{"answer":{"query":"Arikayce","resolved_as":"applications","packages":1,"applications":["NDA207356"],"identity":{"application_numbers":["NDA207356"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SUSPENSION","untrusted":true}],"marketing_start":{"earliest":"2018-10-12","latest":"2018-10-12","packages_with_a_start_date":1}},"generic_entry":[{"application":"NDA207356","date":"2035-05-15","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":"10251900","productNo":"001"},"latest_patent_expiry":"2035-05-15","latest_exclusivity_expiry":"2030-09-28","dated_barriers":16,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":14,"exclusivities_listed":2,"fact_id":"5554f267e0e288f61a5a975b"}],"label_history":{"events_total":6,"non_cmc_events":6,"counts_by_class":{"LABELING":5,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA207356","submission_no":25,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-25","documents":[{"type":"Letter","date":"2026-06-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/207356Orig1s025ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/207356s025lbl.pdf","untrusted":true}}],"fact_id":"75dad188971c050f64ce1241"},{"application":"NDA207356","submission_no":19,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-12-05","documents":[{"type":"Letter","date":"2025-12-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207356Orig1s019ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-12-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207356s019lbl.pdf","untrusted":true}}],"fact_id":"f241690fce5d32ef1c6809a7"},{"application":"NDA207356","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-06-01","documents":[{"type":"Letter","date":"2023-06-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207356Orig1s013ltr.pdf","untrusted":true}}],"fact_id":"bb89d8ab41f8b638ac997279"},{"application":"NDA207356","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-02-10","documents":[{"type":"Letter","date":"2023-02-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207356Orig1s012ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-02-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207356s012lbl.pdf","untrusted":true}}],"fact_id":"219ee804c468a15ab4225877"},{"application":"NDA207356","submission_no":3,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2020-10-19","documents":[{"type":"Letter","date":"2020-10-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207356Orig1s003ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-06-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207356Orig1s003Lbl.pdf","untrusted":true}}],"fact_id":"b193c8dfa82f1942e7a39865"}],"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":"NDA207356","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ARIKAYCE KIT","untrusted":true},"form":{"text":"SUSPENSION, LIPOSOMAL;INHALATION","untrusted":true},"strength":{"text":"EQ 590MG BASE/8.4ML","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Amikacin Liposomal/Neb.Accessr","untrusted":true},"brand":{"text":"Arikayce","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":98355319.06,"claims":8172,"beneficiaries":1641,"average_spending_per_claim_usd":12035.648441,"fact_id":"29c25e084b72386f2af21958"},{"year":2021,"gross_spending_usd":102789693.85,"claims":8064,"beneficiaries":1730,"average_spending_per_claim_usd":12746.737829,"fact_id":"0cc0daf05ad9945c2c3df0e2"},{"year":2022,"gross_spending_usd":126923540.16,"claims":9160,"beneficiaries":1925,"average_spending_per_claim_usd":13856.281677,"fact_id":"49388718eaf309ece8513c06"},{"year":2023,"gross_spending_usd":161637429.03,"claims":10810,"beneficiaries":2208,"average_spending_per_claim_usd":14952.583629,"fact_id":"8ba40df5491cecf9d8060c0a"},{"year":2024,"gross_spending_usd":187063382.21,"claims":12361,"beneficiaries":2647,"average_spending_per_claim_usd":15133.353467,"fact_id":"1c3eb40e4989e52a798b4a36"}],"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}}},"medicaid_state_utilization":{"year":2025,"states_with_data":1,"all_states_medicaid_reimbursed_usd":935047.52,"all_states_medicaid_paid_prescriptions":60,"top_states":[{"state":"TX","medicaid_paid_prescriptions":60,"medicaid_reimbursed_usd":935047.52,"total_reimbursed_usd":935047.52,"packages":1,"covers":"all_record_types","fact_id":"97e4da150aa81093801c50a0"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":5,"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":"fa11094b7c39e6cd08be81e3","field":"ndc.listing","entity":"ndc:71558059028"},{"fact_id":"5554f267e0e288f61a5a975b","field":"drug.generic_entry_earliest","entity":"application:NDA207356"},{"fact_id":"66dedb106251836bac794c0c","field":"drug.patent","entity":"application:NDA207356"},{"fact_id":"bf0af257e71db9acc7b34cca","field":"drug.exclusivity","entity":"application:NDA207356"},{"fact_id":"75dad188971c050f64ce1241","field":"drug.label_event","entity":"application:NDA207356"},{"fact_id":"f241690fce5d32ef1c6809a7","field":"drug.label_event","entity":"application:NDA207356"},{"fact_id":"bb89d8ab41f8b638ac997279","field":"drug.label_event","entity":"application:NDA207356"},{"fact_id":"219ee804c468a15ab4225877","field":"drug.label_event","entity":"application:NDA207356"},{"fact_id":"b193c8dfa82f1942e7a39865","field":"drug.label_event","entity":"application:NDA207356"},{"fact_id":"a484b1a2e14aa88a4339b213","field":"drug.marketing_status","entity":"application:NDA207356"},{"fact_id":"29c25e084b72386f2af21958","field":"drug.partd_spending","entity":"drug:amikacin-liposomal-neb-accessr|arikayce"},{"fact_id":"0cc0daf05ad9945c2c3df0e2","field":"drug.partd_spending","entity":"drug:amikacin-liposomal-neb-accessr|arikayce"},{"fact_id":"49388718eaf309ece8513c06","field":"drug.partd_spending","entity":"drug:amikacin-liposomal-neb-accessr|arikayce"},{"fact_id":"8ba40df5491cecf9d8060c0a","field":"drug.partd_spending","entity":"drug:amikacin-liposomal-neb-accessr|arikayce"},{"fact_id":"1c3eb40e4989e52a798b4a36","field":"drug.partd_spending","entity":"drug:amikacin-liposomal-neb-accessr|arikayce"},{"fact_id":"97e4da150aa81093801c50a0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:71558059028:TX"}],"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":"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."}