{"answer":{"query":"Dupixent","resolved_as":"applications","packages":8,"applications":["BLA761055"],"identity":{"application_numbers":["BLA761055"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2017-03-28","latest":"2021-06-14","packages_with_a_start_date":8}},"label_history":{"events_total":32,"non_cmc_events":32,"counts_by_class":{"LABELING":13,"EFFICACY":19},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761055","submission_no":76,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-07-15","documents":[{"type":"Label","date":"2026-09-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055Orig1s076lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-09-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761055Orig1s076ltr.pdf","untrusted":true}}],"fact_id":"c92dd2d8129966d0d59afa96"},{"application":"BLA761055","submission_no":74,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-04-22","documents":[{"type":"Letter","date":"2026-04-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761055Orig1s074ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-04-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s074lbl.pdf","untrusted":true}}],"fact_id":"f92a694fa9c884fcda1dab36"},{"application":"BLA761055","submission_no":82,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-04-16","documents":[{"type":"Letter","date":"2026-04-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761055Orig1s082ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-04-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s082lbl.pdf","untrusted":true}}],"fact_id":"10dc5296de2a71a82c6fd3b1"},{"application":"BLA761055","submission_no":75,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-02-23","documents":[{"type":"Label","date":"2026-02-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/761055s075lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-02-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761055Orig1s075ltr.pdf","untrusted":true}}],"fact_id":"2be920e8af85c3886d646ccc"},{"application":"BLA761055","submission_no":70,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-06-18","documents":[{"type":"Label","date":"2025-06-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761055s070lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-06-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761055Orig1s070ltr.pdf","untrusted":true}}],"fact_id":"c0f3785cbdafd1c1c4c81a06"}],"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":"BLA761055","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"DUPIXENT","untrusted":true},"form":{"text":"INJECTABLE; INJECTION","untrusted":true},"strength":{"text":"150MG/ML","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":8,"most_recent":[{"recall_number":"D-0760-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"344732045fc8c8789bb7ff34"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Regeneron/Sanofi Dupixent MyWay","untrusted":true},"type":"manufacturer","url":"https://www.dupixent.com/support-savings/dupixent-my-way","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"Dupixent Copay Card","untrusted":true},"type":"manufacturer","url":"https://www.dupixent.com/support-savings/copay-card-insurance","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"HealthWell Foundation","untrusted":true},"type":"nonprofit","url":"https://www.healthwellfoundation.org/","status":{"state":"limited","effective":null,"applies_to":{"text":"HealthWell Foundation disease funds, as listed on the homepage when read","untrusted":true},"detail":{"text":"The HealthWell Foundation homepage lists disease funds as Open or Closed when read. Closed funds include Type 2 Diabetes, Migraine and Multiple Sclerosis - Medicare Access; open funds include Multiple Myeloma - Medicare Access, which the page says offers up to $8,000 in prescription drug copayment or Medicare Part B premium assistance. The page carries no fund-level date; the status is as of the read.","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.healthwellfoundation.org/","proof_state":"verified"},"needs_status_check":true,"has_offer":false},{"name":{"text":"Good Days (formerly Chronic Disease Fund)","untrusted":true},"type":"nonprofit","url":"https://www.mygooddays.org/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"TAF Cares (The Assistance Fund)","untrusted":true},"type":"nonprofit","url":"https://tafcares.org/","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."},"biologic_status":{"products":[{"application":"BLA761055","status":"Reference","name":{"text":"Dupixent","untrusted":true},"proper_name":{"text":"dupilumab","untrusted":true},"license_status":"Licensed","approval_date":"2017-03-28","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":"d78b9a9d7045a581c4f4b643"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"dupilumab","untrusted":true},"designation_count":4,"approved_count":3,"recent":[{"designated":"2026-07-14","use":{"text":"treatment of Netherton syndrome (NS)","untrusted":true},"status":"Designated","sponsor":{"text":"Regeneron Pharmaceuticals, Inc.","untrusted":true},"approved":false},{"designated":"2019-08-21","use":{"text":"Treatment of bullous pemphigoid","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Regeneron Pharmaceuticals, Inc.","untrusted":true},"approved":true},{"designated":"2017-09-05","use":{"text":"Treatment of eosinophilic esophagitis","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Regeneron Pharmaceuticals, Inc.","untrusted":true},"approved":true},{"designated":"2017-09-05","use":{"text":"Treatment of eosinophilic esophagitis","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Regeneron Pharmaceuticals, Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"604942522d98983b367c332e"}],"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":4,"all_states_medicaid_reimbursed_usd":5249924.56,"all_states_medicaid_paid_prescriptions":1557,"top_states":[{"state":"OH","medicaid_paid_prescriptions":1287,"medicaid_reimbursed_usd":4482710.51,"total_reimbursed_usd":4624358.72,"packages":1,"covers":"fee_for_service_only","fact_id":"e519c0f3492558018c02d1c3"},{"state":"UT","medicaid_paid_prescriptions":117,"medicaid_reimbursed_usd":463945.85,"total_reimbursed_usd":482001.76,"packages":1,"covers":"fee_for_service_only","fact_id":"b20822a3f1fa49c587599157"},{"state":"VT","medicaid_paid_prescriptions":79,"medicaid_reimbursed_usd":303174.56,"total_reimbursed_usd":303174.56,"packages":1,"covers":"all_record_types","fact_id":"5e3a32a92027ab8925bf17fe"},{"state":"TN","medicaid_paid_prescriptions":74,"medicaid_reimbursed_usd":93.64,"total_reimbursed_usd":93.64,"packages":1,"covers":"all_record_types","fact_id":"c7c1de7e55fdb3c89a25aef8"}],"unlabelled_state_code_xx":null,"built_from_facts":4,"facts_fee_for_service_only":2,"older_year_facts_not_used":206,"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":"64567eecf2b24047f18348df","field":"ndc.listing","entity":"ndc:00024591401"},{"fact_id":"5dae3454383a0963b9f8b570","field":"ndc.listing","entity":"ndc:00024591402"},{"fact_id":"28e807b25cff790f2b831b7b","field":"ndc.listing","entity":"ndc:00024591502"},{"fact_id":"c92dd2d8129966d0d59afa96","field":"drug.label_event","entity":"application:BLA761055"},{"fact_id":"f92a694fa9c884fcda1dab36","field":"drug.label_event","entity":"application:BLA761055"},{"fact_id":"10dc5296de2a71a82c6fd3b1","field":"drug.label_event","entity":"application:BLA761055"},{"fact_id":"2be920e8af85c3886d646ccc","field":"drug.label_event","entity":"application:BLA761055"},{"fact_id":"c0f3785cbdafd1c1c4c81a06","field":"drug.label_event","entity":"application:BLA761055"},{"fact_id":"ece2f1d50f69d82fa9133540","field":"drug.marketing_status","entity":"application:BLA761055"},{"fact_id":"344732045fc8c8789bb7ff34","field":"ndc.recall","entity":"ndc:00024591401"},{"fact_id":"5918f8fc0a9c66589584d99b","field":"program.status","entity":"program:healthwell-foundation"},{"fact_id":"d78b9a9d7045a581c4f4b643","field":"drug.biologic_status","entity":"application:BLA761055"},{"fact_id":"604942522d98983b367c332e","field":"drug.orphan_designation","entity":"drug:dupilumab"},{"fact_id":"e519c0f3492558018c02d1c3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024591902:OH"},{"fact_id":"b20822a3f1fa49c587599157","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024591902:UT"},{"fact_id":"5e3a32a92027ab8925bf17fe","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024591902:VT"},{"fact_id":"c7c1de7e55fdb3c89a25aef8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024591402:TN"}],"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:BLA761055","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":"NO_DATA","field":"spending","reason":"no CMS Part D spending series for this brand name is in the edition"},{"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":"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."}