{"answer":{"query":"Mektovi","resolved_as":"applications","packages":2,"applications":["NDA210498"],"identity":{"application_numbers":["NDA210498"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2018-06-27","latest":"2018-06-27","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA210498","date":"2033-10-18","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":"9562016","productNo":"001"},"latest_patent_expiry":"2033-10-18","latest_exclusivity_expiry":"2026-10-11","dated_barriers":8,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":1,"fact_id":"8613da67784dd7eec9fae857"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"EFFICACY":4},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA210498","submission_no":11,"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/2025/210498Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-03-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210498s011lbl.pdf","untrusted":true}}],"fact_id":"c7722e7f3bf0db81b5bd5674"},{"application":"NDA210498","submission_no":10,"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/2024/210498s010lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-09-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210498Orig1s010ltr.pdf","untrusted":true}}],"fact_id":"0e7e68b0ec9644cdd5af4de8"},{"application":"NDA210498","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-10-11","documents":[{"type":"Label","date":"2023-10-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210498s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-10-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210498Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"317aaa1482f1b808aed78a37"},{"application":"NDA210498","submission_no":1,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-01-23","documents":[{"type":"Label","date":"2019-01-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210498s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-02-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210498Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"9f5375943da5023d028bd62f"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"NOT_PROVIDED":1},"marketing_status_counts":{"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":"NDA210498","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"MEKTOVI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"15MG","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class III":1},"packages_of_these_applications":2,"most_recent":[{"recall_number":"D-0532-2023","classification":"Class III","status":"Ongoing","report_date":"2023-04-19","recall_initiated":"2023-03-08","recalling_firm":{"text":"Pfizer Inc.","untrusted":true},"reason":{"text":"Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.","untrusted":true},"packages_named":2,"fact_id":"dd88c7695da23270d5591160"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Binimetinib","untrusted":true},"brand":{"text":"Mektovi","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":48497192.84,"claims":4521,"beneficiaries":1023,"average_spending_per_claim_usd":10727.094192,"fact_id":"00f670527c237eddaa21a19a"},{"year":2021,"gross_spending_usd":64201142.63,"claims":5677,"beneficiaries":1107,"average_spending_per_claim_usd":11308.991127,"fact_id":"357cac40c24cd25ed2d9c10e"},{"year":2022,"gross_spending_usd":73003222.57,"claims":6133,"beneficiaries":1152,"average_spending_per_claim_usd":11903.346253,"fact_id":"1c28f62139291ac63c849b22"},{"year":2023,"gross_spending_usd":56654058.66,"claims":4381,"beneficiaries":875,"average_spending_per_claim_usd":12931.764131,"fact_id":"bc73d18b931a6932edf49db8"},{"year":2024,"gross_spending_usd":96181636.3,"claims":7307,"beneficiaries":1364,"average_spending_per_claim_usd":13162.944615,"fact_id":"234c96b2315e615698a225b2"}],"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":"binimetinib","untrusted":true},"designation_count":2,"approved_count":0,"recent":[{"designated":"2014-07-31","use":{"text":"Treatment of ovarian cancer","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Array BioPharma Inc., a wholly-owned subsidiary of Pfizer Inc.","untrusted":true},"approved":false},{"designated":"2013-11-19","use":{"text":"Treatment Stage IIB-IV melanoma.","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Array BioPharma Inc., a wholly-owned subsidiary of Pfizer Inc.","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"64b27eb90642cb1ecfad544a"}],"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":3,"all_states_medicaid_reimbursed_usd":2940397.19,"all_states_medicaid_paid_prescriptions":209,"top_states":[{"state":"NC","medicaid_paid_prescriptions":104,"medicaid_reimbursed_usd":1393335.03,"total_reimbursed_usd":1407310.27,"packages":1,"covers":"all_record_types","fact_id":"5799f79dc817815d06791f21"},{"state":"MA","medicaid_paid_prescriptions":52,"medicaid_reimbursed_usd":836656.16,"total_reimbursed_usd":836656.16,"packages":1,"covers":"fee_for_service_only","fact_id":"ab577f5fd6b1643db985f09a"},{"state":"AZ","medicaid_paid_prescriptions":53,"medicaid_reimbursed_usd":710406,"total_reimbursed_usd":746867.97,"packages":1,"covers":"all_record_types","fact_id":"37a29e7a8562e79edffe67f7"}],"unlabelled_state_code_xx":null,"built_from_facts":3,"facts_fee_for_service_only":1,"older_year_facts_not_used":10,"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":"a51adf1098aaee5ec2a59c68","field":"ndc.listing","entity":"ndc:70255001002"},{"fact_id":"24c03eb8bcbfa870289be733","field":"ndc.listing","entity":"ndc:70255001003"},{"fact_id":"8613da67784dd7eec9fae857","field":"drug.generic_entry_earliest","entity":"application:NDA210498"},{"fact_id":"e9f55c0e554d706b50ca9ad9","field":"drug.patent","entity":"application:NDA210498"},{"fact_id":"f6401020865bd5e2de0132d1","field":"drug.exclusivity","entity":"application:NDA210498"},{"fact_id":"c7722e7f3bf0db81b5bd5674","field":"drug.label_event","entity":"application:NDA210498"},{"fact_id":"0e7e68b0ec9644cdd5af4de8","field":"drug.label_event","entity":"application:NDA210498"},{"fact_id":"317aaa1482f1b808aed78a37","field":"drug.label_event","entity":"application:NDA210498"},{"fact_id":"9f5375943da5023d028bd62f","field":"drug.label_event","entity":"application:NDA210498"},{"fact_id":"75e8694ef4aab737f6df6eff","field":"drug.marketing_status","entity":"application:NDA210498"},{"fact_id":"dd88c7695da23270d5591160","field":"ndc.recall","entity":"ndc:70255001003"},{"fact_id":"00f670527c237eddaa21a19a","field":"drug.partd_spending","entity":"drug:binimetinib|mektovi"},{"fact_id":"357cac40c24cd25ed2d9c10e","field":"drug.partd_spending","entity":"drug:binimetinib|mektovi"},{"fact_id":"1c28f62139291ac63c849b22","field":"drug.partd_spending","entity":"drug:binimetinib|mektovi"},{"fact_id":"bc73d18b931a6932edf49db8","field":"drug.partd_spending","entity":"drug:binimetinib|mektovi"},{"fact_id":"234c96b2315e615698a225b2","field":"drug.partd_spending","entity":"drug:binimetinib|mektovi"},{"fact_id":"64b27eb90642cb1ecfad544a","field":"drug.orphan_designation","entity":"drug:binimetinib"},{"fact_id":"5799f79dc817815d06791f21","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70255001002:NC"},{"fact_id":"ab577f5fd6b1643db985f09a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70255001002:MA"},{"fact_id":"37a29e7a8562e79edffe67f7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70255001002:AZ"}],"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":"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."}