{"answer":{"query":"Opzelura","resolved_as":"applications","packages":4,"applications":["NDA215309"],"identity":{"application_numbers":["NDA215309"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CREAM","untrusted":true}],"marketing_start":{"earliest":"2021-09-21","latest":"2025-11-10","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA215309","date":"2041-05-05","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled)","driver":{"kind":"patent","ref":"11602536","productNo":"001"},"latest_patent_expiry":"2041-05-05","latest_exclusivity_expiry":"2028-09-18","dated_barriers":36,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":22,"exclusivities_listed":3,"fact_id":"ea35e2a50fc2a9bf2e6e6f6b"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"LABELING":2,"EFFICACY":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA215309","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-30","documents":[{"type":"Letter","date":"2026-07-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215309Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-07-10","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215309s009sdn953lbl.pdf","untrusted":true}}],"fact_id":"cbc3c94a5ae323338bfa7203"},{"application":"NDA215309","submission_no":7,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-09-18","documents":[{"type":"Letter","date":"2025-09-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215309Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-09-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215309s007lbl.pdf","untrusted":true}}],"fact_id":"f8fe47fc7f7971a693019a4a"},{"application":"NDA215309","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-03-13","documents":[{"type":"Letter","date":"2023-03-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215309Orig1s004ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-03-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215309s004lbl.pdf","untrusted":true}}],"fact_id":"9b2be20e89ae4b5b453fd5ca"},{"application":"NDA215309","submission_no":1,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-07-18","documents":[{"type":"Letter","date":"2022-07-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215309Orig1s001ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-07-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215309s001lbl.pdf","untrusted":true}}],"fact_id":"8366cd40a2a736c2645cbf39"}],"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; 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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}}},"orphan_designation":{"ingredients":[{"ingredient":{"text":"Ruxolitinib; ruxolitinib","untrusted":true},"designation_count":8,"approved_count":6,"recent":[{"designated":"2016-11-03","use":{"text":"Treatment of graft versus host disease","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Incyte Corporation","untrusted":true},"approved":true},{"designated":"2016-11-03","use":{"text":"Treatment of graft versus host disease","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Incyte Corporation","untrusted":true},"approved":true},{"designated":"2016-11-03","use":{"text":"Treatment of graft versus host disease","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Incyte Corporation","untrusted":true},"approved":true},{"designated":"2016-07-18","use":{"text":"Treatment of acute lymphoblastic leukemia.","untrusted":true},"status":"Designated","sponsor":{"text":"Incyte Corporation","untrusted":true},"approved":false},{"designated":"2013-08-16","use":{"text":"Treatment of pancreatic cancer","untrusted":true},"status":"Designated","sponsor":{"text":"Incyte Corporation","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"4280398848c4dbde148bbcf2"}],"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":2,"all_states_medicaid_reimbursed_usd":354800.56,"all_states_medicaid_paid_prescriptions":173,"top_states":[{"state":"ME","medicaid_paid_prescriptions":99,"medicaid_reimbursed_usd":201928.87,"total_reimbursed_usd":201928.87,"packages":1,"covers":"all_record_types","fact_id":"dbe2b029a032acef98cdfbb5"},{"state":"OK","medicaid_paid_prescriptions":74,"medicaid_reimbursed_usd":152871.69,"total_reimbursed_usd":157356.17,"packages":1,"covers":"fee_for_service_only","fact_id":"149f1b9005f8801a4efe7f6f"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":1,"older_year_facts_not_used":37,"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":"f88abd2275152d03b433cecb","field":"ndc.listing","entity":"ndc:50881000704"},{"fact_id":"54611de84cd569e539e9f6c2","field":"ndc.listing","entity":"ndc:50881000705"},{"fact_id":"ecdcb641bc94b993a624550d","field":"ndc.listing","entity":"ndc:50881000707"},{"fact_id":"ea35e2a50fc2a9bf2e6e6f6b","field":"drug.generic_entry_earliest","entity":"application:NDA215309"},{"fact_id":"0397f8dfe0d1501c85f2867a","field":"drug.patent","entity":"application:NDA215309"},{"fact_id":"5d0a4e7bd166b619b9ffb402","field":"drug.exclusivity","entity":"application:NDA215309"},{"fact_id":"cbc3c94a5ae323338bfa7203","field":"drug.label_event","entity":"application:NDA215309"},{"fact_id":"f8fe47fc7f7971a693019a4a","field":"drug.label_event","entity":"application:NDA215309"},{"fact_id":"9b2be20e89ae4b5b453fd5ca","field":"drug.label_event","entity":"application:NDA215309"},{"fact_id":"8366cd40a2a736c2645cbf39","field":"drug.label_event","entity":"application:NDA215309"},{"fact_id":"d549e0adfae5a87cc1f0e47d","field":"drug.marketing_status","entity":"application:NDA215309"},{"fact_id":"dd98a8b47d598a3b9a844805","field":"drug.partd_spending","entity":"drug:ruxolitinib-phosphate|opzelura"},{"fact_id":"3d7da1efd0e14ff0c1d198a0","field":"drug.partd_spending","entity":"drug:ruxolitinib-phosphate|opzelura"},{"fact_id":"c05c7e40f664ac1eb685de64","field":"drug.partd_spending","entity":"drug:ruxolitinib-phosphate|opzelura"},{"fact_id":"859d94fe3c60280d85d44888","field":"drug.partd_spending","entity":"drug:ruxolitinib-phosphate|opzelura"},{"fact_id":"4280398848c4dbde148bbcf2","field":"drug.orphan_designation","entity":"drug:ruxolitinib"},{"fact_id":"dbe2b029a032acef98cdfbb5","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50881000705:ME"},{"fact_id":"149f1b9005f8801a4efe7f6f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50881000705:OK"}],"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":"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":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"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."}