{"answer":{"query":"Levemir","resolved_as":"applications","packages":1,"applications":["BLA021536"],"identity":{"application_numbers":["BLA021536"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2014-11-28","latest":"2014-11-28","packages_with_a_start_date":1}},"label_history":{"events_total":27,"non_cmc_events":22,"counts_by_class":{"LABELING":19,"EFFICACY":3},"cmc_events":5,"recent_non_cmc_events":[{"application":"BLA021536","submission_no":62,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-12-08","documents":[{"type":"Label","date":"2022-12-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf","untrusted":true}},{"type":"Letter","date":"2022-12-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021536Orig1s062ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-12-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s062lbl.pdf","untrusted":true}}],"fact_id":"5431b532c2fc9f3f34697377"},{"application":"BLA021536","submission_no":60,"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/2022/021536Orig1s060ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-07-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021536s060lbl.pdf","untrusted":true}}],"fact_id":"42a45e22efecfef5369922ca"},{"application":"BLA021536","submission_no":56,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-12-27","documents":[{"type":"Label","date":"2020-03-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s056lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021536Orig1s056ltr.pdf","untrusted":true}}],"fact_id":"f9751e315a5cef19afaec937"},{"application":"BLA021536","submission_no":58,"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/2019/021536s057s058lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021536Orig1s057, s058ltr.pdf","untrusted":true}}],"fact_id":"d50ab00b243db271f1d018d9"},{"application":"BLA021536","submission_no":57,"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/2019/021536Orig1s057, s058ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021536s057s058lbl.pdf","untrusted":true}}],"fact_id":"ff92c62c7d2327b89a9ed712"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":5,"te_code_counts":{"NOT_PROVIDED":5},"marketing_status_counts":{"Discontinued":3,"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":"BLA021536","product_no":"002","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"LEVEMIR FLEXPEN","untrusted":true},"form":{"text":"INJECTABLE;SUBCUTANEOUS","untrusted":true},"strength":{"text":"300 UNITS/3ML (100 UNITS/ML)","untrusted":true}},{"application":"BLA021536","product_no":"005","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"LEVEMIR FLEXTOUCH","untrusted":true},"form":{"text":"INJECTABLE;SUBCUTANEOUS","untrusted":true},"strength":{"text":"300 UNITS/3ML (100 UNITS/ML)","untrusted":true}},{"application":"BLA021536","product_no":"003","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"LEVEMIR INNOLET","untrusted":true},"form":{"text":"INJECTABLE;SUBCUTANEOUS","untrusted":true},"strength":{"text":"300 UNITS/3ML (100 UNITS/ML)","untrusted":true}},{"application":"BLA021536","product_no":"004","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"LEVEMIR PENFILL","untrusted":true},"form":{"text":"INJECTABLE;SUBCUTANEOUS","untrusted":true},"strength":{"text":"300 UNITS/3ML (100 UNITS/ML)","untrusted":true}},{"application":"BLA021536","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"LEVEMIR","untrusted":true},"form":{"text":"INJECTABLE;SUBCUTANEOUS","untrusted":true},"strength":{"text":"1000 UNITS/10ML (100 UNITS/ML)","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Insulin Detemir","untrusted":true},"brand":{"text":"Levemir","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":436907522.69,"claims":704341,"beneficiaries":135263,"average_spending_per_claim_usd":620.30681543,"fact_id":"f0fc53e79a033b313976d6ac"},{"year":2021,"gross_spending_usd":373910076.9,"claims":579211,"beneficiaries":118234,"average_spending_per_claim_usd":645.55071796,"fact_id":"49fb01a0fea8bf0f984e8e73"},{"year":2022,"gross_spending_usd":319727025.36,"claims":484393,"beneficiaries":98353,"average_spending_per_claim_usd":660.05707217,"fact_id":"9df04d484c4f073529dc5cb0"},{"year":2023,"gross_spending_usd":287253250.1,"claims":427861,"beneficiaries":90227,"average_spending_per_claim_usd":671.37049205,"fact_id":"d4aeb416518e2325bde0f9b3"},{"year":2024,"gross_spending_usd":30621216.73,"claims":142657,"beneficiaries":48292,"average_spending_per_claim_usd":214.6492407,"fact_id":"6792e08fa99aed7fc119b2b2"}],"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":"BLA021536","status":"Reference","name":{"text":"Levemir","untrusted":true},"proper_name":{"text":"insulin detemir","untrusted":true},"license_status":"Licensed","approval_date":"2005-06-16","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":"743fdfa260dfa23b778feaf9"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"}},"receipts":[{"fact_id":"0e64d050e539c587dc894bef","field":"ndc.listing","entity":"ndc:50090127600"},{"fact_id":"5431b532c2fc9f3f34697377","field":"drug.label_event","entity":"application:BLA021536"},{"fact_id":"42a45e22efecfef5369922ca","field":"drug.label_event","entity":"application:BLA021536"},{"fact_id":"f9751e315a5cef19afaec937","field":"drug.label_event","entity":"application:BLA021536"},{"fact_id":"d50ab00b243db271f1d018d9","field":"drug.label_event","entity":"application:BLA021536"},{"fact_id":"ff92c62c7d2327b89a9ed712","field":"drug.label_event","entity":"application:BLA021536"},{"fact_id":"c67cd30d96fd1b4cbec0c999","field":"drug.marketing_status","entity":"application:BLA021536"},{"fact_id":"c3e2302d6a9394c76ddc9daf","field":"drug.marketing_status","entity":"application:BLA021536"},{"fact_id":"b40ab4adf40e4af4d6b524d3","field":"drug.marketing_status","entity":"application:BLA021536"},{"fact_id":"2fa7e68dd13bcdf6ac8466b1","field":"drug.marketing_status","entity":"application:BLA021536"},{"fact_id":"2c16af1d30a67695bcce22af","field":"drug.marketing_status","entity":"application:BLA021536"},{"fact_id":"f0fc53e79a033b313976d6ac","field":"drug.partd_spending","entity":"drug:insulin-detemir|levemir"},{"fact_id":"49fb01a0fea8bf0f984e8e73","field":"drug.partd_spending","entity":"drug:insulin-detemir|levemir"},{"fact_id":"9df04d484c4f073529dc5cb0","field":"drug.partd_spending","entity":"drug:insulin-detemir|levemir"},{"fact_id":"d4aeb416518e2325bde0f9b3","field":"drug.partd_spending","entity":"drug:insulin-detemir|levemir"},{"fact_id":"6792e08fa99aed7fc119b2b2","field":"drug.partd_spending","entity":"drug:insulin-detemir|levemir"},{"fact_id":"743fdfa260dfa23b778feaf9","field":"drug.biologic_status","entity":"application:BLA021536"}],"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:BLA021536","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":"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"},{"code":"NO_DATA","field":"medicaid_state_utilization","reason":"no CMS State Drug Utilization figure for this drug's packages is in the edition (suppressed, out of scope or unreported)"}],"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."}