{"answer":{"query":"Tasigna","resolved_as":"applications","packages":5,"applications":["NDA022068"],"identity":{"application_numbers":["NDA022068"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2007-10-29","latest":"2018-03-22","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA022068","date":"2032-10-07","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":"9061029*PED","productNo":"003"},"latest_patent_expiry":"2032-10-07","latest_exclusivity_expiry":"2029-03-23","dated_barriers":42,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":6,"exclusivities_listed":2,"fact_id":"955d767fda8caff4d0aa6bb5"}],"label_history":{"events_total":33,"non_cmc_events":29,"counts_by_class":{"LABELING":18,"EFFICACY":10,"REMS":1},"cmc_events":4,"recent_non_cmc_events":[{"application":"NDA022068","submission_no":42,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-14","documents":[{"type":"Letter","date":"2024-08-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022068Orig1s042Corrected_ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-08-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068Orig1s042Corrected_lbl.pdf","untrusted":true}}],"fact_id":"0559330f12c8b73244b62cad"},{"application":"NDA022068","submission_no":41,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-02-08","documents":[{"type":"Letter","date":"2024-02-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022068Orig1s041Correctedltr.pdf","untrusted":true}},{"type":"Label","date":"2024-02-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022068s041lbl.pdf","untrusted":true}}],"fact_id":"ef52f1a5f62d49e84d92ebea"},{"application":"NDA022068","submission_no":36,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-09-23","documents":[{"type":"Label","date":"2021-09-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022068s035s036lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-09-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022068Orig1s035, 036ltr.pdf","untrusted":true}}],"fact_id":"b999e1d6721e83e92c1e85d0"},{"application":"NDA022068","submission_no":35,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-09-23","documents":[{"type":"Label","date":"2021-09-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022068s035s036lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-09-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022068Orig1s035, 036ltr.pdf","untrusted":true}}],"fact_id":"ec24710ff6b50e858474300f"},{"application":"NDA022068","submission_no":33,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-12-08","documents":[{"type":"Letter","date":"2020-12-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022068Orig1s033ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-12-10","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022068s033lbl.pdf","untrusted":true}}],"fact_id":"584445d9c6e69decf518124e"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"AB":3},"marketing_status_counts":{"Prescription":3},"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":"NDA022068","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TASIGNA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 50MG BASE","untrusted":true}},{"application":"NDA022068","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TASIGNA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 200MG BASE","untrusted":true}},{"application":"NDA022068","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TASIGNA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 150MG BASE","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":5,"most_recent":[{"recall_number":"D-0797-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"98f04fe6772cdc93e7b5c943"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Nilotinib HCl","untrusted":true},"brand":{"text":"Tasigna","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":339500199.22,"claims":26481,"beneficiaries":3148,"average_spending_per_claim_usd":12820.520344,"fact_id":"b1c101e583b36cb74f73f460"},{"year":2021,"gross_spending_usd":352216339.08,"claims":25986,"beneficiaries":3114,"average_spending_per_claim_usd":13554.080623,"fact_id":"73899e351ad0eb78842b4c86"},{"year":2022,"gross_spending_usd":375995128.36,"claims":25750,"beneficiaries":3024,"average_spending_per_claim_usd":14601.752558,"fact_id":"ab2c2c3791404f351ed34b99"},{"year":2023,"gross_spending_usd":394675625.23,"claims":24550,"beneficiaries":2961,"average_spending_per_claim_usd":16076.400213,"fact_id":"b2f1adf2b42d872afecf78a9"},{"year":2024,"gross_spending_usd":426961765.33,"claims":26420,"beneficiaries":3054,"average_spending_per_claim_usd":16160.551299,"fact_id":"5e2b85d144ce8763e413b9cd"}],"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}}},"rems":{"programs":[{"application":"NDA022068","program":{"text":"Tasigna","untrusted":true},"rems_id":"55","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":false,"program_date":"2010-03-15","last_modified":"2013-05-17","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=55","other_programs":0,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"445b97ab7b8b24014c112b81"}],"reading":"what the FDA REMS@FDA files tie to the application on the read date; it does not say which prescribers or pharmacies take part or whether a patient needs the program"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"Nilotinib; nilotinib","untrusted":true},"designation_count":7,"approved_count":5,"recent":[{"designated":"2025-04-10","use":{"text":"Treatment of Chronic Myelogenous Leukemia","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Azurity Pharmaceuticals, Inc.","untrusted":true},"approved":true},{"designated":"2020-12-23","use":{"text":"Treatment of Chronic Myeloid Leukemia","untrusted":true},"status":"Designated","sponsor":{"text":"Handa Oncology, LLC","untrusted":true},"approved":false},{"designated":"2020-05-28","use":{"text":"Treatment of chronic myelogenous leukemia","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Cycle Pharmaceuticals Ltd","untrusted":true},"approved":true},{"designated":"2007-03-20","use":{"text":"Treatment of gastrointestinal stromal tumors.","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Novartis Pharmaeuticals Corporation","untrusted":true},"approved":false},{"designated":"2006-04-27","use":{"text":"Treatment of chronic myelogenous leukemia","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"f40e5737e2a852a56fcb44c5"}],"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":2024,"states_with_data":17,"all_states_medicaid_reimbursed_usd":58296437.34,"all_states_medicaid_paid_prescriptions":3397,"top_states":[{"state":"CA","medicaid_paid_prescriptions":888,"medicaid_reimbursed_usd":15929182.37,"total_reimbursed_usd":16114377.02,"packages":2,"covers":"all_record_types","fact_id":"e395a10eb23f2b3bf8fb8124"},{"state":"NY","medicaid_paid_prescriptions":483,"medicaid_reimbursed_usd":8206294.88,"total_reimbursed_usd":8206294.88,"packages":2,"covers":"all_record_types","fact_id":"28f8c2066fe1f5c8abf67585"},{"state":"TX","medicaid_paid_prescriptions":243,"medicaid_reimbursed_usd":3864735.64,"total_reimbursed_usd":3864735.64,"packages":2,"covers":"fee_for_service_only","fact_id":"eb03dc9fc7ada941ddb917eb"},{"state":"PA","medicaid_paid_prescriptions":222,"medicaid_reimbursed_usd":3711961.3,"total_reimbursed_usd":3892030.56,"packages":2,"covers":"fee_for_service_only","fact_id":"c12c370da03208126a6fa7f1"},{"state":"OH","medicaid_paid_prescriptions":160,"medicaid_reimbursed_usd":3175429.74,"total_reimbursed_usd":3175429.74,"packages":1,"covers":"fee_for_service_only","fact_id":"ad5449940b01308bb236a708"},{"state":"AZ","medicaid_paid_prescriptions":179,"medicaid_reimbursed_usd":3036302.48,"total_reimbursed_usd":3212154.44,"packages":2,"covers":"fee_for_service_only","fact_id":"866f892e8527de42910c6446"},{"state":"MI","medicaid_paid_prescriptions":187,"medicaid_reimbursed_usd":3014507.71,"total_reimbursed_usd":3014507.71,"packages":2,"covers":"fee_for_service_only","fact_id":"2e4b7108562262f8dafb3ff9"},{"state":"FL","medicaid_paid_prescriptions":176,"medicaid_reimbursed_usd":2700744.69,"total_reimbursed_usd":2756066.22,"packages":2,"covers":"fee_for_service_only","fact_id":"6743d6848333b036d7d810d2"},{"state":"IL","medicaid_paid_prescriptions":140,"medicaid_reimbursed_usd":2428745.41,"total_reimbursed_usd":2428745.41,"packages":1,"covers":"all_record_types","fact_id":"79c2c8576c4f90a2303a27fe"},{"state":"VA","medicaid_paid_prescriptions":127,"medicaid_reimbursed_usd":2057645.27,"total_reimbursed_usd":2166924.51,"packages":1,"covers":"fee_for_service_only","fact_id":"e0b3d6f625485a5acd3e8026"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":5481,"medicaid_reimbursed_usd":91412954.71,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":28,"facts_fee_for_service_only":11,"older_year_facts_not_used":0,"dataset":"State Drug Utilization Data 2024","read_on":"2026-11-07T23:59:45.983Z","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":"945d4d3c90aef78d6e32d127","field":"ndc.listing","entity":"ndc:00078052651"},{"fact_id":"558afc66fc89a099c8769c2f","field":"ndc.listing","entity":"ndc:00078052687"},{"fact_id":"36b354919d8ba71242d3dd5a","field":"ndc.listing","entity":"ndc:00078059251"},{"fact_id":"955d767fda8caff4d0aa6bb5","field":"drug.generic_entry_earliest","entity":"application:NDA022068"},{"fact_id":"b01ceb4a373203861f3370ed","field":"drug.patent","entity":"application:NDA022068"},{"fact_id":"5ecc4917df21d83b45c93d0a","field":"drug.exclusivity","entity":"application:NDA022068"},{"fact_id":"0559330f12c8b73244b62cad","field":"drug.label_event","entity":"application:NDA022068"},{"fact_id":"ef52f1a5f62d49e84d92ebea","field":"drug.label_event","entity":"application:NDA022068"},{"fact_id":"b999e1d6721e83e92c1e85d0","field":"drug.label_event","entity":"application:NDA022068"},{"fact_id":"ec24710ff6b50e858474300f","field":"drug.label_event","entity":"application:NDA022068"},{"fact_id":"584445d9c6e69decf518124e","field":"drug.label_event","entity":"application:NDA022068"},{"fact_id":"ddc9599d0396b23d234ae190","field":"drug.te_code","entity":"application:NDA022068"},{"fact_id":"71248667a36d01f3a40ded7d","field":"drug.marketing_status","entity":"application:NDA022068"},{"fact_id":"7e6586116288eb08b4b64871","field":"drug.te_code","entity":"application:NDA022068"},{"fact_id":"bfebcbd3cc76bee29e60cf3e","field":"drug.marketing_status","entity":"application:NDA022068"},{"fact_id":"72138a4e33a7f1dd6fc1ccef","field":"drug.te_code","entity":"application:NDA022068"},{"fact_id":"2de3c6ad36097ccb0c7ad7e5","field":"drug.marketing_status","entity":"application:NDA022068"},{"fact_id":"98f04fe6772cdc93e7b5c943","field":"ndc.recall","entity":"ndc:00078059287"},{"fact_id":"b1c101e583b36cb74f73f460","field":"drug.partd_spending","entity":"drug:nilotinib-hcl|tasigna"},{"fact_id":"73899e351ad0eb78842b4c86","field":"drug.partd_spending","entity":"drug:nilotinib-hcl|tasigna"},{"fact_id":"ab2c2c3791404f351ed34b99","field":"drug.partd_spending","entity":"drug:nilotinib-hcl|tasigna"},{"fact_id":"b2f1adf2b42d872afecf78a9","field":"drug.partd_spending","entity":"drug:nilotinib-hcl|tasigna"},{"fact_id":"5e2b85d144ce8763e413b9cd","field":"drug.partd_spending","entity":"drug:nilotinib-hcl|tasigna"},{"fact_id":"445b97ab7b8b24014c112b81","field":"drug.rems","entity":"application:NDA022068"},{"fact_id":"f40e5737e2a852a56fcb44c5","field":"drug.orphan_designation","entity":"drug:nilotinib"},{"fact_id":"e395a10eb23f2b3bf8fb8124","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078059287:CA"},{"fact_id":"28f8c2066fe1f5c8abf67585","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078059287:NY"},{"fact_id":"eb03dc9fc7ada941ddb917eb","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078059287:TX"},{"fact_id":"c12c370da03208126a6fa7f1","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078059287:PA"},{"fact_id":"ad5449940b01308bb236a708","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078059287:OH"},{"fact_id":"866f892e8527de42910c6446","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078059287:AZ"},{"fact_id":"2e4b7108562262f8dafb3ff9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078059287:MI"},{"fact_id":"6743d6848333b036d7d810d2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078059287:FL"},{"fact_id":"79c2c8576c4f90a2303a27fe","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078059287:IL"},{"fact_id":"e0b3d6f625485a5acd3e8026","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078059287:VA"}],"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":"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":"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."}