{"answer":{"query":"Tukysa","resolved_as":"applications","packages":3,"applications":["NDA213411"],"identity":{"application_numbers":["NDA213411"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2020-04-17","latest":"2020-04-17","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA213411","date":"2038-04-27","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":"11207324","productNo":"001"},"latest_patent_expiry":"2038-04-27","latest_exclusivity_expiry":"2030-01-19","dated_barriers":20,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":3,"fact_id":"39b97f237dc6646fc461851e"}],"label_history":{"events_total":2,"non_cmc_events":2,"counts_by_class":{"EFFICACY":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA213411","submission_no":10,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-10-07","documents":[{"type":"Letter","date":"2026-10-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213411Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-10-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213411s010lbl.pdf","untrusted":true}}],"fact_id":"4b641d9ff1c331725ab8411a"},{"application":"NDA213411","submission_no":4,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-01-19","documents":[{"type":"Label","date":"2023-01-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213411s004lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-01-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213411Orig1s004ltr.pdf","untrusted":true}}],"fact_id":"ccc732729862c57ff15a3cf5"}],"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":"NDA213411","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TUKYSA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}},{"application":"NDA213411","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TUKYSA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"150MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Tucatinib","untrusted":true},"brand":{"text":"Tukysa","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":30675582.48,"claims":1821,"beneficiaries":531,"average_spending_per_claim_usd":16845.459901,"fact_id":"6507d0a1bd227bedc7c4596c"},{"year":2021,"gross_spending_usd":81591015.41,"claims":4657,"beneficiaries":941,"average_spending_per_claim_usd":17520.080612,"fact_id":"3b555832085c9659b1514ab5"},{"year":2022,"gross_spending_usd":91179471.02,"claims":4812,"beneficiaries":906,"average_spending_per_claim_usd":18948.352249,"fact_id":"f68034bcf5d18daf12a9f342"},{"year":2023,"gross_spending_usd":102384647.14,"claims":4891,"beneficiaries":936,"average_spending_per_claim_usd":20933.274819,"fact_id":"1e25c2568667033daa2cd909"},{"year":2024,"gross_spending_usd":139353829.59,"claims":6463,"beneficiaries":1182,"average_spending_per_claim_usd":21561.787032,"fact_id":"50281b20dc43d807fba36aa5"}],"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; 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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":"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."}