{"answer":{"query":"Multaq","resolved_as":"applications","packages":4,"applications":["NDA022425"],"identity":{"application_numbers":["NDA022425"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2009-07-01","latest":"2024-06-01","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA022425","date":"2031-06-30","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":"8602215","productNo":"001"},"latest_patent_expiry":"2031-06-30","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":3,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":0,"fact_id":"db9d1da9025cf6ee63d865ea"}],"label_history":{"events_total":23,"non_cmc_events":22,"counts_by_class":{"EFFICACY":1,"LABELING":15,"REMS":6},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA022425","submission_no":30,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-10-23","documents":[{"type":"Letter","date":"2023-10-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022425Orig1s028, s030ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-10-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022425s028s030lbl.pdf","untrusted":true}}],"fact_id":"e36a5139418f0df8d8857390"},{"application":"NDA022425","submission_no":28,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-10-23","documents":[{"type":"Letter","date":"2023-10-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022425Orig1s028, s030ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-10-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022425s028s030lbl.pdf","untrusted":true}}],"fact_id":"752faf8327c58b49db662c32"},{"application":"NDA022425","submission_no":29,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-11-16","documents":[{"type":"Letter","date":"2020-11-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022425Orig1s029ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-11-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022425s029lbl.pdf","untrusted":true}}],"fact_id":"696af16b5fd34400fe5a1370"},{"application":"NDA022425","submission_no":27,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2016-02-12","documents":[{"type":"Letter","date":"2016-02-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022425Orig1s027ltr.pdf","untrusted":true}}],"fact_id":"b64ee7b5143973811a5cb28f"},{"application":"NDA022425","submission_no":25,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2014-03-31","documents":[{"type":"Letter","date":"2014-04-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022425Orig1s025ltr.pdf","untrusted":true}},{"type":"Label","date":"2014-06-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022425s025lbl.pdf","untrusted":true}}],"fact_id":"97555036ee9f4b30afa221cd"}],"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":{"AB":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":"NDA022425","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"MULTAQ","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 400MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Dronedarone HCl","untrusted":true},"brand":{"text":"Multaq","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":342150557.68,"claims":329149,"beneficiaries":67100,"average_spending_per_claim_usd":1039.5005231,"fact_id":"4d43e8c26d855c49554719fa"},{"year":2021,"gross_spending_usd":356717638.11,"claims":317709,"beneficiaries":69274,"average_spending_per_claim_usd":1122.7810295,"fact_id":"7b19aa0ab493b222201b22fa"},{"year":2022,"gross_spending_usd":386678238.99,"claims":312584,"beneficiaries":70837,"average_spending_per_claim_usd":1237.037849,"fact_id":"5e591f46d005deafae6eb883"},{"year":2023,"gross_spending_usd":409348467.91,"claims":310873,"beneficiaries":71895,"average_spending_per_claim_usd":1316.7707325,"fact_id":"15b9b931b4c93638c22d5ad4"},{"year":2024,"gross_spending_usd":414751255.09,"claims":318776,"beneficiaries":72761,"average_spending_per_claim_usd":1301.0742813,"fact_id":"9039b485c34742701723d618"}],"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}}},"rems":{"programs":[{"application":"NDA022425","program":{"text":"Multaq","untrusted":true},"rems_id":"36","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":false,"program_date":"2009-07-01","last_modified":"2016-02-12","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=36","other_programs":0,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"9c692e07b6b21b044d5abdb5"}],"reading":"what the FDA REMS@FDA files tie to the application on the read date; it does not say which prescribers or pharmacies take part or whether a patient needs the program"},"medicaid_state_utilization":{"year":2025,"states_with_data":1,"all_states_medicaid_reimbursed_usd":40545.53,"all_states_medicaid_paid_prescriptions":65,"top_states":[{"state":"KS","medicaid_paid_prescriptions":65,"medicaid_reimbursed_usd":40545.53,"total_reimbursed_usd":40545.53,"packages":1,"covers":"all_record_types","fact_id":"607c181a892ee399f022b378"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":33,"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":"e87208655922948c849456b1","field":"ndc.listing","entity":"ndc:00024414200"},{"fact_id":"b33c5bb784920c884c15f524","field":"ndc.listing","entity":"ndc:00024414206"},{"fact_id":"2442b7ae7894958773ce1c15","field":"ndc.listing","entity":"ndc:00024414260"},{"fact_id":"db9d1da9025cf6ee63d865ea","field":"drug.generic_entry_earliest","entity":"application:NDA022425"},{"fact_id":"c22b227693a9c3562b07dceb","field":"drug.patent","entity":"application:NDA022425"},{"fact_id":"e36a5139418f0df8d8857390","field":"drug.label_event","entity":"application:NDA022425"},{"fact_id":"752faf8327c58b49db662c32","field":"drug.label_event","entity":"application:NDA022425"},{"fact_id":"696af16b5fd34400fe5a1370","field":"drug.label_event","entity":"application:NDA022425"},{"fact_id":"b64ee7b5143973811a5cb28f","field":"drug.label_event","entity":"application:NDA022425"},{"fact_id":"97555036ee9f4b30afa221cd","field":"drug.label_event","entity":"application:NDA022425"},{"fact_id":"be4ef7517f7f5bad440815b7","field":"drug.te_code","entity":"application:NDA022425"},{"fact_id":"8d75e84d445655e56e51bc28","field":"drug.marketing_status","entity":"application:NDA022425"},{"fact_id":"4d43e8c26d855c49554719fa","field":"drug.partd_spending","entity":"drug:dronedarone-hcl|multaq"},{"fact_id":"7b19aa0ab493b222201b22fa","field":"drug.partd_spending","entity":"drug:dronedarone-hcl|multaq"},{"fact_id":"5e591f46d005deafae6eb883","field":"drug.partd_spending","entity":"drug:dronedarone-hcl|multaq"},{"fact_id":"15b9b931b4c93638c22d5ad4","field":"drug.partd_spending","entity":"drug:dronedarone-hcl|multaq"},{"fact_id":"9039b485c34742701723d618","field":"drug.partd_spending","entity":"drug:dronedarone-hcl|multaq"},{"fact_id":"9c692e07b6b21b044d5abdb5","field":"drug.rems","entity":"application:NDA022425"},{"fact_id":"607c181a892ee399f022b378","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00024414260:KS"}],"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":"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."}