{"answer":{"query":"Tresiba","resolved_as":"applications","packages":13,"applications":["BLA203314"],"identity":{"application_numbers":["BLA203314"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2015-09-25","latest":"2024-05-29","packages_with_a_start_date":13}},"label_history":{"events_total":10,"non_cmc_events":8,"counts_by_class":{"EFFICACY":4,"LABELING":4},"cmc_events":2,"recent_non_cmc_events":[{"application":"BLA203314","submission_no":20,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-07-01","documents":[{"type":"Letter","date":"2022-07-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203314Orig1s018, s020ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-07-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf","untrusted":true}}],"fact_id":"ed1a4a9a040ffa76c3142103"},{"application":"BLA203314","submission_no":18,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-07-01","documents":[{"type":"Letter","date":"2022-07-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203314Orig1s018, s020ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-07-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203314s018s020lbl.pdf","untrusted":true}}],"fact_id":"12201ddc6456ee27755dcebf"},{"application":"BLA203314","submission_no":16,"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/2019/203314Orig1s015, s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203314s015s016lbl.pdf","untrusted":true}}],"fact_id":"1e9ab75dadc9494751b3d66e"},{"application":"BLA203314","submission_no":15,"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/2019/203314s015s016lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203314Orig1s015, s016ltr.pdf","untrusted":true}}],"fact_id":"6173f82825853a60ec371838"},{"application":"BLA203314","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-11-21","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/203314Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/203314s010lbl.pdf","untrusted":true}}],"fact_id":"d4938d941e89688e07978085"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"NOT_PROVIDED":3},"marketing_status_counts":{"Prescription":3},"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":"BLA203314","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TRESIBA","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"1000 UNITS/10ML (100 UNITS/ML)","untrusted":true}},{"application":"BLA203314","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TRESIBA","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"300 UNITS/3ML (100 UNITS/ML)","untrusted":true}},{"application":"BLA203314","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TRESIBA","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"600 UNITS/3ML (200 UNITS/ML)","untrusted":true}}]},"recalls":{"recalls_total":3,"counts_by_class":{"Class I":3},"packages_of_these_applications":13,"most_recent":[{"recall_number":"D-0619-2021","classification":"Class I","status":"Terminated","report_date":"2021-04-21","recall_initiated":"2021-03-22","recalling_firm":{"text":"Novo Nordisk Inc","untrusted":true},"reason":{"text":"Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.","untrusted":true},"packages_named":6,"fact_id":"cc61aff7fd70c52ec7380897"},{"recall_number":"D-0620-2021","classification":"Class I","status":"Terminated","report_date":"2021-04-21","recall_initiated":"2021-03-22","recalling_firm":{"text":"Novo Nordisk Inc","untrusted":true},"reason":{"text":"Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.","untrusted":true},"packages_named":6,"fact_id":"e8d546963652446d3edae83e"},{"recall_number":"D-0621-2021","classification":"Class I","status":"Terminated","report_date":"2021-04-21","recall_initiated":"2021-03-22","recalling_firm":{"text":"Novo Nordisk Inc","untrusted":true},"reason":{"text":"Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.","untrusted":true},"packages_named":6,"fact_id":"f3590a3cb8061cca7e909688"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Novo Nordisk Patient Assistance Program","untrusted":true},"type":"manufacturer","url":"https://www.novocare.com/diabetes/help-with-costs/pap.html","status":{"state":"limited","effective":null,"applies_to":{"text":"2026 program year","untrusted":true},"detail":{"text":"Novo Nordisk states that Medicare beneficiaries with prescription drug coverage will no longer be eligible to receive Ozempic through its Patient Assistance Program, and that some medicines will no longer be part of the program for 2026 (the page points to a separate list of the medicines that remain covered).","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.novocare.com/diabetes/help-with-costs/pap.html","proof_state":"verified"},"needs_status_check":true,"has_offer":false},{"name":{"text":"Novo Nordisk Insulin Affordability Programs","untrusted":true},"type":"manufacturer","url":"https://www.novocare.com/diabetes/help-with-costs/help-with-insulin-costs/myinsulinrx.html","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 Degludec","untrusted":true},"brand":{"text":"Tresiba","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":17045867.93,"claims":22926,"beneficiaries":6731,"average_spending_per_claim_usd":743.51687734,"fact_id":"86b1b87ed1bf37629a15313b"},{"year":2021,"gross_spending_usd":22585101.75,"claims":29416,"beneficiaries":8757,"average_spending_per_claim_usd":767.78289876,"fact_id":"68c680566fb57f599c9c21b6"},{"year":2022,"gross_spending_usd":25802904.34,"claims":33541,"beneficiaries":9604,"average_spending_per_claim_usd":769.29442593,"fact_id":"9a51facd5b7e283566198b4e"},{"year":2023,"gross_spending_usd":27706471.09,"claims":35961,"beneficiaries":10460,"average_spending_per_claim_usd":770.45886071,"fact_id":"b413e32abe7eacbdfbe928d7"},{"year":2024,"gross_spending_usd":33499311.33,"claims":51551,"beneficiaries":15624,"average_spending_per_claim_usd":649.82854513,"fact_id":"0cc1a1b70a9d75f994f427b4"}],"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":"BLA203314","status":"Reference","name":{"text":"Tresiba","untrusted":true},"proper_name":{"text":"insulin degludec","untrusted":true},"license_status":"Licensed","approval_date":"2015-09-25","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":"d213945de89fc67688fe35be"}],"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":10,"all_states_medicaid_reimbursed_usd":507933.36,"all_states_medicaid_paid_prescriptions":2097,"top_states":[{"state":"IN","medicaid_paid_prescriptions":261,"medicaid_reimbursed_usd":116847.64,"total_reimbursed_usd":117710.96,"packages":1,"covers":"fee_for_service_only","fact_id":"bf85a8e64d5f7c61a3bda985"},{"state":"NV","medicaid_paid_prescriptions":580,"medicaid_reimbursed_usd":103638.12,"total_reimbursed_usd":117742.76,"packages":2,"covers":"fee_for_service_only","fact_id":"3e7ca59cf1e62dcd4e26de7e"},{"state":"ID","medicaid_paid_prescriptions":463,"medicaid_reimbursed_usd":78012.42,"total_reimbursed_usd":78743.17,"packages":1,"covers":"all_record_types","fact_id":"29ba646925556568ead49ae5"},{"state":"UT","medicaid_paid_prescriptions":131,"medicaid_reimbursed_usd":63833.55,"total_reimbursed_usd":63833.55,"packages":2,"covers":"fee_for_service_only","fact_id":"558ef56c4fe741b384a48da2"},{"state":"CO","medicaid_paid_prescriptions":70,"medicaid_reimbursed_usd":52004.31,"total_reimbursed_usd":53413.31,"packages":1,"covers":"fee_for_service_only","fact_id":"c9278e8d8f4c23d70d83d430"},{"state":"AZ","medicaid_paid_prescriptions":219,"medicaid_reimbursed_usd":38657.62,"total_reimbursed_usd":38819.17,"packages":1,"covers":"fee_for_service_only","fact_id":"cf83442356d0de24ab2795b3"},{"state":"NY","medicaid_paid_prescriptions":63,"medicaid_reimbursed_usd":24319.04,"total_reimbursed_usd":27537.18,"packages":1,"covers":"fee_for_service_only","fact_id":"35113cfca9415345c70e9dc7"},{"state":"DC","medicaid_paid_prescriptions":87,"medicaid_reimbursed_usd":14556.49,"total_reimbursed_usd":16128.37,"packages":1,"covers":"fee_for_service_only","fact_id":"3d610ba93c1c650deb1b127a"},{"state":"DE","medicaid_paid_prescriptions":71,"medicaid_reimbursed_usd":10054.15,"total_reimbursed_usd":10552.86,"packages":1,"covers":"fee_for_service_only","fact_id":"50060b029dbe2f525eb68c6c"},{"state":"MO","medicaid_paid_prescriptions":152,"medicaid_reimbursed_usd":6010.02,"total_reimbursed_usd":7511.08,"packages":1,"covers":"all_record_types","fact_id":"73a45f79344f3f54bcb92934"}],"unlabelled_state_code_xx":null,"built_from_facts":12,"facts_fee_for_service_only":9,"older_year_facts_not_used":194,"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). 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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:BLA203314","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":"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."}