","field":"drug.label_event","entity":"application:BLA021081"},{"fact_id":"ec4bbc94055c554d43cfdba5","field":"drug.marketing_status","entity":"application:BLA021081"},{"fact_id":"838a1c81337b00a5bfad02c7","field":"drug.marketing_status","entity":"application:BLA021081"},{"fact_id":"4e18532244334969f1011487","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|lantus"},{"fact_id":"6eba28067dfccf1f26d31079","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|lantus"},{"fact_id":"1e703b887b495c524e3f6a88","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|lantus"},{"fact_id":"9b247c043ed1495c2a74dd58","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|lantus"},{"fact_id":"65b8f4a1fbe8da9db173fa0b","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|lantus"},{"fact_id":"a45c88f8361ca19eb44b8d2d","field":"drug.biologic_status","entity":"application:BLA021081"},{"fact_id":"fe5ac5e40e0cf97ebf180274","field":"drug.biologic_status","entity":"application:BLA761201"},{"fact_id":"8d25776cd9407289cb73490a","field":"drug.biologic_status","entity":"application:BLA761215"},{"fact_id":"258f6cccc8f0cb90cf98f37b","field":"drug.biologic_status","entity":"application:BLA761412"},{"fact_id":"cbf00ef4ef3bba3f2a2f5ced","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00088221905:CA"},{"fact_id":"f65b0fa310d287a6ada8749b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00088221905:NY"},{"fact_id":"6d43352ed4d6131a26a178af","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00088221905:OH"},{"fact_id":"8a529e0da26fca12ab4b7dc0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00088221905:PA"},{"fact_id":"bcf46c351d1f60d8f1954aa3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00088221905:IL"},{"fact_id":"e07c119fec9fd50f8d3c3dd7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00088221905:MI"},{"fact_id":"d3b8ac09d3366198c169f5a8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00088222033:PR"},{"fact_id":"88f8219fd5d6036ffe51e0d9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00088221905:MO"},{"fact_id":"f2baa4bc6608b371267e64ac","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00088221905:AZ"},{"fact_id":"8f4a27bc869ca03b61027506","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00088221905: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:BLA021081","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":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"AMBIGUOUS","field":"spending","reason":"2 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"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."}