{"answer":{"query":"Ayvakit","resolved_as":"applications","packages":5,"applications":["NDA212608"],"identity":{"application_numbers":["NDA212608"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2020-01-09","latest":"2021-06-16","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA212608","date":"2042-03-08","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":"12060354","productNo":"001"},"latest_patent_expiry":"2042-03-08","latest_exclusivity_expiry":"2030-05-22","dated_barriers":45,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":8,"exclusivities_listed":4,"fact_id":"94ce64509a251b6b45c9fd9e"}],"label_history":{"events_total":6,"non_cmc_events":6,"counts_by_class":{"EFFICACY":4,"LABELING":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA212608","submission_no":21,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-10-16","documents":[{"type":"Label","date":"2026-10-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/212608s021lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-10-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/212608Orig1s021ltr.pdf","untrusted":true}}],"fact_id":"b3c1472ab6434995c2632a57"},{"application":"NDA212608","submission_no":20,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-11-08","documents":[{"type":"Label","date":"2024-11-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212608s020lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-11-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212608Orig1s020ltr.pdf","untrusted":true}}],"fact_id":"9f51c94cceb0c85e72b10c84"},{"application":"NDA212608","submission_no":13,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-05-22","documents":[{"type":"Label","date":"2023-05-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212608s013lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-05-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212608Orig1s013ltr.pdf","untrusted":true}}],"fact_id":"7bc9607af598d458045db0f3"},{"application":"NDA212608","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-03-09","documents":[{"type":"Letter","date":"2023-03-10","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212608Orig1s012ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-03-10","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212608s012lbl.pdf","untrusted":true}}],"fact_id":"a97488c1542054c34dd9ae98"},{"application":"NDA212608","submission_no":7,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-06-16","documents":[{"type":"Label","date":"2021-06-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212608s007lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-06-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212608Orig1s007ltr.pdf","untrusted":true}}],"fact_id":"4c42aab9fd144d23e5f6b247"}],"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":{"NOT_PROVIDED":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":"NDA212608","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"AYVAKIT","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"100MG","untrusted":true}},{"application":"NDA212608","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"AYVAKIT","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"200MG","untrusted":true}},{"application":"NDA212608","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"AYVAKIT","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"25MG","untrusted":true}},{"application":"NDA212608","product_no":"005","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"AYVAKIT","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}},{"application":"NDA212608","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"AYVAKIT","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"300MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Avapritinib","untrusted":true},"brand":{"text":"Ayvakit","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":6909824,"claims":181,"beneficiaries":44,"average_spending_per_claim_usd":38175.823204,"fact_id":"e3f0ee2310d3f74e5e4c438f"},{"year":2021,"gross_spending_usd":15536747.39,"claims":420,"beneficiaries":123,"average_spending_per_claim_usd":36992.25569,"fact_id":"9f91704c8ab425d39e39fbd8"},{"year":2022,"gross_spending_usd":32282508.81,"claims":880,"beneficiaries":156,"average_spending_per_claim_usd":36684.669102,"fact_id":"05b0ba010f6d6aa8904f1af9"},{"year":2023,"gross_spending_usd":55171737.04,"claims":1398,"beneficiaries":267,"average_spending_per_claim_usd":39464.761831,"fact_id":"bdef509a0142dce7e950fbf2"},{"year":2024,"gross_spending_usd":160026588.26,"claims":4023,"beneficiaries":547,"average_spending_per_claim_usd":39777.924002,"fact_id":"32a493745b5d86049324486d"}],"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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Each answer lists the facts it rests on."}