{"answer":{"query":"Braftovi","resolved_as":"applications","packages":4,"applications":["NDA210496"],"identity":{"application_numbers":["NDA210496"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2018-06-27","latest":"2020-08-03","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA210496","date":"2033-08-05","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":"9474754","productNo":"002"},"latest_patent_expiry":"2033-08-05","latest_exclusivity_expiry":"2030-10-11","dated_barriers":31,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":13,"exclusivities_listed":4,"fact_id":"306c1c6b037101019d30fda2"}],"label_history":{"events_total":11,"non_cmc_events":11,"counts_by_class":{"EFFICACY":9,"LABELING":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA210496","submission_no":21,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-02-24","documents":[{"type":"Label","date":"2026-02-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210496s021lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-03-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210496Orig1s021ltr.pdf","untrusted":true}}],"fact_id":"fc44662b4f3c686aba306a05"},{"application":"NDA210496","submission_no":19,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-02-24","documents":[{"type":"Label","date":"2026-02-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210496s019lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-03-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210496Orig1s019ltr.pdf","untrusted":true}}],"fact_id":"82e15329e7529b9f4f47b001"},{"application":"NDA210496","submission_no":18,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-03-12","documents":[{"type":"Letter","date":"2025-03-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210496Orig1s018ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-03-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210496s018lbl.pdf","untrusted":true}}],"fact_id":"2cdf6d1a4952c3822d2e774a"},{"application":"NDA210496","submission_no":17,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-12-20","documents":[{"type":"Label","date":"2024-12-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s017lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-12-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210496Orig1s017ltr.pdf","untrusted":true}}],"fact_id":"9badb406da5428e2b0783047"},{"application":"NDA210496","submission_no":16,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-09-12","documents":[{"type":"Label","date":"2024-09-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210496s016lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-09-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210496Orig1s016ltr.pdf","untrusted":true}}],"fact_id":"a5f265ee3f0151203f0209fb"}],"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":{"Discontinued":1,"Prescription":1},"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":"NDA210496","product_no":"001","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"BRAFTOVI","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}},{"application":"NDA210496","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"BRAFTOVI","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"75MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Encorafenib","untrusted":true},"brand":{"text":"Braftovi","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":55947004.78,"claims":4952,"beneficiaries":1170,"average_spending_per_claim_usd":11297.860416,"fact_id":"2ec4ef9f6f3bde4a0d6ee4f6"},{"year":2021,"gross_spending_usd":85249323.4,"claims":7043,"beneficiaries":1452,"average_spending_per_claim_usd":12104.120886,"fact_id":"d45eb949a7d15b86e7a2606c"},{"year":2022,"gross_spending_usd":100513429.58,"claims":7725,"beneficiaries":1527,"average_spending_per_claim_usd":13011.447195,"fact_id":"f11f18ae4bb0fa98872dad8d"},{"year":2023,"gross_spending_usd":87193015.83,"claims":6166,"beneficiaries":1328,"average_spending_per_claim_usd":14140.936722,"fact_id":"b9ddf19f4c9e2a1ccda9629d"},{"year":2024,"gross_spending_usd":138103680.02,"claims":9510,"beneficiaries":1872,"average_spending_per_claim_usd":14521.94322,"fact_id":"1d48d03a1250599c16bdda3d"}],"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}}},"orphan_designation":{"ingredients":[{"ingredient":{"text":"encorafenib","untrusted":true},"designation_count":2,"approved_count":1,"recent":[{"designated":"2021-09-08","use":{"text":"Treatment of BRAF-mutant Non-Small Cell Lung Cancer","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Array BioPharma Inc. 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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":"d9c1614170315367be562619","field":"ndc.listing","entity":"ndc:70255002501"},{"fact_id":"1abdebb0510f8ed7bff60010","field":"ndc.listing","entity":"ndc:70255002503"},{"fact_id":"6c60274dc31bf1495c15138d","field":"ndc.listing","entity":"ndc:70255002505"},{"fact_id":"306c1c6b037101019d30fda2","field":"drug.generic_entry_earliest","entity":"application:NDA210496"},{"fact_id":"e05a661d916972be74bcea1e","field":"drug.patent","entity":"application:NDA210496"},{"fact_id":"53575c4de5e20e5999c704e9","field":"drug.exclusivity","entity":"application:NDA210496"},{"fact_id":"fc44662b4f3c686aba306a05","field":"drug.label_event","entity":"application:NDA210496"},{"fact_id":"82e15329e7529b9f4f47b001","field":"drug.label_event","entity":"application:NDA210496"},{"fact_id":"2cdf6d1a4952c3822d2e774a","field":"drug.label_event","entity":"application:NDA210496"},{"fact_id":"9badb406da5428e2b0783047","field":"drug.label_event","entity":"application:NDA210496"},{"fact_id":"a5f265ee3f0151203f0209fb","field":"drug.label_event","entity":"application:NDA210496"},{"fact_id":"d556f1a3bae09c4773cf1d95","field":"drug.marketing_status","entity":"application:NDA210496"},{"fact_id":"bca048d6c24c1ad7266287b1","field":"drug.marketing_status","entity":"application:NDA210496"},{"fact_id":"2ec4ef9f6f3bde4a0d6ee4f6","field":"drug.partd_spending","entity":"drug:encorafenib|braftovi"},{"fact_id":"d45eb949a7d15b86e7a2606c","field":"drug.partd_spending","entity":"drug:encorafenib|braftovi"},{"fact_id":"f11f18ae4bb0fa98872dad8d","field":"drug.partd_spending","entity":"drug:encorafenib|braftovi"},{"fact_id":"b9ddf19f4c9e2a1ccda9629d","field":"drug.partd_spending","entity":"drug:encorafenib|braftovi"},{"fact_id":"1d48d03a1250599c16bdda3d","field":"drug.partd_spending","entity":"drug:encorafenib|braftovi"},{"fact_id":"c033b7e6dd5137aa37f5f4b9","field":"drug.orphan_designation","entity":"drug:encorafenib"},{"fact_id":"b8e1af3192ff68dd7e28a60a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70255002503:NY"},{"fact_id":"18f36c3d7db5600d0697a080","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70255002503:CA"},{"fact_id":"4b8d595a8238ea0d822d2f2a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70255002501:IL"},{"fact_id":"2ace2270a0a4055388905a91","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70255002503:NC"}],"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":"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."}