{"answer":{"query":"Truqap","resolved_as":"applications","packages":6,"applications":["NDA218197"],"identity":{"application_numbers":["NDA218197"],"marketing_categories":["NDA"],"labelers":[{"text":"ASTRAZENECA PHARMACEUTICALS LP","untrusted":true}],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2023-11-16","latest":"2026-06-03","packages_with_a_start_date":6}},"generic_entry":[{"application":"NDA218197","date":"2033-04-16","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":"10039766","productNo":"001"},"latest_patent_expiry":"2033-04-16","latest_exclusivity_expiry":"2029-06-12","dated_barriers":22,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":9,"exclusivities_listed":2,"fact_id":"540c61e07c96bef6201d9532"}],"label_history":{"events_total":6,"non_cmc_events":6,"counts_by_class":{"EFFICACY":2,"LABELING":4},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA218197","submission_no":6,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-09-16","documents":[{"type":"Letter","date":"2026-09-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218197Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218197s006lbl.pdf","untrusted":true}}],"fact_id":"0878780a8eaf228536bcd9ac"},{"application":"NDA218197","submission_no":4,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-06-12","documents":[{"type":"Letter","date":"2026-06-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218197Orig1s004ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/218197s004lbl.pdf","untrusted":true}}],"fact_id":"53c0a2e781cecb8f62a8b007"},{"application":"NDA218197","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-05-27","documents":[{"type":"Letter","date":"2026-05-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/218197Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"fe7cc388901606959c45ecac"},{"application":"NDA218197","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-11-14","documents":[{"type":"Label","date":"2025-11-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218197s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-11-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218197Orig1s003ltr.pdf","untrusted":true}}],"fact_id":"da36628fab8fb3633d609447"},{"application":"NDA218197","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-02-13","documents":[{"type":"Letter","date":"2025-02-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/218197Orig1s002ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-02-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218197s002lbl.pdf","untrusted":true}}],"fact_id":"d0840ff490aa232dba7e2313"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":2},"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":"NDA218197","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TRUQAP","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"160MG","untrusted":true}},{"application":"NDA218197","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TRUQAP","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"200MG","untrusted":true}}]},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":1,"next_package_termination_dates":["2027-05-31"],"packages_with_future_termination_date":1,"termination_meaning":"manufacturer-reported last-lot expiry or withdrawal date of one package; other packages and generics can remain"},"spending":{"reported_under":{"generic":{"text":"Capivasertib","untrusted":true},"brand":{"text":"Truqap","untrusted":true}},"latest_year":2024,"series":[{"year":2023,"gross_spending_usd":1501469.74,"claims":61,"beneficiaries":56,"average_spending_per_claim_usd":24614.258033,"fact_id":"b65135f6bd1da307746ea446"},{"year":2024,"gross_spending_usd":184169025.72,"claims":8670,"beneficiaries":2247,"average_spending_per_claim_usd":21242.102159,"fact_id":"7c879aa2ab4df95ba8efb453"}],"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":3,"all_states_medicaid_reimbursed_usd":5741979.47,"all_states_medicaid_paid_prescriptions":273,"top_states":[{"state":"TX","medicaid_paid_prescriptions":130,"medicaid_reimbursed_usd":2613577.29,"total_reimbursed_usd":2613577.29,"packages":1,"covers":"all_record_types","fact_id":"bb9d38908baf88d5a2789c5b"},{"state":"PA","medicaid_paid_prescriptions":74,"medicaid_reimbursed_usd":1661955.32,"total_reimbursed_usd":1661955.32,"packages":1,"covers":"fee_for_service_only","fact_id":"8c221ea1b098ddcc5e9e7660"},{"state":"FL","medicaid_paid_prescriptions":69,"medicaid_reimbursed_usd":1466446.86,"total_reimbursed_usd":1466446.86,"packages":1,"covers":"fee_for_service_only","fact_id":"15e3649a63097e0033e535b8"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":698,"medicaid_reimbursed_usd":15599760.27,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":5,"facts_fee_for_service_only":2,"older_year_facts_not_used":4,"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":"d3b4b540349fb6942db1f044","field":"ndc.listing","entity":"ndc:00310950001"},{"fact_id":"617ddaeb643563e4d86cfc83","field":"ndc.listing","entity":"ndc:00310950002"},{"fact_id":"6f675c2e71fb7a617e8c27a1","field":"ndc.listing","entity":"ndc:00310950101"},{"fact_id":"540c61e07c96bef6201d9532","field":"drug.generic_entry_earliest","entity":"application:NDA218197"},{"fact_id":"84eb0a6837ac5761edd92127","field":"drug.patent","entity":"application:NDA218197"},{"fact_id":"82469106d8063849accc2707","field":"drug.exclusivity","entity":"application:NDA218197"},{"fact_id":"0878780a8eaf228536bcd9ac","field":"drug.label_event","entity":"application:NDA218197"},{"fact_id":"53c0a2e781cecb8f62a8b007","field":"drug.label_event","entity":"application:NDA218197"},{"fact_id":"fe7cc388901606959c45ecac","field":"drug.label_event","entity":"application:NDA218197"},{"fact_id":"da36628fab8fb3633d609447","field":"drug.label_event","entity":"application:NDA218197"},{"fact_id":"d0840ff490aa232dba7e2313","field":"drug.label_event","entity":"application:NDA218197"},{"fact_id":"c5c03ae5cc7d4d4e32f0ad04","field":"drug.marketing_status","entity":"application:NDA218197"},{"fact_id":"45f32d28166b64eddf24031d","field":"drug.marketing_status","entity":"application:NDA218197"},{"fact_id":"efa94408a1e57e245e343264","field":"ndc.product","entity":"ndc:00310950001"},{"fact_id":"b65135f6bd1da307746ea446","field":"drug.partd_spending","entity":"drug:capivasertib|truqap"},{"fact_id":"7c879aa2ab4df95ba8efb453","field":"drug.partd_spending","entity":"drug:capivasertib|truqap"},{"fact_id":"bb9d38908baf88d5a2789c5b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00310950101:TX"},{"fact_id":"8c221ea1b098ddcc5e9e7660","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00310950101:PA"},{"fact_id":"15e3649a63097e0033e535b8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00310950101:FL"}],"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":"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."}