{"answer":{"query":"Miebo","resolved_as":"applications","packages":3,"applications":["NDA216675"],"identity":{"application_numbers":["NDA216675"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2023-05-18","latest":"2024-07-19","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA216675","date":"2037-06-21","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":"RE50060","productNo":"001"},"latest_patent_expiry":"2037-06-21","latest_exclusivity_expiry":"2028-05-18","dated_barriers":10,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":9,"exclusivities_listed":1,"fact_id":"09e52de8934cc277387d316f"}],"label_history":{"events_total":1,"non_cmc_events":1,"counts_by_class":{"LABELING":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA216675","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-10-21","documents":[{"type":"Label","date":"2025-10-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216675s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216675Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"064b20acebcf31b36516e7f8"}],"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}}},"medicaid_state_utilization":{"year":2025,"states_with_data":12,"all_states_medicaid_reimbursed_usd":2307860.88,"all_states_medicaid_paid_prescriptions":3229,"top_states":[{"state":"MA","medicaid_paid_prescriptions":799,"medicaid_reimbursed_usd":594115.7,"total_reimbursed_usd":610788.04,"packages":1,"covers":"all_record_types","fact_id":"9b0d9a52b6786a32e811a656"},{"state":"MI","medicaid_paid_prescriptions":572,"medicaid_reimbursed_usd":432242.87,"total_reimbursed_usd":432242.87,"packages":1,"covers":"fee_for_service_only","fact_id":"1dce017b90f1ddacdfc4408f"},{"state":"CO","medicaid_paid_prescriptions":557,"medicaid_reimbursed_usd":358351.22,"total_reimbursed_usd":358351.22,"packages":1,"covers":"fee_for_service_only","fact_id":"16da90eb2e67f8cd1ce3c4ff"},{"state":"IA","medicaid_paid_prescriptions":226,"medicaid_reimbursed_usd":180804.54,"total_reimbursed_usd":180804.54,"packages":1,"covers":"all_record_types","fact_id":"0f56d693a08481f43f492f45"},{"state":"NV","medicaid_paid_prescriptions":177,"medicaid_reimbursed_usd":137685.49,"total_reimbursed_usd":140693.98,"packages":1,"covers":"all_record_types","fact_id":"e56da934e44da95044dc7888"},{"state":"WI","medicaid_paid_prescriptions":141,"medicaid_reimbursed_usd":128253.33,"total_reimbursed_usd":128712.83,"packages":1,"covers":"all_record_types","fact_id":"bb96e34166a8d12fa3157515"},{"state":"ME","medicaid_paid_prescriptions":118,"medicaid_reimbursed_usd":98867.12,"total_reimbursed_usd":102302.36,"packages":1,"covers":"all_record_types","fact_id":"f30dcb19007915215c901805"},{"state":"MD","medicaid_paid_prescriptions":122,"medicaid_reimbursed_usd":91158.7,"total_reimbursed_usd":91515.7,"packages":1,"covers":"fee_for_service_only","fact_id":"40197abb75b935fcd95f4c83"},{"state":"SD","medicaid_paid_prescriptions":104,"medicaid_reimbursed_usd":81692.2,"total_reimbursed_usd":81692.2,"packages":1,"covers":"all_record_types","fact_id":"49dadf94151355308c7b582a"},{"state":"RI","medicaid_paid_prescriptions":102,"medicaid_reimbursed_usd":79215.36,"total_reimbursed_usd":79215.36,"packages":1,"covers":"all_record_types","fact_id":"7ede4674d58fa67f4baf51d1"}],"unlabelled_state_code_xx":null,"built_from_facts":12,"facts_fee_for_service_only":4,"older_year_facts_not_used":17,"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":"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":"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."}