{"answer":{"query":"Combivent Respimat","resolved_as":"applications","packages":1,"applications":["NDA021747"],"identity":{"application_numbers":["NDA021747"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SPRAY, METERED","untrusted":true}],"marketing_start":{"earliest":"2012-07-01","latest":"2012-07-01","packages_with_a_start_date":1}},"generic_entry":[{"application":"NDA021747","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":4,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":0,"fact_id":"080859d992f1840c4c078ecb"}],"label_history":{"events_total":12,"non_cmc_events":5,"counts_by_class":{"LABELING":5},"cmc_events":7,"recent_non_cmc_events":[{"application":"NDA021747","submission_no":20,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-09-27","documents":[{"type":"Letter","date":"2020-09-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021747Orig1s020ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-09-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021747s020lbl.pdf","untrusted":true}}],"fact_id":"c724f52b6abf9f09db5df276"},{"application":"NDA021747","submission_no":13,"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/2016/021747Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2016-06-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s013lbl.pdf","untrusted":true}}],"fact_id":"a224e3158ce97df12957fa94"},{"application":"NDA021747","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-01-29","documents":[{"type":"Letter","date":"2016-02-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021747Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2016-02-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021747s010lbl.pdf","untrusted":true}}],"fact_id":"235a22533bda495ec810c571"},{"application":"NDA021747","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2014-10-17","documents":[{"type":"Label","date":"2014-10-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021747s005lbl.pdf","untrusted":true}},{"type":"Letter","date":"2014-10-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021747Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"cf98443bdd007d8a99e5562e"},{"application":"NDA021747","submission_no":1,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2012-08-29","documents":[{"type":"Letter","date":"2012-08-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021747Orig1s001ltr.pdf","untrusted":true}},{"type":"Label","date":"2012-08-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021747s001lbl.pdf","untrusted":true}}],"fact_id":"6a4a5b48e389caa3f4ca3a76"}],"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":"NDA021747","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"COMBIVENT RESPIMAT","untrusted":true},"form":{"text":"SPRAY, METERED;INHALATION","untrusted":true},"strength":{"text":"EQ 0.1MG BASE/INH;0.02MG/INH","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":1,"most_recent":[{"recall_number":"D-1279-2015","classification":"Class II","status":"Terminated","report_date":"2015-08-05","recall_initiated":"2015-07-24","recalling_firm":{"text":"Boehringer Ingelheim Roxane Inc","untrusted":true},"reason":{"text":"Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short transient spray.","untrusted":true},"packages_named":1,"fact_id":"8de0e4f7276373bfcc5922f5"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Ipratropium/Albuterol Sulfate","untrusted":true},"brand":{"text":"Combivent Respimat","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":546288280.29,"claims":930933,"beneficiaries":239713,"average_spending_per_claim_usd":586.818042,"fact_id":"355591882633dc1e95be4dd0"},{"year":2021,"gross_spending_usd":520262761.18,"claims":838701,"beneficiaries":214438,"average_spending_per_claim_usd":620.3197101,"fact_id":"c312ebc00b9d2bf1d36eacb9"},{"year":2022,"gross_spending_usd":484615822.22,"claims":752921,"beneficiaries":192415,"average_spending_per_claim_usd":643.64763663,"fact_id":"dff99ac46d99a0b871d09f2f"},{"year":2023,"gross_spending_usd":456397647.02,"claims":683764,"beneficiaries":176341,"average_spending_per_claim_usd":667.4783215,"fact_id":"aae9cf495bb26b0abde1fd20"},{"year":2024,"gross_spending_usd":387905151.22,"claims":602035,"beneficiaries":154264,"average_spending_per_claim_usd":644.32325566,"fact_id":"e54bd8b0348d44d1484a67f7"}],"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":94648485.01,"all_states_medicaid_paid_prescriptions":188595,"top_states":[{"state":"CA","medicaid_paid_prescriptions":23041,"medicaid_reimbursed_usd":12426524.33,"total_reimbursed_usd":12536895.32,"packages":1,"covers":"all_record_types","fact_id":"ed354afa7e21c510ef3bba82"},{"state":"NY","medicaid_paid_prescriptions":15890,"medicaid_reimbursed_usd":8543988.54,"total_reimbursed_usd":8757241.23,"packages":1,"covers":"all_record_types","fact_id":"32b391f09d9e6d657ed69fc0"},{"state":"MO","medicaid_paid_prescriptions":10831,"medicaid_reimbursed_usd":5186424.29,"total_reimbursed_usd":5191987.1,"packages":1,"covers":"all_record_types","fact_id":"5cba7cdb62c90e28d1b11a4f"},{"state":"KY","medicaid_paid_prescriptions":10368,"medicaid_reimbursed_usd":4678464.33,"total_reimbursed_usd":4678464.33,"packages":1,"covers":"all_record_types","fact_id":"9862dae6aff2516c1a9d7ad2"},{"state":"PA","medicaid_paid_prescriptions":9278,"medicaid_reimbursed_usd":4671796.31,"total_reimbursed_usd":4752747.3,"packages":1,"covers":"all_record_types","fact_id":"1bfc7d2d20fcbb0d4af0958b"},{"state":"WI","medicaid_paid_prescriptions":9493,"medicaid_reimbursed_usd":4496084.68,"total_reimbursed_usd":4625594.23,"packages":1,"covers":"all_record_types","fact_id":"7d67c18afd90b91d4e40a84e"},{"state":"MI","medicaid_paid_prescriptions":6635,"medicaid_reimbursed_usd":3439374.43,"total_reimbursed_usd":3446916.17,"packages":1,"covers":"all_record_types","fact_id":"c5eeee00265d247e2696e96e"},{"state":"IN","medicaid_paid_prescriptions":5803,"medicaid_reimbursed_usd":3107043.88,"total_reimbursed_usd":3120617.92,"packages":1,"covers":"all_record_types","fact_id":"1dd657c8aba7e7f5c6566c09"},{"state":"TX","medicaid_paid_prescriptions":5946,"medicaid_reimbursed_usd":2933743.22,"total_reimbursed_usd":2965930.43,"packages":1,"covers":"fee_for_service_only","fact_id":"5b988a269724ca1d19c9fc07"},{"state":"WA","medicaid_paid_prescriptions":5497,"medicaid_reimbursed_usd":2822806.02,"total_reimbursed_usd":2834968.94,"packages":1,"covers":"all_record_types","fact_id":"e950fbc182e7c22a95474ed0"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":198615,"medicaid_reimbursed_usd":99963161.82,"note":"the source uses the code XX without defining it; 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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":"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":"AMBIGUOUS","field":"spending","reason":"3 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."}