{"answer":{"query":"Atrovent HFA","resolved_as":"applications","packages":1,"applications":["NDA021527"],"identity":{"application_numbers":["NDA021527"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"AEROSOL, METERED","untrusted":true}],"marketing_start":{"earliest":"2005-05-01","latest":"2005-05-01","packages_with_a_start_date":1}},"generic_entry":[{"application":"NDA021527","date":"2030-01-17","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":"8474447","productNo":"001"},"latest_patent_expiry":"2030-01-17","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":1,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":0,"fact_id":"8026e18500c5e6cb9729866e"}],"label_history":{"events_total":12,"non_cmc_events":8,"counts_by_class":{"LABELING":8},"cmc_events":4,"recent_non_cmc_events":[{"application":"NDA021527","submission_no":42,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-12-30","documents":[{"type":"Letter","date":"2025-01-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021527Orig1s042ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-01-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021527Orig1s042lbl.pdf","untrusted":true}}],"fact_id":"b43954295ce94270ad965e8a"},{"application":"NDA021527","submission_no":33,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-01-10","documents":[{"type":"Letter","date":"2020-01-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021527Orig1s033ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-01-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021527s033lbl.pdf","untrusted":true}}],"fact_id":"e6dfcc39243dee4ae9ccbc94"},{"application":"NDA021527","submission_no":27,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-08-11","documents":[{"type":"Letter","date":"2021-08-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021527Orig1s027ltr.pdf","untrusted":true}}],"fact_id":"f825b047085fceb24493239e"},{"application":"NDA021527","submission_no":21,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2012-08-30","documents":[{"type":"Letter","date":"2012-08-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021527Orig1s021ltr.pdf","untrusted":true}},{"type":"Label","date":"2012-08-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021527s021lbl.pdf","untrusted":true}}],"fact_id":"cb7a614b965368931623a6ab"},{"application":"NDA021527","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2010-12-23","documents":[{"type":"Letter","date":"2010-12-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021527s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2010-12-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021527s016lbl.pdf","untrusted":true}}],"fact_id":"30e18257818263aa63894cd5"}],"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":"NDA021527","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"ATROVENT HFA","untrusted":true},"form":{"text":"AEROSOL, METERED;INHALATION","untrusted":true},"strength":{"text":"0.021MG/INH","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Ipratropium Bromide","untrusted":true},"brand":{"text":"Atrovent HFA","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":131773397.76,"claims":254557,"beneficiaries":71687,"average_spending_per_claim_usd":517.65772601,"fact_id":"88cd8bef4e6fccdaff6a527b"},{"year":2021,"gross_spending_usd":133670252.55,"claims":244810,"beneficiaries":69491,"average_spending_per_claim_usd":546.01630877,"fact_id":"c1f7988bd0407baa4d856f0c"},{"year":2022,"gross_spending_usd":134769804.13,"claims":235718,"beneficiaries":69939,"average_spending_per_claim_usd":571.74167493,"fact_id":"486a28386c05f8909b9748cb"},{"year":2023,"gross_spending_usd":131864275.2,"claims":221950,"beneficiaries":68099,"average_spending_per_claim_usd":594.11703176,"fact_id":"97232eb6a8f8609b7f4769fd"},{"year":2024,"gross_spending_usd":115305947.38,"claims":200254,"beneficiaries":62582,"average_spending_per_claim_usd":575.79847284,"fact_id":"19c3c27161ebea08ef9232bc"}],"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; 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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":"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":"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."}