{"answer":{"query":"Aristada","resolved_as":"applications","packages":8,"applications":["NDA207533"],"identity":{"application_numbers":["NDA207533"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SUSPENSION, EXTENDED RELEASE","untrusted":true}],"marketing_start":{"earliest":"2015-10-05","latest":"2017-06-05","packages_with_a_start_date":8}},"generic_entry":[{"application":"NDA207533","date":"2039-04-06","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":"11273158","productNo":"002"},"latest_patent_expiry":"2039-04-06","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":70,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":18,"exclusivities_listed":0,"fact_id":"78c45029288de50068f35c24"}],"label_history":{"events_total":9,"non_cmc_events":8,"counts_by_class":{"LABELING":7,"EFFICACY":1},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA207533","submission_no":31,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-22","documents":[{"type":"Label","date":"2025-02-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207533s031lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207533Orig1s031,209830Orig1s020ltr.pdf","untrusted":true}}],"fact_id":"24a6fb243e46cb7cd354f4a6"},{"application":"NDA207533","submission_no":21,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-03-30","documents":[{"type":"Letter","date":"2021-03-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207533Orig1s021,209830Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"2855e80d6f125566319b9238"},{"application":"NDA207533","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-08-27","documents":[{"type":"Letter","date":"2020-08-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/207533Orig1s017, 209830Orig1s005ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-09-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/207533s017,209830s005lbl.pdf","untrusted":true}}],"fact_id":"7f44232c0879c6f0993a7815"},{"application":"NDA207533","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-11-30","documents":[{"type":"Label","date":"2018-12-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207533s013lbl.pdf","untrusted":true}}],"fact_id":"836993b26aa1a749a08143fb"},{"application":"NDA207533","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-01-25","documents":[{"type":"Letter","date":"2018-01-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207533Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"700e55c61972bbc53a4674da"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":4,"te_code_counts":{"NOT_PROVIDED":4},"marketing_status_counts":{"Prescription":4},"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":"NDA207533","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ARISTADA","untrusted":true},"form":{"text":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"1064MG/3.9ML (272.82MG/ML)","untrusted":true}},{"application":"NDA207533","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ARISTADA","untrusted":true},"form":{"text":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"441MG/1.6ML (275.63MG/ML)","untrusted":true}},{"application":"NDA207533","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ARISTADA","untrusted":true},"form":{"text":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"662MG/2.4ML (275.83MG/ML)","untrusted":true}},{"application":"NDA207533","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ARISTADA","untrusted":true},"form":{"text":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"882MG/3.2ML (275.63MG/ML)","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Otsuka Patient Assistance Foundation","untrusted":true},"type":"manufacturer","url":"https://www.otsuka-us.com/patient-assistance","status":null,"needs_status_check":false,"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":"Aripiprazole Lauroxil","untrusted":true},"brand":{"text":"Aristada","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":203135526.91,"claims":76175,"beneficiaries":11836,"average_spending_per_claim_usd":2666.6954632,"fact_id":"98ea4585f864e06849eb4e66"},{"year":2021,"gross_spending_usd":230380653.29,"claims":82292,"beneficiaries":12813,"average_spending_per_claim_usd":2799.5510291,"fact_id":"3409a5cd9157040e4789d733"},{"year":2022,"gross_spending_usd":256918832.21,"claims":88507,"beneficiaries":13161,"average_spending_per_claim_usd":2902.8080515,"fact_id":"1ccc0694d30d0e862f7d0f56"},{"year":2023,"gross_spending_usd":272878290.93,"claims":90583,"beneficiaries":13295,"average_spending_per_claim_usd":3012.4669191,"fact_id":"8b7cf1675dd210209f243c28"},{"year":2024,"gross_spending_usd":269076004.88,"claims":90057,"beneficiaries":13102,"average_spending_per_claim_usd":2987.8410882,"fact_id":"e766d8b510dfda6819f2c566"}],"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}}},"payment_limit":{"codes":[{"hcpcs":"J1944","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":3.55,"dosage_descriptor":{"text":"1 MG","untrusted":true},"packages_matched":4,"read_on":"2026-11-07T07:31:28.000Z","source_url":{"text":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","untrusted":true},"fact_id":"d5a416f3a4944b307aa2dc3c"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; not a price a patient pays, and the presence of a code does not indicate that Medicare covers a product"},"medicaid_state_utilization":{"year":2025,"states_with_data":7,"all_states_medicaid_reimbursed_usd":13337231.9,"all_states_medicaid_paid_prescriptions":5092,"top_states":[{"state":"NC","medicaid_paid_prescriptions":2900,"medicaid_reimbursed_usd":7881519.91,"total_reimbursed_usd":8057166.36,"packages":4,"covers":"fee_for_service_only","fact_id":"7fdf409278e96fd3a98138cc"},{"state":"IA","medicaid_paid_prescriptions":1393,"medicaid_reimbursed_usd":3622093.62,"total_reimbursed_usd":3631985.73,"packages":2,"covers":"fee_for_service_only","fact_id":"ad47b31a5a85db6ae046ada7"},{"state":"RI","medicaid_paid_prescriptions":285,"medicaid_reimbursed_usd":871621.11,"total_reimbursed_usd":871621.11,"packages":1,"covers":"fee_for_service_only","fact_id":"3da2453450d0067b532ea100"},{"state":"IL","medicaid_paid_prescriptions":278,"medicaid_reimbursed_usd":458912.52,"total_reimbursed_usd":458912.52,"packages":1,"covers":"fee_for_service_only","fact_id":"e9a7792b8a8cc65d7b95b0b8"},{"state":"ME","medicaid_paid_prescriptions":125,"medicaid_reimbursed_usd":334822.73,"total_reimbursed_usd":352785.54,"packages":2,"covers":"all_record_types","fact_id":"bc85c57330494f67909d1a37"},{"state":"WV","medicaid_paid_prescriptions":65,"medicaid_reimbursed_usd":98424.68,"total_reimbursed_usd":98424.68,"packages":1,"covers":"all_record_types","fact_id":"5b433cdcfc6e57933cc11be0"},{"state":"MS","medicaid_paid_prescriptions":46,"medicaid_reimbursed_usd":69837.33,"total_reimbursed_usd":69837.33,"packages":1,"covers":"fee_for_service_only","fact_id":"a1090ffe2df2493a687d657e"}],"unlabelled_state_code_xx":null,"built_from_facts":12,"facts_fee_for_service_only":9,"older_year_facts_not_used":177,"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":"31fac4678dc702af181d301c","field":"ndc.listing","entity":"ndc:65757040103"},{"fact_id":"d98d13f4a8f0d7532eea4f4d","field":"ndc.listing","entity":"ndc:65757040104"},{"fact_id":"10e2fbc6e2a90f6cb48ced56","field":"ndc.listing","entity":"ndc:65757040203"},{"fact_id":"78c45029288de50068f35c24","field":"drug.generic_entry_earliest","entity":"application:NDA207533"},{"fact_id":"e7a1f59ee3344ff74b08fef8","field":"drug.patent","entity":"application:NDA207533"},{"fact_id":"24a6fb243e46cb7cd354f4a6","field":"drug.label_event","entity":"application:NDA207533"},{"fact_id":"2855e80d6f125566319b9238","field":"drug.label_event","entity":"application:NDA207533"},{"fact_id":"7f44232c0879c6f0993a7815","field":"drug.label_event","entity":"application:NDA207533"},{"fact_id":"836993b26aa1a749a08143fb","field":"drug.label_event","entity":"application:NDA207533"},{"fact_id":"700e55c61972bbc53a4674da","field":"drug.label_event","entity":"application:NDA207533"},{"fact_id":"f602d348eb1b2d1e56fb5aff","field":"drug.marketing_status","entity":"application:NDA207533"},{"fact_id":"ec518b96eb28b9e732dc030c","field":"drug.marketing_status","entity":"application:NDA207533"},{"fact_id":"5af407ada67110a48b328013","field":"drug.marketing_status","entity":"application:NDA207533"},{"fact_id":"59b3848431472fe25ee8e885","field":"drug.marketing_status","entity":"application:NDA207533"},{"fact_id":"98ea4585f864e06849eb4e66","field":"drug.partd_spending","entity":"drug:aripiprazole-lauroxil|aristada"},{"fact_id":"3409a5cd9157040e4789d733","field":"drug.partd_spending","entity":"drug:aripiprazole-lauroxil|aristada"},{"fact_id":"1ccc0694d30d0e862f7d0f56","field":"drug.partd_spending","entity":"drug:aripiprazole-lauroxil|aristada"},{"fact_id":"8b7cf1675dd210209f243c28","field":"drug.partd_spending","entity":"drug:aripiprazole-lauroxil|aristada"},{"fact_id":"e766d8b510dfda6819f2c566","field":"drug.partd_spending","entity":"drug:aripiprazole-lauroxil|aristada"},{"fact_id":"d5a416f3a4944b307aa2dc3c","field":"drug.asp_price","entity":"hcpcs:J1944"},{"fact_id":"7fdf409278e96fd3a98138cc","field":"ndc.medicaid_state_utilization","entity":"ndc_state:65757040303:NC"},{"fact_id":"ad47b31a5a85db6ae046ada7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:65757040303:IA"},{"fact_id":"3da2453450d0067b532ea100","field":"ndc.medicaid_state_utilization","entity":"ndc_state:65757040303:RI"},{"fact_id":"e9a7792b8a8cc65d7b95b0b8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:65757040103:IL"},{"fact_id":"bc85c57330494f67909d1a37","field":"ndc.medicaid_state_utilization","entity":"ndc_state:65757040403:ME"},{"fact_id":"5b433cdcfc6e57933cc11be0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:65757040103:WV"},{"fact_id":"a1090ffe2df2493a687d657e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:65757040103:MS"}],"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":"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":"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."}