{"answer":{"query":"Abilify Maintena","resolved_as":"applications","packages":5,"applications":["NDA202971"],"identity":{"application_numbers":["NDA202971"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2014-10-08","latest":"2025-02-28","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA202971","date":"2041-04-01","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":"12691056","productNo":"003"},"latest_patent_expiry":"2041-04-01","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":28,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":0,"fact_id":"55e2df6c74e281fb76d05493"}],"label_history":{"events_total":16,"non_cmc_events":10,"counts_by_class":{"LABELING":6,"EFFICACY":4},"cmc_events":6,"recent_non_cmc_events":[{"application":"NDA202971","submission_no":20,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-01-28","documents":[{"type":"Letter","date":"2026-01-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202971Orig1s020ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-01-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/202971Orig1s020lbl.pdf","untrusted":true}}],"fact_id":"b573049611e81341c45496b0"},{"application":"NDA202971","submission_no":18,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-03-28","documents":[{"type":"Label","date":"2026-03-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/202971s018,217006s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-04-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202971Orig1s018, 217006Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"4b825accbc4aae712f578623"},{"application":"NDA202971","submission_no":19,"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/2025/202971s019lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021436Orig1s046s050;202971Orig1s019;207202Orig1s009;217006Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"8fb44c2f623ae682f34ca2a9"},{"application":"NDA202971","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-02-05","documents":[{"type":"Letter","date":"2020-02-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021436Orig1s044, s045; 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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":"NDA202971","product_no":"001","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"ABILIFY MAINTENA KIT","untrusted":true},"form":{"text":"FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"300MG/VIAL","untrusted":true}},{"application":"NDA202971","product_no":"002","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"ABILIFY MAINTENA KIT","untrusted":true},"form":{"text":"FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"400MG/VIAL","untrusted":true}},{"application":"NDA202971","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ABILIFY MAINTENA KIT","untrusted":true},"form":{"text":"FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"300MG","untrusted":true}},{"application":"NDA202971","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ABILIFY MAINTENA KIT","untrusted":true},"form":{"text":"FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"400MG","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","untrusted":true},"brand":{"text":"Abilify Maintena","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":460313112.01,"claims":203218,"beneficiaries":25646,"average_spending_per_claim_usd":2265.1197827,"fact_id":"98a2db73e1b1398e6ae477d1"},{"year":2021,"gross_spending_usd":499429110.88,"claims":208784,"beneficiaries":26393,"average_spending_per_claim_usd":2392.0851736,"fact_id":"89e9fe85c6e5e937518dd953"},{"year":2022,"gross_spending_usd":563682902.82,"claims":219843,"beneficiaries":27676,"average_spending_per_claim_usd":2564.0247941,"fact_id":"8f42b19518bf456ffd1e7a76"},{"year":2023,"gross_spending_usd":636857890.94,"claims":232162,"beneficiaries":29378,"average_spending_per_claim_usd":2743.1616326,"fact_id":"cf007bef104b823d4bb2dd2e"},{"year":2024,"gross_spending_usd":644233417.74,"claims":235220,"beneficiaries":29911,"average_spending_per_claim_usd":2738.8547646,"fact_id":"cc25f3211ae50f4575e4f8f0"}],"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":"J0401","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":7.456,"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":"b8690fdde03488e2ca6e9cda"}],"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"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"Aripiprazole; aripiprazole","untrusted":true},"designation_count":3,"approved_count":1,"recent":[{"designated":"2025-07-08","use":{"text":"treatment of malignant glioma","untrusted":true},"status":"Designated","sponsor":{"text":"VSPharmTech Co., LTD.","untrusted":true},"approved":false},{"designated":"2019-07-22","use":{"text":"Treatment of N-glycanase 1 (NGLY1) deficiency","untrusted":true},"status":"Designated","sponsor":{"text":"Perlara PBC","untrusted":true},"approved":false},{"designated":"2006-01-25","use":{"text":"Treatment of Tourette's syndrome","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Otsuka Pharmaceutical Development","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"2eb7608779ee8a5f6cdc46d0"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":2,"all_states_medicaid_reimbursed_usd":638393.04,"all_states_medicaid_paid_prescriptions":255,"top_states":[{"state":"VT","medicaid_paid_prescriptions":151,"medicaid_reimbursed_usd":418814.9,"total_reimbursed_usd":418814.9,"packages":1,"covers":"all_record_types","fact_id":"0c31ddca37266eac8f4570ce"},{"state":"RI","medicaid_paid_prescriptions":104,"medicaid_reimbursed_usd":219578.14,"total_reimbursed_usd":219578.14,"packages":1,"covers":"fee_for_service_only","fact_id":"9923189b7af22977e811f997"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":1,"older_year_facts_not_used":97,"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":"009871708817db85efaebcd9","field":"ndc.listing","entity":"ndc:59148004580"},{"fact_id":"492f9b4e7ea60e1c49887a65","field":"ndc.listing","entity":"ndc:59148007280"},{"fact_id":"b30d174e605256c40d692f62","field":"ndc.listing","entity":"ndc:59148007292"},{"fact_id":"55e2df6c74e281fb76d05493","field":"drug.generic_entry_earliest","entity":"application:NDA202971"},{"fact_id":"654162fd6e0557c7ca9fcc92","field":"drug.patent","entity":"application:NDA202971"},{"fact_id":"b573049611e81341c45496b0","field":"drug.label_event","entity":"application:NDA202971"},{"fact_id":"4b825accbc4aae712f578623","field":"drug.label_event","entity":"application:NDA202971"},{"fact_id":"8fb44c2f623ae682f34ca2a9","field":"drug.label_event","entity":"application:NDA202971"},{"fact_id":"3147147f87583ff18bc6d57b","field":"drug.label_event","entity":"application:NDA202971"},{"fact_id":"3b567dc0b366da8b88c65585","field":"drug.label_event","entity":"application:NDA202971"},{"fact_id":"643e1f533a49e34fcfc3ce1c","field":"drug.te_code","entity":"application:NDA202971"},{"fact_id":"cd33b7502702da8262f84ff7","field":"drug.marketing_status","entity":"application:NDA202971"},{"fact_id":"09d0a326c6a2f66c9356fbea","field":"drug.te_code","entity":"application:NDA202971"},{"fact_id":"1d5478ad436c770188d9a3d9","field":"drug.marketing_status","entity":"application:NDA202971"},{"fact_id":"a03bb6e637076a404d5cbf1f","field":"drug.marketing_status","entity":"application:NDA202971"},{"fact_id":"70f2f05a5def2ec9db360f5c","field":"drug.marketing_status","entity":"application:NDA202971"},{"fact_id":"98a2db73e1b1398e6ae477d1","field":"drug.partd_spending","entity":"drug:aripiprazole|abilify-maintena"},{"fact_id":"89e9fe85c6e5e937518dd953","field":"drug.partd_spending","entity":"drug:aripiprazole|abilify-maintena"},{"fact_id":"8f42b19518bf456ffd1e7a76","field":"drug.partd_spending","entity":"drug:aripiprazole|abilify-maintena"},{"fact_id":"cf007bef104b823d4bb2dd2e","field":"drug.partd_spending","entity":"drug:aripiprazole|abilify-maintena"},{"fact_id":"cc25f3211ae50f4575e4f8f0","field":"drug.partd_spending","entity":"drug:aripiprazole|abilify-maintena"},{"fact_id":"b8690fdde03488e2ca6e9cda","field":"drug.asp_price","entity":"hcpcs:J0401"},{"fact_id":"2eb7608779ee8a5f6cdc46d0","field":"drug.orphan_designation","entity":"drug:aripiprazole"},{"fact_id":"0c31ddca37266eac8f4570ce","field":"ndc.medicaid_state_utilization","entity":"ndc_state:59148007280:VT"},{"fact_id":"9923189b7af22977e811f997","field":"ndc.medicaid_state_utilization","entity":"ndc_state:59148004580:RI"}],"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":"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":"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":"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."}