{"answer":{"query":"Caplyta","resolved_as":"applications","packages":6,"applications":["NDA209500"],"identity":{"application_numbers":["NDA209500"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2021-11-01","latest":"2023-06-01","packages_with_a_start_date":6}},"generic_entry":[{"application":"NDA209500","date":"2040-12-10","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":"11753419","productNo":"001"},"latest_patent_expiry":"2040-12-10","latest_exclusivity_expiry":"2029-04-24","dated_barriers":66,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":25,"exclusivities_listed":2,"fact_id":"9143bdbef69ad4c1f258ce2f"}],"label_history":{"events_total":7,"non_cmc_events":6,"counts_by_class":{"EFFICACY":4,"LABELING":1,"TYPE 1":1},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA209500","submission_no":17,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-04-24","documents":[{"type":"Letter","date":"2026-04-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/209500Orig1s017ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-04-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209500s017lbl.pdf","untrusted":true}}],"fact_id":"5f0c968ea37ad406d29f61d6"},{"application":"NDA209500","submission_no":16,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-11-05","documents":[{"type":"Letter","date":"2025-11-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209500Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-11-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209500s016lbl.pdf","untrusted":true}}],"fact_id":"7a881f162369f8aa0c536d77"},{"application":"NDA209500","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-06-28","documents":[{"type":"Letter","date":"2023-06-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209500Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-06-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209500s011lbl.pdf","untrusted":true}}],"fact_id":"691fbb8b14456efca78f9d0a"},{"application":"NDA209500","submission_no":6,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-12-17","documents":[{"type":"Label","date":"2021-12-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209500s005s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-12-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209500Orig1s005,s006ltr.pdf","untrusted":true}}],"fact_id":"de8ff7cb415a52066c512784"},{"application":"NDA209500","submission_no":5,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-12-17","documents":[{"type":"Label","date":"2021-12-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209500s005s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-12-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209500Orig1s005,s006ltr.pdf","untrusted":true}}],"fact_id":"722e569bbe5e027b225f1bc7"}],"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":"NDA209500","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"CAPLYTA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 42MG BASE","untrusted":true}},{"application":"NDA209500","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"CAPLYTA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 21MG BASE","untrusted":true}},{"application":"NDA209500","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"CAPLYTA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 10.5MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Lumateperone Tosylate","untrusted":true},"brand":{"text":"Caplyta","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":12480688.32,"claims":9420,"beneficiaries":3291,"average_spending_per_claim_usd":1324.9138344,"fact_id":"8cd80567ad3185e943a07b0b"},{"year":2021,"gross_spending_usd":47511497.85,"claims":33590,"beneficiaries":7180,"average_spending_per_claim_usd":1414.4536425,"fact_id":"96db61b3c87e15280d35d99b"},{"year":2022,"gross_spending_usd":108476659.61,"claims":71081,"beneficiaries":15541,"average_spending_per_claim_usd":1526.0992334,"fact_id":"393f1aef635482a0148415ec"},{"year":2023,"gross_spending_usd":194921427.14,"claims":118753,"beneficiaries":21724,"average_spending_per_claim_usd":1641.40213,"fact_id":"8aba9a5129c574bbff60a7fe"},{"year":2024,"gross_spending_usd":268479293.41,"claims":159224,"beneficiaries":27010,"average_spending_per_claim_usd":1686.1735254,"fact_id":"3c33e7bf3c533c00745fb064"}],"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":12,"all_states_medicaid_reimbursed_usd":1627442.9,"all_states_medicaid_paid_prescriptions":1034,"top_states":[{"state":"GA","medicaid_paid_prescriptions":125,"medicaid_reimbursed_usd":201030.28,"total_reimbursed_usd":201845.46,"packages":1,"covers":"fee_for_service_only","fact_id":"f51830a0ba00a4e2228051c2"},{"state":"UT","medicaid_paid_prescriptions":115,"medicaid_reimbursed_usd":193984.97,"total_reimbursed_usd":195546.33,"packages":1,"covers":"all_record_types","fact_id":"29a6ff023a00710a2ef74980"},{"state":"NE","medicaid_paid_prescriptions":128,"medicaid_reimbursed_usd":189662.39,"total_reimbursed_usd":197292.35,"packages":1,"covers":"all_record_types","fact_id":"51ec291741c88be2aaf2667b"},{"state":"MT","medicaid_paid_prescriptions":102,"medicaid_reimbursed_usd":170122.28,"total_reimbursed_usd":170122.28,"packages":1,"covers":"all_record_types","fact_id":"612cbac47efae78e605f7f42"},{"state":"MA","medicaid_paid_prescriptions":104,"medicaid_reimbursed_usd":153609.81,"total_reimbursed_usd":153609.81,"packages":1,"covers":"fee_for_service_only","fact_id":"e9a602b817c18ccd66ed39ca"},{"state":"VT","medicaid_paid_prescriptions":79,"medicaid_reimbursed_usd":143154.95,"total_reimbursed_usd":143154.95,"packages":1,"covers":"all_record_types","fact_id":"28b9def30a3409a9e38e5ed5"},{"state":"AK","medicaid_paid_prescriptions":69,"medicaid_reimbursed_usd":118299.95,"total_reimbursed_usd":125801.82,"packages":1,"covers":"fee_for_service_only","fact_id":"3e25dfd837497c05b23cddaf"},{"state":"MD","medicaid_paid_prescriptions":70,"medicaid_reimbursed_usd":111500.89,"total_reimbursed_usd":111692.89,"packages":1,"covers":"all_record_types","fact_id":"1e627c4eaef774bd329d9694"},{"state":"SD","medicaid_paid_prescriptions":69,"medicaid_reimbursed_usd":109634.37,"total_reimbursed_usd":110706.63,"packages":1,"covers":"all_record_types","fact_id":"7dcfab9b895ff52321e6e9d3"},{"state":"HI","medicaid_paid_prescriptions":57,"medicaid_reimbursed_usd":103264.04,"total_reimbursed_usd":103264.04,"packages":1,"covers":"all_record_types","fact_id":"3badc682dbff1ac7e874d78b"}],"unlabelled_state_code_xx":null,"built_from_facts":12,"facts_fee_for_service_only":4,"older_year_facts_not_used":124,"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":"2ea7afe78c69274bdb702dc7","field":"ndc.listing","entity":"ndc:72060011007"},{"fact_id":"1c8ac17d650989eb10e221a4","field":"ndc.listing","entity":"ndc:72060011040"},{"fact_id":"5bb991ed616c3be6b74b3ee5","field":"ndc.listing","entity":"ndc:72060012107"},{"fact_id":"9143bdbef69ad4c1f258ce2f","field":"drug.generic_entry_earliest","entity":"application:NDA209500"},{"fact_id":"676ebb75af1470d2805a0ce5","field":"drug.patent","entity":"application:NDA209500"},{"fact_id":"8c20b40c8bb06dc03a56897d","field":"drug.exclusivity","entity":"application:NDA209500"},{"fact_id":"5f0c968ea37ad406d29f61d6","field":"drug.label_event","entity":"application:NDA209500"},{"fact_id":"7a881f162369f8aa0c536d77","field":"drug.label_event","entity":"application:NDA209500"},{"fact_id":"691fbb8b14456efca78f9d0a","field":"drug.label_event","entity":"application:NDA209500"},{"fact_id":"de8ff7cb415a52066c512784","field":"drug.label_event","entity":"application:NDA209500"},{"fact_id":"722e569bbe5e027b225f1bc7","field":"drug.label_event","entity":"application:NDA209500"},{"fact_id":"eb239cc763330307596e0e1e","field":"drug.marketing_status","entity":"application:NDA209500"},{"fact_id":"919aebeaa4e5335ed6f14e03","field":"drug.marketing_status","entity":"application:NDA209500"},{"fact_id":"469b12ca94a307d3210e2c40","field":"drug.marketing_status","entity":"application:NDA209500"},{"fact_id":"8cd80567ad3185e943a07b0b","field":"drug.partd_spending","entity":"drug:lumateperone-tosylate|caplyta"},{"fact_id":"96db61b3c87e15280d35d99b","field":"drug.partd_spending","entity":"drug:lumateperone-tosylate|caplyta"},{"fact_id":"393f1aef635482a0148415ec","field":"drug.partd_spending","entity":"drug:lumateperone-tosylate|caplyta"},{"fact_id":"8aba9a5129c574bbff60a7fe","field":"drug.partd_spending","entity":"drug:lumateperone-tosylate|caplyta"},{"fact_id":"3c33e7bf3c533c00745fb064","field":"drug.partd_spending","entity":"drug:lumateperone-tosylate|caplyta"},{"fact_id":"f51830a0ba00a4e2228051c2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72060011040:GA"},{"fact_id":"29a6ff023a00710a2ef74980","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72060011040:UT"},{"fact_id":"51ec291741c88be2aaf2667b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72060011040:NE"},{"fact_id":"612cbac47efae78e605f7f42","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72060012140:MT"},{"fact_id":"e9a602b817c18ccd66ed39ca","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72060011040:MA"},{"fact_id":"28b9def30a3409a9e38e5ed5","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72060014240:VT"},{"fact_id":"3e25dfd837497c05b23cddaf","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72060011040:AK"},{"fact_id":"1e627c4eaef774bd329d9694","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72060011040:MD"},{"fact_id":"7dcfab9b895ff52321e6e9d3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72060011040:SD"},{"fact_id":"3badc682dbff1ac7e874d78b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72060012140: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":"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."}