{"answer":{"query":"Spiriva Handihaler","resolved_as":"applications","packages":5,"applications":["NDA021395"],"identity":{"application_numbers":["NDA021395"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2005-10-11","latest":"2025-08-29","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA021395","date":"2026-07-19","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":"8022082*PED","productNo":"001"},"latest_patent_expiry":"2026-07-19","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":2,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":0,"fact_id":"b577ca2963d8f9ccb955a23b"}],"label_history":{"events_total":19,"non_cmc_events":14,"counts_by_class":{"LABELING":13,"EFFICACY":1},"cmc_events":5,"recent_non_cmc_events":[{"application":"NDA021395","submission_no":78,"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/2025/021395Orig1s078lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-01-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021395Orig1s078ltr.pdf","untrusted":true}}],"fact_id":"610901382e916c6839146015"},{"application":"NDA021395","submission_no":48,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-02-01","documents":[{"type":"Label","date":"2018-02-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021395s048lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-02-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021395Orig1s048ltr.pdf","untrusted":true}}],"fact_id":"6a154081b655842ee4cf5b96"},{"application":"NDA021395","submission_no":44,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-06-23","documents":[{"type":"Letter","date":"2016-06-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021395Orig1s044ltr.pdf","untrusted":true}}],"fact_id":"e63c164327b16104671ede47"},{"application":"NDA021395","submission_no":40,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2015-12-10","documents":[{"type":"Letter","date":"2015-12-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021395Orig1s040ltr.pdf","untrusted":true}},{"type":"Label","date":"2015-12-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021395s040lbl.pdf","untrusted":true}}],"fact_id":"a2633529ff8c1c00920b42b3"},{"application":"NDA021395","submission_no":34,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2011-11-04","documents":[],"fact_id":"4ed85b3e150b01d91d227bd6"}],"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":{"AB":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":"NDA021395","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"SPIRIVA","untrusted":true},"form":{"text":"POWDER;INHALATION","untrusted":true},"strength":{"text":"EQ 0.018MG BASE/INH","untrusted":true}}]},"recalls":{"recalls_total":5,"counts_by_class":{"Class II":3,"Class III":2},"packages_of_these_applications":5,"most_recent":[{"recall_number":"D-0197-2024","classification":"Class II","status":"Terminated","report_date":"2024-01-03","recall_initiated":"2022-01-26","recalling_firm":{"text":"CARDINAL HEALTHCARE","untrusted":true},"reason":{"text":"CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.","untrusted":true},"packages_named":3,"fact_id":"d088143f339d3578a47e7fe2"},{"recall_number":"D-0453-2021","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":3,"fact_id":"642bbb40525097c789e185ec"},{"recall_number":"D-0242-2018","classification":"Class II","status":"Terminated","report_date":"2018-02-07","recall_initiated":"2017-12-14","recalling_firm":{"text":"Boehringer Ingelheim Pharmaceuticals, Inc.","untrusted":true},"reason":{"text":"Failed Stability Specifications","untrusted":true},"packages_named":3,"fact_id":"7165be19797e7f1f8492616f"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"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 Handihaler","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":1153453863.4,"claims":1644087,"beneficiaries":371913,"average_spending_per_claim_usd":701.5771449,"fact_id":"8bda193c0f446d4e47a7c9f0"},{"year":2021,"gross_spending_usd":1035920137.6,"claims":1375217,"beneficiaries":323646,"average_spending_per_claim_usd":753.27758282,"fact_id":"b1064d54a7536ffa6074497b"},{"year":2022,"gross_spending_usd":935520426.63,"claims":1181232,"beneficiaries":280582,"average_spending_per_claim_usd":791.98703272,"fact_id":"096cbc12b6c4d3e12a6cc833"},{"year":2023,"gross_spending_usd":782927124.78,"claims":946781,"beneficiaries":236984,"average_spending_per_claim_usd":826.93582231,"fact_id":"044460f0359d413a4d20c478"},{"year":2024,"gross_spending_usd":486261174.8,"claims":619477,"beneficiaries":157377,"average_spending_per_claim_usd":784.95436441,"fact_id":"db9a357bc7c58d2c3af43a79"}],"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":15310.38,"all_states_medicaid_paid_prescriptions":64,"top_states":[{"state":"NV","medicaid_paid_prescriptions":64,"medicaid_reimbursed_usd":15310.38,"total_reimbursed_usd":15310.38,"packages":1,"covers":"all_record_types","fact_id":"94d226a96e8250806183a51f"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":80,"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":"2ed6d29576165440cd025735","field":"ndc.listing","entity":"ndc:00597007541"},{"fact_id":"ae6d95e50319153c9e6584ef","field":"ndc.listing","entity":"ndc:00597007547"},{"fact_id":"d44f0046a5e1f1ad333e1fee","field":"ndc.listing","entity":"ndc:00597007575"},{"fact_id":"b577ca2963d8f9ccb955a23b","field":"drug.generic_entry_earliest","entity":"application:NDA021395"},{"fact_id":"29f454d1a06f4d372fbe8ba8","field":"drug.patent","entity":"application:NDA021395"},{"fact_id":"610901382e916c6839146015","field":"drug.label_event","entity":"application:NDA021395"},{"fact_id":"6a154081b655842ee4cf5b96","field":"drug.label_event","entity":"application:NDA021395"},{"fact_id":"e63c164327b16104671ede47","field":"drug.label_event","entity":"application:NDA021395"},{"fact_id":"a2633529ff8c1c00920b42b3","field":"drug.label_event","entity":"application:NDA021395"},{"fact_id":"4ed85b3e150b01d91d227bd6","field":"drug.label_event","entity":"application:NDA021395"},{"fact_id":"f784fbef73dfd4699099df29","field":"drug.te_code","entity":"application:NDA021395"},{"fact_id":"b2ce1b4ba597cb4765cbdae6","field":"drug.marketing_status","entity":"application:NDA021395"},{"fact_id":"d088143f339d3578a47e7fe2","field":"ndc.recall","entity":"ndc:00597007547"},{"fact_id":"642bbb40525097c789e185ec","field":"ndc.recall","entity":"ndc:00597007547"},{"fact_id":"7165be19797e7f1f8492616f","field":"ndc.recall","entity":"ndc:00597007541"},{"fact_id":"68df1ac006fe0604fce257f6","field":"program.status","entity":"program:boehringer-ingelheim-cares"},{"fact_id":"8bda193c0f446d4e47a7c9f0","field":"drug.partd_spending","entity":"drug:tiotropium-bromide|spiriva-handihaler"},{"fact_id":"b1064d54a7536ffa6074497b","field":"drug.partd_spending","entity":"drug:tiotropium-bromide|spiriva-handihaler"},{"fact_id":"096cbc12b6c4d3e12a6cc833","field":"drug.partd_spending","entity":"drug:tiotropium-bromide|spiriva-handihaler"},{"fact_id":"044460f0359d413a4d20c478","field":"drug.partd_spending","entity":"drug:tiotropium-bromide|spiriva-handihaler"},{"fact_id":"db9a357bc7c58d2c3af43a79","field":"drug.partd_spending","entity":"drug:tiotropium-bromide|spiriva-handihaler"},{"fact_id":"94d226a96e8250806183a51f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597007575:NV"}],"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":"AMBIGUOUS","field":"spending","reason":"2 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"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."}