{"answer":{"query":"Arnuity Ellipta","resolved_as":"applications","packages":8,"applications":["NDA205625"],"identity":{"application_numbers":["NDA205625"],"marketing_categories":["NDA","NDA AUTHORIZED GENERIC"],"labelers":[],"dosage_forms":[{"text":"POWDER","untrusted":true}],"marketing_start":{"earliest":"2014-08-20","latest":"2025-07-21","packages_with_a_start_date":8}},"generic_entry":[{"application":"NDA205625","date":"2026-03-01","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":"exclusivity","ref":"M-290","productNo":"003"},"latest_patent_expiry":"NOT_PROVIDED","latest_exclusivity_expiry":"2026-03-01","dated_barriers":1,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":0,"exclusivities_listed":1,"fact_id":"21de00728027e01f34ed607b"}],"label_history":{"events_total":5,"non_cmc_events":5,"counts_by_class":{"LABELING":3,"EFFICACY":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA205625","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-10-18","documents":[{"type":"Letter","date":"2023-10-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205625Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-10-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205625s011lbl.pdf","untrusted":true}}],"fact_id":"bf323f13cfd2e4bb69fbf009"},{"application":"NDA205625","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-03-01","documents":[{"type":"Letter","date":"2023-03-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205625Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-03-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205625s009lbl.pdf","untrusted":true}}],"fact_id":"2ee81db3b5ee55a98c6146ba"},{"application":"NDA205625","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-01-07","documents":[{"type":"Label","date":"2019-01-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205625s007lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-02-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205625Orig1s007ltr.pdf","untrusted":true}}],"fact_id":"d7ea777666b7a88f75f77131"},{"application":"NDA205625","submission_no":5,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2018-05-17","documents":[{"type":"Label","date":"2018-05-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205625s005lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-05-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205625Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"e3828f7454c626c16b03ce9e"},{"application":"NDA205625","submission_no":1,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2015-03-20","documents":[{"type":"Letter","date":"2015-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205625Orig1s001ltr.pdf","untrusted":true}},{"type":"Label","date":"2015-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205625Orig1s001Lbl.pdf","untrusted":true}}],"fact_id":"ce421ad611120f1d0ba45940"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"NOT_PROVIDED":3},"marketing_status_counts":{"Prescription":3},"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":"NDA205625","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ARNUITY ELLIPTA","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.2MG/INH","untrusted":true}},{"application":"NDA205625","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ARNUITY ELLIPTA","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.05MG/INH","untrusted":true}},{"application":"NDA205625","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ARNUITY ELLIPTA","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"0.1MG/INH","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":8,"most_recent":[{"recall_number":"D-0480-2021","classification":"Class II","status":"Terminated","report_date":"2021-06-02","recall_initiated":"2021-03-15","recalling_firm":{"text":"Cardinal Health Inc.","untrusted":true},"reason":{"text":"CGMP Deviations: Intermittent exposure to temperature excursion during storage.","untrusted":true},"packages_named":5,"fact_id":"fa1528be4e8606514d0350f8"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"GSK Patient Assistance Program","untrusted":true},"type":"manufacturer","url":"https://www.gskpaf.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."},"spending":{"reported_under":{"generic":{"text":"Fluticasone Furoate","untrusted":true},"brand":{"text":"Arnuity Ellipta","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":80943847,"claims":301437,"beneficiaries":69403,"average_spending_per_claim_usd":268.52658101,"fact_id":"f9dd147928b56d521363c625"},{"year":2021,"gross_spending_usd":85013030.59,"claims":295772,"beneficiaries":68816,"average_spending_per_claim_usd":287.42758135,"fact_id":"e9d2b195e4315f744c2ad730"},{"year":2022,"gross_spending_usd":88815140.17,"claims":285882,"beneficiaries":67936,"average_spending_per_claim_usd":310.67062694,"fact_id":"061f0b3502480c03a22ef239"},{"year":2023,"gross_spending_usd":98260735.31,"claims":289514,"beneficiaries":74815,"average_spending_per_claim_usd":339.39890751,"fact_id":"5bb53eb8eeed764abaf5a372"},{"year":2024,"gross_spending_usd":199856122.56,"claims":659581,"beneficiaries":181821,"average_spending_per_claim_usd":303.00466896,"fact_id":"6c74f8c5c579fda5817feaf4"}],"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":12,"all_states_medicaid_reimbursed_usd":2375341.16,"all_states_medicaid_paid_prescriptions":9975,"top_states":[{"state":"WV","medicaid_paid_prescriptions":3969,"medicaid_reimbursed_usd":1002299.11,"total_reimbursed_usd":1016891.05,"packages":3,"covers":"all_record_types","fact_id":"9eb203dcc02cfd18843d7668"},{"state":"AR","medicaid_paid_prescriptions":3438,"medicaid_reimbursed_usd":769089.42,"total_reimbursed_usd":782306.37,"packages":3,"covers":"fee_for_service_only","fact_id":"3e2d3167c48f1d6066f45a1f"},{"state":"FL","medicaid_paid_prescriptions":647,"medicaid_reimbursed_usd":156566.87,"total_reimbursed_usd":159372.76,"packages":2,"covers":"fee_for_service_only","fact_id":"b219c49e8d3cff5381479d76"},{"state":"MI","medicaid_paid_prescriptions":507,"medicaid_reimbursed_usd":132630.53,"total_reimbursed_usd":139443.72,"packages":2,"covers":"fee_for_service_only","fact_id":"02720d7e3253da43aba7d82b"},{"state":"MT","medicaid_paid_prescriptions":380,"medicaid_reimbursed_usd":89935.91,"total_reimbursed_usd":90225.63,"packages":2,"covers":"all_record_types","fact_id":"da58273ed776b96a6bdd11e1"},{"state":"OK","medicaid_paid_prescriptions":259,"medicaid_reimbursed_usd":60470.2,"total_reimbursed_usd":63654.95,"packages":2,"covers":"fee_for_service_only","fact_id":"44b10cd6a1b43b4b3426a400"},{"state":"MN","medicaid_paid_prescriptions":236,"medicaid_reimbursed_usd":41682.9,"total_reimbursed_usd":41682.9,"packages":1,"covers":"all_record_types","fact_id":"078c62a19b2a77e119655b23"},{"state":"NE","medicaid_paid_prescriptions":126,"medicaid_reimbursed_usd":32767.27,"total_reimbursed_usd":32767.27,"packages":1,"covers":"all_record_types","fact_id":"7d9acc3c14b2ea1170bb3fc8"},{"state":"NC","medicaid_paid_prescriptions":127,"medicaid_reimbursed_usd":27504.81,"total_reimbursed_usd":29017.82,"packages":1,"covers":"fee_for_service_only","fact_id":"17094c16799e8087038a255f"},{"state":"CT","medicaid_paid_prescriptions":100,"medicaid_reimbursed_usd":21229.93,"total_reimbursed_usd":21991.55,"packages":1,"covers":"all_record_types","fact_id":"8ce3e514964401aac0795d58"}],"unlabelled_state_code_xx":null,"built_from_facts":20,"facts_fee_for_service_only":7,"older_year_facts_not_used":119,"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":"917928d57fd794b88451cd88","field":"ndc.listing","entity":"ndc:00173087410"},{"fact_id":"302dc1e44ae35260f401893b","field":"ndc.listing","entity":"ndc:00173087414"},{"fact_id":"af11cec3eae384c99c9173ef","field":"ndc.listing","entity":"ndc:00173087610"},{"fact_id":"21de00728027e01f34ed607b","field":"drug.generic_entry_earliest","entity":"application:NDA205625"},{"fact_id":"b943ce884facedbed597dfc4","field":"drug.exclusivity","entity":"application:NDA205625"},{"fact_id":"bf323f13cfd2e4bb69fbf009","field":"drug.label_event","entity":"application:NDA205625"},{"fact_id":"2ee81db3b5ee55a98c6146ba","field":"drug.label_event","entity":"application:NDA205625"},{"fact_id":"d7ea777666b7a88f75f77131","field":"drug.label_event","entity":"application:NDA205625"},{"fact_id":"e3828f7454c626c16b03ce9e","field":"drug.label_event","entity":"application:NDA205625"},{"fact_id":"ce421ad611120f1d0ba45940","field":"drug.label_event","entity":"application:NDA205625"},{"fact_id":"dfe128d0fe5f700805552852","field":"drug.marketing_status","entity":"application:NDA205625"},{"fact_id":"a18400bb2858fdfb0abd1ba1","field":"drug.marketing_status","entity":"application:NDA205625"},{"fact_id":"37aa2f3f056586c65875a6d4","field":"drug.marketing_status","entity":"application:NDA205625"},{"fact_id":"fa1528be4e8606514d0350f8","field":"ndc.recall","entity":"ndc:00173087610"},{"fact_id":"f9dd147928b56d521363c625","field":"drug.partd_spending","entity":"drug:fluticasone-furoate|arnuity-ellipta"},{"fact_id":"e9d2b195e4315f744c2ad730","field":"drug.partd_spending","entity":"drug:fluticasone-furoate|arnuity-ellipta"},{"fact_id":"061f0b3502480c03a22ef239","field":"drug.partd_spending","entity":"drug:fluticasone-furoate|arnuity-ellipta"},{"fact_id":"5bb53eb8eeed764abaf5a372","field":"drug.partd_spending","entity":"drug:fluticasone-furoate|arnuity-ellipta"},{"fact_id":"6c74f8c5c579fda5817feaf4","field":"drug.partd_spending","entity":"drug:fluticasone-furoate|arnuity-ellipta"},{"fact_id":"9eb203dcc02cfd18843d7668","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173087410:WV"},{"fact_id":"3e2d3167c48f1d6066f45a1f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173087410:AR"},{"fact_id":"b219c49e8d3cff5381479d76","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173087610:FL"},{"fact_id":"02720d7e3253da43aba7d82b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173087610:MI"},{"fact_id":"da58273ed776b96a6bdd11e1","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173087410:MT"},{"fact_id":"44b10cd6a1b43b4b3426a400","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173087610:OK"},{"fact_id":"078c62a19b2a77e119655b23","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173088810:MN"},{"fact_id":"7d9acc3c14b2ea1170bb3fc8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173087610:NE"},{"fact_id":"17094c16799e8087038a255f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173088810:NC"},{"fact_id":"8ce3e514964401aac0795d58","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173088810:CT"}],"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":"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":"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."}