{"answer":{"query":"Tafinlar","resolved_as":"applications","packages":3,"applications":["NDA202806","NDA217514"],"identity":{"application_numbers":["NDA202806","NDA217514"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true},{"text":"TABLET, FOR SUSPENSION","untrusted":true}],"marketing_start":{"earliest":"2016-04-01","latest":"2023-03-16","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA202806","date":"2034-02-28","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":"10869869*PED","productNo":"001"},"latest_patent_expiry":"2034-02-28","latest_exclusivity_expiry":"2030-09-16","dated_barriers":32,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":6,"exclusivities_listed":4,"fact_id":"ff955eec8ce2b8e28ad7f11a"},{"application":"NDA217514","date":"2038-12-29","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":"11504333*PED","productNo":"001"},"latest_patent_expiry":"2038-12-29","latest_exclusivity_expiry":"2030-09-16","dated_barriers":12,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":4,"fact_id":"dc855f9a510e3355bb449382"}],"label_history":{"events_total":38,"non_cmc_events":36,"counts_by_class":{"LABELING":23,"EFFICACY":13},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA202806","submission_no":40,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-03-26","documents":[{"type":"Label","date":"2026-03-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/202806s40lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-03-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202806Orig1s040,217514Orig1s011ltr.pdf","untrusted":true}}],"fact_id":"262777cd4b356402b7893df4"},{"application":"NDA217514","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-03-26","documents":[{"type":"Letter","date":"2026-03-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202806Orig1s040,217514Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-04-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217514Orig1s011lbl.pdf","untrusted":true}}],"fact_id":"634edd704dd758563e0df21c"},{"application":"NDA202806","submission_no":38,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-04-07","documents":[{"type":"Label","date":"2025-04-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s038,217514s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-04-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202806Orig1s038_217514Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"11cf2043a06b0ca70ec9e93e"},{"application":"NDA217514","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-04-07","documents":[{"type":"Label","date":"2025-04-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s038,217514s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-04-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202806Orig1s038_217514Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"64d3d32a4c5bec22f02f8217"},{"application":"NDA202806","submission_no":37,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-19","documents":[{"type":"Label","date":"2025-03-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202806s037,217514s008lbl.pdf","untrusted":true}}],"fact_id":"406eca2ca041885b9cf01e97"}],"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":"NDA202806","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TAFINLAR","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 50MG BASE","untrusted":true}},{"application":"NDA202806","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TAFINLAR","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 75MG BASE","untrusted":true}},{"application":"NDA217514","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TAFINLAR","untrusted":true},"form":{"text":"TABLET, FOR SUSPENSION;ORAL","untrusted":true},"strength":{"text":"EQ 10MG BASE","untrusted":true}},{"application":"NDA217514","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TAFINLAR","untrusted":true},"form":{"text":"TABLET; ORAL SUSPENSION","untrusted":true},"strength":{"text":"10MG","untrusted":true}},{"application":"NDA217514","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TAFINLAR","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"75MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Dabrafenib Mesylate","untrusted":true},"brand":{"text":"Tafinlar","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":100077167.11,"claims":10003,"beneficiaries":1955,"average_spending_per_claim_usd":10004.715296,"fact_id":"ef38b6fda7163e3f162d3a99"},{"year":2021,"gross_spending_usd":117905873.26,"claims":11159,"beneficiaries":2088,"average_spending_per_claim_usd":10565.98918,"fact_id":"2be68ee6e7a19b2b3a1827de"},{"year":2022,"gross_spending_usd":137437665.34,"claims":12122,"beneficiaries":2171,"average_spending_per_claim_usd":11337.870429,"fact_id":"d5c5d5a8fa2fd5f4840a211f"},{"year":2023,"gross_spending_usd":146891649.98,"claims":11702,"beneficiaries":2120,"average_spending_per_claim_usd":12552.696119,"fact_id":"c47132fa52a4fb4241b3dbc4"},{"year":2024,"gross_spending_usd":173893215.25,"claims":13603,"beneficiaries":2440,"average_spending_per_claim_usd":12783.445949,"fact_id":"56d58380c42411da306a19ba"}],"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":"Dabrafenib; dabrafenib","untrusted":true},"designation_count":4,"approved_count":2,"recent":[{"designated":"2020-10-19","use":{"text":"treatment of Kabuki Syndrome","untrusted":true},"status":"Designated","sponsor":{"text":"Rescindo Therapeutics Inc.","untrusted":true},"approved":false},{"designated":"2016-02-08","use":{"text":"Treatment of malignant glioma with BRAF V600 mutation","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"approved":true},{"designated":"2014-10-20","use":{"text":"Treatment of patients with BRAF mutation positive non-small cell lung cancer","untrusted":true},"status":"Designated","sponsor":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"approved":false},{"designated":"2011-01-12","use":{"text":"Treatment BRAF V600 mutation positive Stage IIB through IV melanoma","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novartis Pharmaceuticals Corp.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"0702b90aa79e6fdb61523243"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":7,"all_states_medicaid_reimbursed_usd":6929609.75,"all_states_medicaid_paid_prescriptions":584,"top_states":[{"state":"IL","medicaid_paid_prescriptions":105,"medicaid_reimbursed_usd":1532847.34,"total_reimbursed_usd":1532847.34,"packages":1,"covers":"fee_for_service_only","fact_id":"ed53ce7d591223c888d8ea95"},{"state":"CA","medicaid_paid_prescriptions":127,"medicaid_reimbursed_usd":1075489.47,"total_reimbursed_usd":1075489.47,"packages":1,"covers":"all_record_types","fact_id":"d8a3f78b8b9ba881b89c2337"},{"state":"CT","medicaid_paid_prescriptions":70,"medicaid_reimbursed_usd":1056857.9,"total_reimbursed_usd":1056857.9,"packages":1,"covers":"all_record_types","fact_id":"e2916396c9a0cb6a3fef7fd2"},{"state":"PR","medicaid_paid_prescriptions":67,"medicaid_reimbursed_usd":965059.71,"total_reimbursed_usd":993529.52,"packages":1,"covers":"all_record_types","fact_id":"c550b923d99e0d49b0837b15"},{"state":"VA","medicaid_paid_prescriptions":64,"medicaid_reimbursed_usd":843693.36,"total_reimbursed_usd":859431.87,"packages":1,"covers":"fee_for_service_only","fact_id":"a4cefb3aa9389efda382711d"},{"state":"TX","medicaid_paid_prescriptions":63,"medicaid_reimbursed_usd":837103.54,"total_reimbursed_usd":890966.73,"packages":1,"covers":"fee_for_service_only","fact_id":"ee2d449a9ae4977b8d448f2b"},{"state":"NY","medicaid_paid_prescriptions":88,"medicaid_reimbursed_usd":618558.43,"total_reimbursed_usd":618558.43,"packages":1,"covers":"all_record_types","fact_id":"03268a27f841258baa1bb09f"}],"unlabelled_state_code_xx":null,"built_from_facts":7,"facts_fee_for_service_only":3,"older_year_facts_not_used":22,"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":"66b29105a06645bf105b2df2","field":"ndc.listing","entity":"ndc:00078068166"},{"fact_id":"3b3d3d98e7e9455bc1a8beeb","field":"ndc.listing","entity":"ndc:00078068266"},{"fact_id":"13487216b151b5134b96662d","field":"ndc.listing","entity":"ndc:00078115421"},{"fact_id":"ff955eec8ce2b8e28ad7f11a","field":"drug.generic_entry_earliest","entity":"application:NDA202806"},{"fact_id":"828ab7c3f0e79efe80969f0c","field":"drug.patent","entity":"application:NDA202806"},{"fact_id":"faecf650053ed6834b060151","field":"drug.exclusivity","entity":"application:NDA202806"},{"fact_id":"dc855f9a510e3355bb449382","field":"drug.generic_entry_earliest","entity":"application:NDA217514"},{"fact_id":"86a1a41809bd754850b2db9e","field":"drug.patent","entity":"application:NDA217514"},{"fact_id":"7dcfbc856c7813a26afcca6b","field":"drug.exclusivity","entity":"application:NDA217514"},{"fact_id":"262777cd4b356402b7893df4","field":"drug.label_event","entity":"application:NDA202806"},{"fact_id":"634edd704dd758563e0df21c","field":"drug.label_event","entity":"application:NDA217514"},{"fact_id":"11cf2043a06b0ca70ec9e93e","field":"drug.label_event","entity":"application:NDA202806"},{"fact_id":"64d3d32a4c5bec22f02f8217","field":"drug.label_event","entity":"application:NDA217514"},{"fact_id":"406eca2ca041885b9cf01e97","field":"drug.label_event","entity":"application:NDA202806"},{"fact_id":"d75a93e97caed453453f5550","field":"drug.marketing_status","entity":"application:NDA202806"},{"fact_id":"4c9359724c13b6c4d4dd50ab","field":"drug.marketing_status","entity":"application:NDA202806"},{"fact_id":"e55edf4a876af9d7c349347f","field":"drug.marketing_status","entity":"application:NDA217514"},{"fact_id":"626d7d9814175176821c2045","field":"drug.marketing_status","entity":"application:NDA217514"},{"fact_id":"55134c90c81170aab3097639","field":"drug.marketing_status","entity":"application:NDA217514"},{"fact_id":"ef38b6fda7163e3f162d3a99","field":"drug.partd_spending","entity":"drug:dabrafenib-mesylate|tafinlar"},{"fact_id":"2be68ee6e7a19b2b3a1827de","field":"drug.partd_spending","entity":"drug:dabrafenib-mesylate|tafinlar"},{"fact_id":"d5c5d5a8fa2fd5f4840a211f","field":"drug.partd_spending","entity":"drug:dabrafenib-mesylate|tafinlar"},{"fact_id":"c47132fa52a4fb4241b3dbc4","field":"drug.partd_spending","entity":"drug:dabrafenib-mesylate|tafinlar"},{"fact_id":"56d58380c42411da306a19ba","field":"drug.partd_spending","entity":"drug:dabrafenib-mesylate|tafinlar"},{"fact_id":"0702b90aa79e6fdb61523243","field":"drug.orphan_designation","entity":"drug:dabrafenib"},{"fact_id":"ed53ce7d591223c888d8ea95","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078068166:IL"},{"fact_id":"d8a3f78b8b9ba881b89c2337","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078115421:CA"},{"fact_id":"e2916396c9a0cb6a3fef7fd2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078068166:CT"},{"fact_id":"c550b923d99e0d49b0837b15","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078068166:PR"},{"fact_id":"a4cefb3aa9389efda382711d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078068166:VA"},{"fact_id":"ee2d449a9ae4977b8d448f2b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078068166:TX"},{"fact_id":"03268a27f841258baa1bb09f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078115421:NY"}],"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."}