{"answer":{"query":"Incruse Ellipta","resolved_as":"applications","packages":3,"applications":["NDA205382"],"identity":{"application_numbers":["NDA205382"],"marketing_categories":["NDA","NDA AUTHORIZED GENERIC"],"labelers":[],"dosage_forms":[{"text":"AEROSOL, POWDER","untrusted":true}],"marketing_start":{"earliest":"2014-04-30","latest":"2026-04-06","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA205382","date":"2027-12-18","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":"7488827","productNo":"001"},"latest_patent_expiry":"2027-12-18","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":1,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":0,"fact_id":"e9a6812191247d51ceaeace6"}],"label_history":{"events_total":5,"non_cmc_events":5,"counts_by_class":{"LABELING":3,"EFFICACY":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA205382","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-12-13","documents":[{"type":"Letter","date":"2023-12-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/205382Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-12-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205382s013lbl.pdf","untrusted":true}}],"fact_id":"0a5edf53556eabb3db557cf9"},{"application":"NDA205382","submission_no":10,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-06-06","documents":[{"type":"Letter","date":"2019-06-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/205382Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2019-06-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/205382s010lbl.pdf","untrusted":true}}],"fact_id":"3f51a834c9704e2de6bb8fe1"},{"application":"NDA205382","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-10-20","documents":[{"type":"Letter","date":"2017-10-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205382Orig1s008ltr.pdf","untrusted":true}},{"type":"Label","date":"2017-10-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205382s008lbl.pdf","untrusted":true}}],"fact_id":"76536867ea0580bd93e159ae"},{"application":"NDA205382","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-06-13","documents":[{"type":"Label","date":"2017-06-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205382s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-06-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205382Orig1s006ltr.pdf","untrusted":true}}],"fact_id":"06b865d5b18793ee07ec6c7b"},{"application":"NDA205382","submission_no":2,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2016-02-24","documents":[{"type":"Label","date":"2016-02-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205382s002lbl.pdf","untrusted":true}},{"type":"Letter","date":"2016-02-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205382Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"20407faf4c602183ddcc1792"}],"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":"NDA205382","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"INCRUSE ELLIPTA","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"EQ 0.0625MG BASE/INH","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Umeclidinium Bromide","untrusted":true},"brand":{"text":"Incruse Ellipta","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":605138195.44,"claims":1372688,"beneficiaries":270800,"average_spending_per_claim_usd":440.84176116,"fact_id":"eacf5fffdbdbd8ce7fc0178c"},{"year":2021,"gross_spending_usd":555719848.14,"claims":1195709,"beneficiaries":244695,"average_spending_per_claim_usd":464.76178413,"fact_id":"3cd3152c99425dee623109b8"},{"year":2022,"gross_spending_usd":498890588.95,"claims":1051785,"beneficiaries":214355,"average_spending_per_claim_usd":474.32753742,"fact_id":"f521799de33dd923f2602919"},{"year":2023,"gross_spending_usd":456391929.41,"claims":949429,"beneficiaries":201618,"average_spending_per_claim_usd":480.70148417,"fact_id":"a530f7c2fe9d243648b6f637"},{"year":2024,"gross_spending_usd":375858547.52,"claims":852329,"beneficiaries":185597,"average_spending_per_claim_usd":440.9782461,"fact_id":"12316f5f15bfc0f53eb2f726"}],"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":3,"all_states_medicaid_reimbursed_usd":196607.36,"all_states_medicaid_paid_prescriptions":631,"top_states":[{"state":"NH","medicaid_paid_prescriptions":415,"medicaid_reimbursed_usd":162334.55,"total_reimbursed_usd":162334.55,"packages":1,"covers":"fee_for_service_only","fact_id":"46557144d59e3b7c95c436e3"},{"state":"MT","medicaid_paid_prescriptions":64,"medicaid_reimbursed_usd":22554.37,"total_reimbursed_usd":22554.37,"packages":1,"covers":"all_record_types","fact_id":"411347a8f4e730d5bd40b2b2"},{"state":"IN","medicaid_paid_prescriptions":152,"medicaid_reimbursed_usd":11718.44,"total_reimbursed_usd":11718.44,"packages":1,"covers":"fee_for_service_only","fact_id":"fb2c4c2e7aab68f6b0f37110"}],"unlabelled_state_code_xx":null,"built_from_facts":3,"facts_fee_for_service_only":2,"older_year_facts_not_used":59,"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":"98a466fe958e818587b0241f","field":"ndc.listing","entity":"ndc:00173087306"},{"fact_id":"5e0c8488792606886e147558","field":"ndc.listing","entity":"ndc:00173087310"},{"fact_id":"78ac97bde4055b87f3493de9","field":"ndc.listing","entity":"ndc:66993018997"},{"fact_id":"e9a6812191247d51ceaeace6","field":"drug.generic_entry_earliest","entity":"application:NDA205382"},{"fact_id":"1a57af17f025746ef8012271","field":"drug.patent","entity":"application:NDA205382"},{"fact_id":"0a5edf53556eabb3db557cf9","field":"drug.label_event","entity":"application:NDA205382"},{"fact_id":"3f51a834c9704e2de6bb8fe1","field":"drug.label_event","entity":"application:NDA205382"},{"fact_id":"76536867ea0580bd93e159ae","field":"drug.label_event","entity":"application:NDA205382"},{"fact_id":"06b865d5b18793ee07ec6c7b","field":"drug.label_event","entity":"application:NDA205382"},{"fact_id":"20407faf4c602183ddcc1792","field":"drug.label_event","entity":"application:NDA205382"},{"fact_id":"08f03e7152831ef20e8f04e9","field":"drug.marketing_status","entity":"application:NDA205382"},{"fact_id":"eacf5fffdbdbd8ce7fc0178c","field":"drug.partd_spending","entity":"drug:umeclidinium-bromide|incruse-ellipta"},{"fact_id":"3cd3152c99425dee623109b8","field":"drug.partd_spending","entity":"drug:umeclidinium-bromide|incruse-ellipta"},{"fact_id":"f521799de33dd923f2602919","field":"drug.partd_spending","entity":"drug:umeclidinium-bromide|incruse-ellipta"},{"fact_id":"a530f7c2fe9d243648b6f637","field":"drug.partd_spending","entity":"drug:umeclidinium-bromide|incruse-ellipta"},{"fact_id":"12316f5f15bfc0f53eb2f726","field":"drug.partd_spending","entity":"drug:umeclidinium-bromide|incruse-ellipta"},{"fact_id":"46557144d59e3b7c95c436e3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173087310:NH"},{"fact_id":"411347a8f4e730d5bd40b2b2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173087310:MT"},{"fact_id":"fb2c4c2e7aab68f6b0f37110","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00173087306:IN"}],"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."}