{"answer":{"query":"Soliqua","resolved_as":"applications","packages":2,"applications":["BLA208673"],"identity":{"application_numbers":["BLA208673"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2016-11-21","latest":"2016-11-21","packages_with_a_start_date":2}},"label_history":{"events_total":11,"non_cmc_events":10,"counts_by_class":{"LABELING":9,"EFFICACY":1},"cmc_events":1,"recent_non_cmc_events":[{"application":"BLA208673","submission_no":23,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-03-12","documents":[{"type":"Letter","date":"2026-03-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208673Orig1s023ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208673s023lbl.pdf","untrusted":true}}],"fact_id":"cee9108820373f9096f4e7ef"},{"application":"BLA208673","submission_no":18,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-05-28","documents":[{"type":"Letter","date":"2025-05-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208673Orig1s018ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-06-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208673s018lbl.pdf","untrusted":true}}],"fact_id":"2cce91b81e9864bac98b270f"},{"application":"BLA208673","submission_no":14,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-11-01","documents":[{"type":"Label","date":"2024-11-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208673s014lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-11-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208673Orig1s014ltr.pdf","untrusted":true}}],"fact_id":"5711461ac550cfcb0cab6625"},{"application":"BLA208673","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-09-28","documents":[{"type":"Label","date":"2023-09-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208673s013lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-09-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208673Orig1s013ltr.pdf","untrusted":true}}],"fact_id":"c96b4fa2bd1480b23e624f06"},{"application":"BLA208673","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-06-10","documents":[{"type":"Letter","date":"2022-06-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208673Orig1s012ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-06-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208673s012lbl.pdf","untrusted":true}}],"fact_id":"794064c87105dc5f1c99da27"}],"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":"BLA208673","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SOLIQUA 100/33","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/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":"Insulin Glargine","untrusted":true}},"latest_year":2024,"series":[{"year":2022,"gross_spending_usd":1131425.33,"claims":7964,"beneficiaries":4842,"average_spending_per_claim_usd":142.06746986,"fact_id":"3864f0dfd9f36a5b61003e0a"},{"year":2023,"gross_spending_usd":7523782.18,"claims":51328,"beneficiaries":26391,"average_spending_per_claim_usd":146.58241467,"fact_id":"b9b9ae5c53aaafbc50b12c1f"},{"year":2024,"gross_spending_usd":2703443.64,"claims":18156,"beneficiaries":10711,"average_spending_per_claim_usd":148.90083939,"fact_id":"4a04b58e31d883c1b36c5da3"}],"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":"BLA208673","status":"Reference","name":{"text":"Soliqua 100/33","untrusted":true},"proper_name":{"text":"insulin glargine and lixisenatide","untrusted":true},"license_status":"Licensed","approval_date":"2016-11-21","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":"e587e7f8bcafbc94c1299ba0"}],"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":2025,"states_with_data":2,"all_states_medicaid_reimbursed_usd":151412.83,"all_states_medicaid_paid_prescriptions":216,"top_states":[{"state":"UT","medicaid_paid_prescriptions":157,"medicaid_reimbursed_usd":112809.05,"total_reimbursed_usd":112809.08,"packages":1,"covers":"fee_for_service_only","fact_id":"2ee875c4ee777be584d6aee4"},{"state":"AL","medicaid_paid_prescriptions":59,"medicaid_reimbursed_usd":38603.78,"total_reimbursed_usd":45817.14,"packages":1,"covers":"all_record_types","fact_id":"758f2855390801d2e494766d"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":1,"older_year_facts_not_used":27,"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":"dcbf8489afd9400d77ebdeba","field":"ndc.listing","entity":"ndc:00024576101"},{"fact_id":"79822f38f9a78f4ee3c53a54","field":"ndc.listing","entity":"ndc:00024576105"},{"fact_id":"cee9108820373f9096f4e7ef","field":"drug.label_event","entity":"application:BLA208673"},{"fact_id":"2cce91b81e9864bac98b270f","field":"drug.label_event","entity":"application:BLA208673"},{"fact_id":"5711461ac550cfcb0cab6625","field":"drug.label_event","entity":"application:BLA208673"},{"fact_id":"c96b4fa2bd1480b23e624f06","field":"drug.label_event","entity":"application:BLA208673"},{"fact_id":"794064c87105dc5f1c99da27","field":"drug.label_event","entity":"application:BLA208673"},{"fact_id":"f476f4454ba6287929c0c7ee","field":"drug.marketing_status","entity":"application:BLA208673"},{"fact_id":"3864f0dfd9f36a5b61003e0a","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|insulin-glargine"},{"fact_id":"b9b9ae5c53aaafbc50b12c1f","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|insulin-glargine"},{"fact_id":"4a04b58e31d883c1b36c5da3","field":"drug.partd_spending","entity":"drug:insulin-glargine-hum-rec-anlog|insulin-glargine"},{"fact_id":"e587e7f8bcafbc94c1299ba0","field":"drug.biologic_status","entity":"application:BLA208673"},{"fact_id":"2ee875c4ee777be584d6aee4","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024576105:UT"},{"fact_id":"758f2855390801d2e494766d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024576105:AL"}],"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:BLA208673","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":"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."}