{"answer":{"query":"Stiolto Respimat","resolved_as":"applications","packages":3,"applications":["NDA206756"],"identity":{"application_numbers":["NDA206756"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SPRAY, METERED","untrusted":true}],"marketing_start":{"earliest":"2015-05-21","latest":"2019-03-22","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA206756","date":"2030-10-16","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":"8733341","productNo":"001"},"latest_patent_expiry":"2030-10-16","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":7,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":5,"exclusivities_listed":0,"fact_id":"af425dcb846d2283cf544c98"}],"label_history":{"events_total":6,"non_cmc_events":6,"counts_by_class":{"LABELING":4,"EFFICACY":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA206756","submission_no":36,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-12-30","documents":[{"type":"Label","date":"2025-01-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206756Orig1s036lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-01-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/206756Orig1s036ltr.pdf","untrusted":true}}],"fact_id":"a89f0d03dec0791b591b379f"},{"application":"NDA206756","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-05-29","documents":[{"type":"Label","date":"2019-05-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206756s011lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-06-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206756Orig1s011ltr.pdf","untrusted":true}}],"fact_id":"76462d922b569cbc724639b7"},{"application":"NDA206756","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2018-10-05","documents":[{"type":"Label","date":"2018-10-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206756s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-10-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206756Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"c88e5e8de0ed40eeb4d7740d"},{"application":"NDA206756","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-06-09","documents":[{"type":"Letter","date":"2016-06-10","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206756Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2016-06-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s006lbl.pdf","untrusted":true}}],"fact_id":"7ce82bedfaa7e9a9ba9b60d7"},{"application":"NDA206756","submission_no":2,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2016-03-18","documents":[{"type":"Label","date":"2016-03-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206756s002lbl.pdf","untrusted":true}},{"type":"Letter","date":"2016-03-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206756Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"5cb1d099ac71a1d11ac1babd"}],"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":"NDA206756","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"STIOLTO RESPIMAT","untrusted":true},"form":{"text":"SPRAY, METERED;INHALATION","untrusted":true},"strength":{"text":"EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Boehringer Ingelheim Cares Foundation","untrusted":true},"type":"manufacturer","url":"https://www.boehringer-ingelheim.com/us/boehringer-ingelheim-cares-foundation","status":{"state":"limited","effective":"2026-10-15","applies_to":null,"detail":{"text":"No new patient enrollments for individuals with Medicare Part D or Medicare Advantage prescription drug coverage for Boehringer Ingelheim primary care products (Combivent Respimat, Glyxambi, Jardiance, Jentadueto, Jentadueto XR, Spiriva Respimat, Stiolto Respimat, Synjardy, Synjardy XR, Tradjenta, Trijardy XR). Part D patients actively enrolled as of 2026-10-15 continue through their current enrollment period and may be eligible in 2027 only after annual re-enrollment. Product removals: Cyltezo 2026-07-15; OFEV 2026-09-11 (active patients continue through the end of their enrollment or 2027-12-31); no new enrollments for Aptivus, Atrovent and Striverdi from 2026-10-15.","untrusted":true},"read_on":"2026-11-06T12:00:00.000Z","source_url":"https://www.boehringer-ingelheim.com/us/about-us/sustainable-development/our-commitment/pdf/pap-important-updates","proof_state":"eyes_checked"},"needs_status_check":true,"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":"Tiotropium Br/Olodaterol HCl","untrusted":true},"brand":{"text":"Stiolto Respimat","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":264984002.88,"claims":473696,"beneficiaries":106742,"average_spending_per_claim_usd":559.39674998,"fact_id":"ea4442d0746dd8e506f68707"},{"year":2021,"gross_spending_usd":345628077.55,"claims":569048,"beneficiaries":135098,"average_spending_per_claim_usd":607.37947862,"fact_id":"74c960ccbb87fc2a0122a221"},{"year":2022,"gross_spending_usd":387118055.4,"claims":602405,"beneficiaries":142798,"average_spending_per_claim_usd":642.62092015,"fact_id":"0b23bf43b0736a1e8c4823bf"},{"year":2023,"gross_spending_usd":432253137.26,"claims":643950,"beneficiaries":155872,"average_spending_per_claim_usd":671.25263958,"fact_id":"d1959990916e64149f1cb42f"},{"year":2024,"gross_spending_usd":448588557.35,"claims":695441,"beneficiaries":167334,"average_spending_per_claim_usd":645.04186171,"fact_id":"521f53b0960abbe64bf7acc1"}],"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":2024,"states_with_data":51,"all_states_medicaid_reimbursed_usd":69645039.92,"all_states_medicaid_paid_prescriptions":141368,"top_states":[{"state":"CA","medicaid_paid_prescriptions":14424,"medicaid_reimbursed_usd":8078334.63,"total_reimbursed_usd":8143289.93,"packages":2,"covers":"fee_for_service_only","fact_id":"cae55ab59353d5684af02374"},{"state":"OH","medicaid_paid_prescriptions":11698,"medicaid_reimbursed_usd":6076561.14,"total_reimbursed_usd":6118721.79,"packages":1,"covers":"all_record_types","fact_id":"ad4d204818b0f3ca7d01ca0a"},{"state":"KY","medicaid_paid_prescriptions":11268,"medicaid_reimbursed_usd":5088035.88,"total_reimbursed_usd":5088035.88,"packages":1,"covers":"all_record_types","fact_id":"43b1c337c1b26a5e7af9b624"},{"state":"NY","medicaid_paid_prescriptions":6726,"medicaid_reimbursed_usd":3672105.75,"total_reimbursed_usd":3716067.85,"packages":2,"covers":"all_record_types","fact_id":"366aad8f19b5c944d5ec78cd"},{"state":"WA","medicaid_paid_prescriptions":7142,"medicaid_reimbursed_usd":3431617.97,"total_reimbursed_usd":3448819.98,"packages":1,"covers":"all_record_types","fact_id":"f9da1ae8deb3f71620a03d58"},{"state":"PA","medicaid_paid_prescriptions":6726,"medicaid_reimbursed_usd":3308174.82,"total_reimbursed_usd":3339476.05,"packages":1,"covers":"fee_for_service_only","fact_id":"6de20044b7854fee42d9b790"},{"state":"NC","medicaid_paid_prescriptions":5437,"medicaid_reimbursed_usd":2772699.58,"total_reimbursed_usd":2813510.57,"packages":1,"covers":"all_record_types","fact_id":"7e455ecd303af89dba93948a"},{"state":"MI","medicaid_paid_prescriptions":5386,"medicaid_reimbursed_usd":2661923.38,"total_reimbursed_usd":2668876.26,"packages":1,"covers":"all_record_types","fact_id":"800c20c45a82ab75c283c4e2"},{"state":"LA","medicaid_paid_prescriptions":5348,"medicaid_reimbursed_usd":2443499.88,"total_reimbursed_usd":2515609.88,"packages":1,"covers":"fee_for_service_only","fact_id":"572ca024adb146d991a82809"},{"state":"VA","medicaid_paid_prescriptions":4630,"medicaid_reimbursed_usd":2301210.51,"total_reimbursed_usd":2308626.26,"packages":1,"covers":"fee_for_service_only","fact_id":"fc81031a4df5348a96c178f2"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":142052,"medicaid_reimbursed_usd":69882302.05,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":55,"facts_fee_for_service_only":14,"older_year_facts_not_used":0,"dataset":"State Drug Utilization Data 2024","read_on":"2026-11-07T23:59:45.983Z","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":"74d75b9f45dde29717a1995e","field":"ndc.listing","entity":"ndc:00597015528"},{"fact_id":"ec4b5f5bd8da5932e51b37cf","field":"ndc.listing","entity":"ndc:00597015561"},{"fact_id":"0d9636296a629811baa0c516","field":"ndc.listing","entity":"ndc:00597015570"},{"fact_id":"af425dcb846d2283cf544c98","field":"drug.generic_entry_earliest","entity":"application:NDA206756"},{"fact_id":"1ccb9828692499cfc5a33b38","field":"drug.patent","entity":"application:NDA206756"},{"fact_id":"a89f0d03dec0791b591b379f","field":"drug.label_event","entity":"application:NDA206756"},{"fact_id":"76462d922b569cbc724639b7","field":"drug.label_event","entity":"application:NDA206756"},{"fact_id":"c88e5e8de0ed40eeb4d7740d","field":"drug.label_event","entity":"application:NDA206756"},{"fact_id":"7ce82bedfaa7e9a9ba9b60d7","field":"drug.label_event","entity":"application:NDA206756"},{"fact_id":"5cb1d099ac71a1d11ac1babd","field":"drug.label_event","entity":"application:NDA206756"},{"fact_id":"e172504f2594d64bef3366eb","field":"drug.marketing_status","entity":"application:NDA206756"},{"fact_id":"68df1ac006fe0604fce257f6","field":"program.status","entity":"program:boehringer-ingelheim-cares"},{"fact_id":"ea4442d0746dd8e506f68707","field":"drug.partd_spending","entity":"drug:tiotropium-br-olodaterol-hcl|stiolto-respimat"},{"fact_id":"74c960ccbb87fc2a0122a221","field":"drug.partd_spending","entity":"drug:tiotropium-br-olodaterol-hcl|stiolto-respimat"},{"fact_id":"0b23bf43b0736a1e8c4823bf","field":"drug.partd_spending","entity":"drug:tiotropium-br-olodaterol-hcl|stiolto-respimat"},{"fact_id":"d1959990916e64149f1cb42f","field":"drug.partd_spending","entity":"drug:tiotropium-br-olodaterol-hcl|stiolto-respimat"},{"fact_id":"521f53b0960abbe64bf7acc1","field":"drug.partd_spending","entity":"drug:tiotropium-br-olodaterol-hcl|stiolto-respimat"},{"fact_id":"cae55ab59353d5684af02374","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597015561:CA"},{"fact_id":"ad4d204818b0f3ca7d01ca0a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597015561:OH"},{"fact_id":"43b1c337c1b26a5e7af9b624","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597015561:KY"},{"fact_id":"366aad8f19b5c944d5ec78cd","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597015561:NY"},{"fact_id":"f9da1ae8deb3f71620a03d58","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597015561:WA"},{"fact_id":"6de20044b7854fee42d9b790","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597015561:PA"},{"fact_id":"7e455ecd303af89dba93948a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597015561:NC"},{"fact_id":"800c20c45a82ab75c283c4e2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597015561:MI"},{"fact_id":"572ca024adb146d991a82809","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597015561:LA"},{"fact_id":"fc81031a4df5348a96c178f2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597015561:VA"}],"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":"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."}