{"answer":{"query":"Qulipta","resolved_as":"applications","packages":7,"applications":["NDA215206"],"identity":{"application_numbers":["NDA215206"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2021-09-30","latest":"2026-02-06","packages_with_a_start_date":7}},"generic_entry":[{"application":"NDA215206","date":"2043-02-27","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":"12350259","productNo":"001"},"latest_patent_expiry":"2043-02-27","latest_exclusivity_expiry":"2026-09-28","dated_barriers":28,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":9,"exclusivities_listed":2,"fact_id":"d3d59a6c937ab4a594cd6b6f"}],"label_history":{"events_total":5,"non_cmc_events":5,"counts_by_class":{"LABELING":4,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA215206","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-09-30","documents":[{"type":"Label","date":"2025-10-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215206s013lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215206Orig1s013ltr..pdf","untrusted":true}}],"fact_id":"3feb59276cd68816f847537b"},{"application":"NDA215206","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-10","documents":[{"type":"Label","date":"2025-06-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215206s010s012lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-06-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215206Orig1s010;s012ltr.pdf","untrusted":true}}],"fact_id":"c903f1944a1f168d24150129"},{"application":"NDA215206","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-10","documents":[{"type":"Letter","date":"2025-06-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215206Orig1s010;s012ltr.pdf","untrusted":true}}],"fact_id":"0015246dae9d4d12e6d94334"},{"application":"NDA215206","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-21","documents":[{"type":"Label","date":"2025-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215206s011lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215206Orig1s011ltr.pdf","untrusted":true}}],"fact_id":"ce3e8e12723fcee118b02f09"},{"application":"NDA215206","submission_no":4,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-04-17","documents":[{"type":"Label","date":"2023-04-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215206s004lbl.pdf","untrusted":true}}],"fact_id":"43dfa6bafce35cb4c39b8898"}],"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":"NDA215206","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"QULIPTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"10MG","untrusted":true}},{"application":"NDA215206","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"QULIPTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"30MG","untrusted":true}},{"application":"NDA215206","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"QULIPTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"60MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Atogepant","untrusted":true},"brand":{"text":"Qulipta","untrusted":true}},"latest_year":2024,"series":[{"year":2021,"gross_spending_usd":1338318.64,"claims":1144,"beneficiaries":826,"average_spending_per_claim_usd":1169.858951,"fact_id":"5828530459ff9a5c8f0295f4"},{"year":2022,"gross_spending_usd":51325273.47,"claims":43543,"beneficiaries":12185,"average_spending_per_claim_usd":1178.7261665,"fact_id":"2b24de825d78c681c760d0a7"},{"year":2023,"gross_spending_usd":137880798.01,"claims":108350,"beneficiaries":25190,"average_spending_per_claim_usd":1272.5500509,"fact_id":"e33fa59dc74c154f4e4ea005"},{"year":2024,"gross_spending_usd":260307143.86,"claims":209816,"beneficiaries":45046,"average_spending_per_claim_usd":1240.6448691,"fact_id":"7f2eef566141d62e60ab88e3"}],"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":14,"all_states_medicaid_reimbursed_usd":1354030.08,"all_states_medicaid_paid_prescriptions":1213,"top_states":[{"state":"AL","medicaid_paid_prescriptions":173,"medicaid_reimbursed_usd":192094.93,"total_reimbursed_usd":196993.65,"packages":1,"covers":"all_record_types","fact_id":"0e399fdf2be8f286e147257d"},{"state":"ME","medicaid_paid_prescriptions":106,"medicaid_reimbursed_usd":125168.12,"total_reimbursed_usd":130914.96,"packages":1,"covers":"all_record_types","fact_id":"91d85a036c1fc3d0e9ccf80e"},{"state":"TX","medicaid_paid_prescriptions":108,"medicaid_reimbursed_usd":111802.38,"total_reimbursed_usd":121246.35,"packages":1,"covers":"all_record_types","fact_id":"e9753780545a4ee969f2adf2"},{"state":"MT","medicaid_paid_prescriptions":99,"medicaid_reimbursed_usd":111086.37,"total_reimbursed_usd":111086.37,"packages":1,"covers":"all_record_types","fact_id":"54f3b9b0e660e28b7e199680"},{"state":"PR","medicaid_paid_prescriptions":90,"medicaid_reimbursed_usd":105981.47,"total_reimbursed_usd":105981.47,"packages":1,"covers":"all_record_types","fact_id":"99f549f22d1d4782cf1b02be"},{"state":"OK","medicaid_paid_prescriptions":90,"medicaid_reimbursed_usd":98723.99,"total_reimbursed_usd":105603.59,"packages":1,"covers":"fee_for_service_only","fact_id":"543c97578698ef58771dd455"},{"state":"OR","medicaid_paid_prescriptions":80,"medicaid_reimbursed_usd":88100.13,"total_reimbursed_usd":88100.13,"packages":1,"covers":"fee_for_service_only","fact_id":"1c4d8a61a150ca063b193871"},{"state":"ID","medicaid_paid_prescriptions":73,"medicaid_reimbursed_usd":83691.51,"total_reimbursed_usd":83691.51,"packages":1,"covers":"all_record_types","fact_id":"457c6824458b948fd5ef1fe8"},{"state":"ND","medicaid_paid_prescriptions":76,"medicaid_reimbursed_usd":83299.05,"total_reimbursed_usd":83299.05,"packages":1,"covers":"all_record_types","fact_id":"8a6ce8e86115a10a48819298"},{"state":"MN","medicaid_paid_prescriptions":70,"medicaid_reimbursed_usd":80122.55,"total_reimbursed_usd":80122.55,"packages":1,"covers":"fee_for_service_only","fact_id":"639570d92edac9cc4edfa138"}],"unlabelled_state_code_xx":null,"built_from_facts":14,"facts_fee_for_service_only":6,"older_year_facts_not_used":100,"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":"17314a42edc2d31c88e5134f","field":"ndc.listing","entity":"ndc:00074709404"},{"fact_id":"ff92eddfcec4eda6991836fd","field":"ndc.listing","entity":"ndc:00074709430"},{"fact_id":"c112e27c632f10fdf5e4e8b7","field":"ndc.listing","entity":"ndc:00074709470"},{"fact_id":"d3d59a6c937ab4a594cd6b6f","field":"drug.generic_entry_earliest","entity":"application:NDA215206"},{"fact_id":"68371ecfd1a52818ba7ff56f","field":"drug.patent","entity":"application:NDA215206"},{"fact_id":"a809be432acf56a880a6b1d0","field":"drug.exclusivity","entity":"application:NDA215206"},{"fact_id":"3feb59276cd68816f847537b","field":"drug.label_event","entity":"application:NDA215206"},{"fact_id":"c903f1944a1f168d24150129","field":"drug.label_event","entity":"application:NDA215206"},{"fact_id":"0015246dae9d4d12e6d94334","field":"drug.label_event","entity":"application:NDA215206"},{"fact_id":"ce3e8e12723fcee118b02f09","field":"drug.label_event","entity":"application:NDA215206"},{"fact_id":"43dfa6bafce35cb4c39b8898","field":"drug.label_event","entity":"application:NDA215206"},{"fact_id":"d187b281ee61f6edf4187bf8","field":"drug.marketing_status","entity":"application:NDA215206"},{"fact_id":"1debf53dee53051eb649491a","field":"drug.marketing_status","entity":"application:NDA215206"},{"fact_id":"129421cba8fe96f5879f67f8","field":"drug.marketing_status","entity":"application:NDA215206"},{"fact_id":"5828530459ff9a5c8f0295f4","field":"drug.partd_spending","entity":"drug:atogepant|qulipta"},{"fact_id":"2b24de825d78c681c760d0a7","field":"drug.partd_spending","entity":"drug:atogepant|qulipta"},{"fact_id":"e33fa59dc74c154f4e4ea005","field":"drug.partd_spending","entity":"drug:atogepant|qulipta"},{"fact_id":"7f2eef566141d62e60ab88e3","field":"drug.partd_spending","entity":"drug:atogepant|qulipta"},{"fact_id":"0e399fdf2be8f286e147257d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00074709630:AL"},{"fact_id":"91d85a036c1fc3d0e9ccf80e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00074709630:ME"},{"fact_id":"e9753780545a4ee969f2adf2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00074709530:TX"},{"fact_id":"54f3b9b0e660e28b7e199680","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00074709630:MT"},{"fact_id":"99f549f22d1d4782cf1b02be","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00074709430:PR"},{"fact_id":"543c97578698ef58771dd455","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00074709630:OK"},{"fact_id":"1c4d8a61a150ca063b193871","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00074709630:OR"},{"fact_id":"457c6824458b948fd5ef1fe8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00074709530:ID"},{"fact_id":"8a6ce8e86115a10a48819298","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00074709430:ND"},{"fact_id":"639570d92edac9cc4edfa138","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00074709530:MN"}],"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":"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":"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."}