{"answer":{"query":"Invega Sustenna","resolved_as":"applications","packages":7,"applications":["NDA022264"],"identity":{"application_numbers":["NDA022264"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"INJECTION","untrusted":true}],"marketing_start":{"earliest":"2009-07-31","latest":"2009-07-31","packages_with_a_start_date":7}},"generic_entry":[{"application":"NDA022264","date":"2031-01-26","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":"9439906","productNo":"001"},"latest_patent_expiry":"2031-01-26","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":5,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":0,"fact_id":"ec22145f831f177ec3b333d7"}],"label_history":{"events_total":24,"non_cmc_events":20,"counts_by_class":{"LABELING":16,"EFFICACY":4},"cmc_events":4,"recent_non_cmc_events":[{"application":"NDA022264","submission_no":38,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-23","documents":[{"type":"Label","date":"2025-03-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/021999Orig1s040, s041; 022264Orig1s038; 207946Orig1s01lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/021999Orig1s040,s041;022264Orig1s038;207946Orig1s017ltr.pdf","untrusted":true}}],"fact_id":"10070d378ac25269c182ce42"},{"application":"NDA022264","submission_no":37,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-09-12","documents":[{"type":"Letter","date":"2024-09-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022264Orig1s037; 207946Orig1s014; 015ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-09-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022264s037lbledt.pdf","untrusted":true}}],"fact_id":"f31ce9ec15758d570fa7df73"},{"application":"NDA022264","submission_no":34,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-07-29","documents":[{"type":"Letter","date":"2022-08-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022264Orig1s034ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-08-10","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022264s034lbl.pdf","untrusted":true}}],"fact_id":"33c8d23dd67fb4cfc4d85bdc"},{"application":"NDA022264","submission_no":33,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-08-09","documents":[{"type":"Letter","date":"2021-08-10","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022264Orig1s033ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-08-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022264Orig1s033lbl.pdf","untrusted":true}}],"fact_id":"9ace76cace764e19bf934dff"},{"application":"NDA022264","submission_no":30,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-02-12","documents":[{"type":"Letter","date":"2021-02-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021999Orig1s037, 022264Orig1s030, 207946Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-02-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021999Orig1s037,022264Orig1s030,207946Orig1s009rpllbl.pdf","untrusted":true}}],"fact_id":"8fd2727c6aa639b60efa6eaf"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":5,"te_code_counts":{"AB":5},"marketing_status_counts":{"Prescription":5},"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":"NDA022264","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INVEGA SUSTENNA","untrusted":true},"form":{"text":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"78MG/0.5ML (78MG/0.5ML)","untrusted":true}},{"application":"NDA022264","product_no":"004","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INVEGA SUSTENNA","untrusted":true},"form":{"text":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"156MG/ML (156MG/ML)","untrusted":true}},{"application":"NDA022264","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INVEGA SUSTENNA","untrusted":true},"form":{"text":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"39MG/0.25ML (39MG/0.25ML)","untrusted":true}},{"application":"NDA022264","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INVEGA SUSTENNA","untrusted":true},"form":{"text":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"117MG/0.75ML (117MG/0.75ML)","untrusted":true}},{"application":"NDA022264","product_no":"005","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INVEGA SUSTENNA","untrusted":true},"form":{"text":"SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR","untrusted":true},"strength":{"text":"234MG/1.5ML (156MG/ML)","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Paliperidone Palmitate","untrusted":true},"brand":{"text":"Invega Sustenna","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":1372610288.5,"claims":566718,"beneficiaries":65779,"average_spending_per_claim_usd":2422.0340425,"fact_id":"0a9a0306a3baa87b3a89932c"},{"year":2021,"gross_spending_usd":1502429443.6,"claims":583249,"beneficiaries":67265,"average_spending_per_claim_usd":2575.9657429,"fact_id":"a8e9150e42eb5f1b922072c3"},{"year":2022,"gross_spending_usd":1643708962.3,"claims":596038,"beneficiaries":69001,"average_spending_per_claim_usd":2757.7251154,"fact_id":"a462b414e209d30799946f87"},{"year":2023,"gross_spending_usd":1821418393.2,"claims":612670,"beneficiaries":70988,"average_spending_per_claim_usd":2972.9191786,"fact_id":"33ea742a0f6c2776a1ee951c"},{"year":2024,"gross_spending_usd":1878155857.4,"claims":624867,"beneficiaries":72112,"average_spending_per_claim_usd":3005.6889824,"fact_id":"26805f1096572c814964571d"}],"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":"J2426","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":15.437,"dosage_descriptor":{"text":"1 MG","untrusted":true},"packages_matched":5,"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":"f3ba0bc946203fc4e509bc4d"}],"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":719846.83,"all_states_medicaid_paid_prescriptions":839,"top_states":[{"state":"NC","medicaid_paid_prescriptions":244,"medicaid_reimbursed_usd":272573.28,"total_reimbursed_usd":274805.16,"packages":1,"covers":"fee_for_service_only","fact_id":"cd3dd36a057aa279b98ffed8"},{"state":"OH","medicaid_paid_prescriptions":232,"medicaid_reimbursed_usd":219960.75,"total_reimbursed_usd":219960.75,"packages":2,"covers":"fee_for_service_only","fact_id":"5a348a119cf1b35bd14f4924"},{"state":"KS","medicaid_paid_prescriptions":73,"medicaid_reimbursed_usd":84032.22,"total_reimbursed_usd":84032.22,"packages":1,"covers":"all_record_types","fact_id":"7c99f5a070b3d573d919dbb4"},{"state":"MD","medicaid_paid_prescriptions":78,"medicaid_reimbursed_usd":45072.64,"total_reimbursed_usd":45135.64,"packages":1,"covers":"all_record_types","fact_id":"279e3c70ea3f32cfa205defb"},{"state":"NJ","medicaid_paid_prescriptions":72,"medicaid_reimbursed_usd":38091.09,"total_reimbursed_usd":44611.18,"packages":1,"covers":"all_record_types","fact_id":"5fe22f98e4048482457bf8fe"},{"state":"MA","medicaid_paid_prescriptions":62,"medicaid_reimbursed_usd":33662.51,"total_reimbursed_usd":33662.51,"packages":1,"covers":"fee_for_service_only","fact_id":"032a0112961aeee81ec2f880"},{"state":"HI","medicaid_paid_prescriptions":78,"medicaid_reimbursed_usd":26454.34,"total_reimbursed_usd":26454.34,"packages":1,"covers":"all_record_types","fact_id":"abbf40e9a9f47b8c20c79297"}],"unlabelled_state_code_xx":null,"built_from_facts":8,"facts_fee_for_service_only":4,"older_year_facts_not_used":214,"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":"9f45d4549288728852405362","field":"ndc.listing","entity":"ndc:50458056001"},{"fact_id":"f7bb7c513c7d193cdff0caf7","field":"ndc.listing","entity":"ndc:50458056101"},{"fact_id":"1d4aaefcbb6a987cb5a029a1","field":"ndc.listing","entity":"ndc:50458056201"},{"fact_id":"ec22145f831f177ec3b333d7","field":"drug.generic_entry_earliest","entity":"application:NDA022264"},{"fact_id":"cb95ab62478da30327601cb4","field":"drug.patent","entity":"application:NDA022264"},{"fact_id":"10070d378ac25269c182ce42","field":"drug.label_event","entity":"application:NDA022264"},{"fact_id":"f31ce9ec15758d570fa7df73","field":"drug.label_event","entity":"application:NDA022264"},{"fact_id":"33c8d23dd67fb4cfc4d85bdc","field":"drug.label_event","entity":"application:NDA022264"},{"fact_id":"9ace76cace764e19bf934dff","field":"drug.label_event","entity":"application:NDA022264"},{"fact_id":"8fd2727c6aa639b60efa6eaf","field":"drug.label_event","entity":"application:NDA022264"},{"fact_id":"fdbcc140b7f58b1356db9bc4","field":"drug.te_code","entity":"application:NDA022264"},{"fact_id":"55feae5fbbc9f3a10499410b","field":"drug.marketing_status","entity":"application:NDA022264"},{"fact_id":"d754d2531d7f2000030f4f3a","field":"drug.te_code","entity":"application:NDA022264"},{"fact_id":"f8cb5030592a6fcf56813cd6","field":"drug.marketing_status","entity":"application:NDA022264"},{"fact_id":"d36368219884632952026ef7","field":"drug.te_code","entity":"application:NDA022264"},{"fact_id":"b9c82346e3c555b03d30fb42","field":"drug.marketing_status","entity":"application:NDA022264"},{"fact_id":"975d2905a4a44e11e2344df4","field":"drug.te_code","entity":"application:NDA022264"},{"fact_id":"f9e3230893c239138bb02c96","field":"drug.marketing_status","entity":"application:NDA022264"},{"fact_id":"6e8aed56b36555db755febd5","field":"drug.te_code","entity":"application:NDA022264"},{"fact_id":"5bfc56bee514fffce5d1b36b","field":"drug.marketing_status","entity":"application:NDA022264"},{"fact_id":"0a9a0306a3baa87b3a89932c","field":"drug.partd_spending","entity":"drug:paliperidone-palmitate|invega-sustenna"},{"fact_id":"a8e9150e42eb5f1b922072c3","field":"drug.partd_spending","entity":"drug:paliperidone-palmitate|invega-sustenna"},{"fact_id":"a462b414e209d30799946f87","field":"drug.partd_spending","entity":"drug:paliperidone-palmitate|invega-sustenna"},{"fact_id":"33ea742a0f6c2776a1ee951c","field":"drug.partd_spending","entity":"drug:paliperidone-palmitate|invega-sustenna"},{"fact_id":"26805f1096572c814964571d","field":"drug.partd_spending","entity":"drug:paliperidone-palmitate|invega-sustenna"},{"fact_id":"f3ba0bc946203fc4e509bc4d","field":"drug.asp_price","entity":"hcpcs:J2426"},{"fact_id":"cd3dd36a057aa279b98ffed8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50458056101:NC"},{"fact_id":"5a348a119cf1b35bd14f4924","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50458056101:OH"},{"fact_id":"7c99f5a070b3d573d919dbb4","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50458056101:KS"},{"fact_id":"279e3c70ea3f32cfa205defb","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50458056001:MD"},{"fact_id":"5fe22f98e4048482457bf8fe","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50458056001:NJ"},{"fact_id":"032a0112961aeee81ec2f880","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50458056001:MA"},{"fact_id":"abbf40e9a9f47b8c20c79297","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50458056001:HI"}],"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":"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."}