{"answer":{"query":"Spiriva Respimat","resolved_as":"applications","packages":5,"applications":["NDA021936","NDA207070"],"identity":{"application_numbers":["NDA021936","NDA207070"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SPRAY, METERED","untrusted":true}],"marketing_start":{"earliest":"2014-09-30","latest":"2019-03-15","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA021936","date":"2031-04-16","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*PED","productNo":"001"},"latest_patent_expiry":"2031-04-16","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":8,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":0,"fact_id":"203be4104a04f1ca0a1f2d42"}],"label_history":{"events_total":5,"non_cmc_events":5,"counts_by_class":{"LABELING":4,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA021936","submission_no":36,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-12-27","documents":[{"type":"Letter","date":"2024-12-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021936Orig1s036ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-01-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021936Orig1s036lbl.pdf","untrusted":true}}],"fact_id":"feaf01ae77a03b89afed056e"},{"application":"NDA021936","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-02-14","documents":[{"type":"Label","date":"2019-02-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021936s012lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-02-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021936Orig1s012ltr.pdf","untrusted":true}}],"fact_id":"782c3402ca0faf4724a30457"},{"application":"NDA021936","submission_no":7,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2017-02-15","documents":[{"type":"Label","date":"2017-02-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021936s007lbl.pdf","untrusted":true}}],"fact_id":"5ebe49f6a329b9807478e929"},{"application":"NDA021936","submission_no":5,"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/2016/021936Orig1s005ltr.pdf","untrusted":true}},{"type":"Label","date":"2016-06-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021936s005lbl.pdf","untrusted":true}}],"fact_id":"fd08c37bf4c9160f65ee1761"},{"application":"NDA021936","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-01-15","documents":[{"type":"Letter","date":"2016-01-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021936Orig1s003ltr.pdf","untrusted":true}},{"type":"Label","date":"2016-02-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021936s003lbl.pdf","untrusted":true}}],"fact_id":"49762fbe0a0aae48bc730486"}],"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":"NDA021936","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SPIRIVA RESPIMAT","untrusted":true},"form":{"text":"SPRAY, METERED;INHALATION","untrusted":true},"strength":{"text":"EQ 0.00125MG BASE/INH","untrusted":true}},{"application":"NDA021936","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SPIRIVA RESPIMAT","untrusted":true},"form":{"text":"SPRAY, METERED;INHALATION","untrusted":true},"strength":{"text":"EQ 0.0025MG BASE/INH","untrusted":true}},{"application":"NDA207070","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SPIRIVA RESPIMAT","untrusted":true},"form":{"text":"SPRAY;INHALATION","untrusted":true},"strength":{"text":"2.5MCG","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 Bromide","untrusted":true},"brand":{"text":"Spiriva Respimat","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":804565194.21,"claims":1361758,"beneficiaries":326120,"average_spending_per_claim_usd":590.82832207,"fact_id":"c7fcc00b44db5ce75eb683c5"},{"year":2021,"gross_spending_usd":856830826,"claims":1346973,"beneficiaries":331447,"average_spending_per_claim_usd":636.11581375,"fact_id":"b678b66a2cf177fcf00fa129"},{"year":2022,"gross_spending_usd":891532179.06,"claims":1325200,"beneficiaries":329659,"average_spending_per_claim_usd":672.75292715,"fact_id":"109002e2609b010b422fdf14"},{"year":2023,"gross_spending_usd":923556171.13,"claims":1313138,"beneficiaries":333929,"average_spending_per_claim_usd":703.31996419,"fact_id":"a1aae0bb13c2d0697d46eb36"},{"year":2024,"gross_spending_usd":877208066.09,"claims":1276042,"beneficiaries":327575,"average_spending_per_claim_usd":687.44450895,"fact_id":"74159c47b48ce64f1ebc0952"}],"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":3482.24,"all_states_medicaid_paid_prescriptions":506,"top_states":[{"state":"KY","medicaid_paid_prescriptions":506,"medicaid_reimbursed_usd":3482.24,"total_reimbursed_usd":3482.24,"packages":1,"covers":"fee_for_service_only","fact_id":"1f5e78d1ac96ecfbb56ea186"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":1,"older_year_facts_not_used":111,"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":"1059ea9f91aeb33ec4631b67","field":"ndc.listing","entity":"ndc:00597010028"},{"fact_id":"e1fec3223a4435da608a133e","field":"ndc.listing","entity":"ndc:00597010051"},{"fact_id":"23d19f9d61416a32afa0a220","field":"ndc.listing","entity":"ndc:00597010061"},{"fact_id":"203be4104a04f1ca0a1f2d42","field":"drug.generic_entry_earliest","entity":"application:NDA021936"},{"fact_id":"a2ded0e626aa79ccdf0c9712","field":"drug.patent","entity":"application:NDA021936"},{"fact_id":"feaf01ae77a03b89afed056e","field":"drug.label_event","entity":"application:NDA021936"},{"fact_id":"782c3402ca0faf4724a30457","field":"drug.label_event","entity":"application:NDA021936"},{"fact_id":"5ebe49f6a329b9807478e929","field":"drug.label_event","entity":"application:NDA021936"},{"fact_id":"fd08c37bf4c9160f65ee1761","field":"drug.label_event","entity":"application:NDA021936"},{"fact_id":"49762fbe0a0aae48bc730486","field":"drug.label_event","entity":"application:NDA021936"},{"fact_id":"432c7675ce31e62e122e0d8c","field":"drug.marketing_status","entity":"application:NDA021936"},{"fact_id":"095897d606a2765c65b60311","field":"drug.marketing_status","entity":"application:NDA021936"},{"fact_id":"b1e2b38feeb203d770fcddc5","field":"drug.marketing_status","entity":"application:NDA207070"},{"fact_id":"68df1ac006fe0604fce257f6","field":"program.status","entity":"program:boehringer-ingelheim-cares"},{"fact_id":"c7fcc00b44db5ce75eb683c5","field":"drug.partd_spending","entity":"drug:tiotropium-bromide|spiriva-respimat"},{"fact_id":"b678b66a2cf177fcf00fa129","field":"drug.partd_spending","entity":"drug:tiotropium-bromide|spiriva-respimat"},{"fact_id":"109002e2609b010b422fdf14","field":"drug.partd_spending","entity":"drug:tiotropium-bromide|spiriva-respimat"},{"fact_id":"a1aae0bb13c2d0697d46eb36","field":"drug.partd_spending","entity":"drug:tiotropium-bromide|spiriva-respimat"},{"fact_id":"74159c47b48ce64f1ebc0952","field":"drug.partd_spending","entity":"drug:tiotropium-bromide|spiriva-respimat"},{"fact_id":"1f5e78d1ac96ecfbb56ea186","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597010051:KY"}],"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":"generic_entry:NDA207070","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"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."}