{"answer":{"query":"Fotivda","resolved_as":"applications","packages":2,"applications":["NDA212904"],"identity":{"application_numbers":["NDA212904"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2025-01-30","latest":"2025-01-30","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA212904","date":"2039-11-05","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":"11504365","productNo":"001"},"latest_patent_expiry":"2039-11-05","latest_exclusivity_expiry":"2026-03-10","dated_barriers":6,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":1,"fact_id":"ad22328ee651e7c4d077eaee"}],"label_history":{"events_total":2,"non_cmc_events":2,"counts_by_class":{"LABELING":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA212904","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-30","documents":[{"type":"Label","date":"2025-02-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212904s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212904Orig1s003ltr.pdf","untrusted":true}}],"fact_id":"0ac84053fdb0c87c41fd2d2f"},{"application":"NDA212904","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-06","documents":[{"type":"Letter","date":"2024-08-08","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212904Orig1s002ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-08-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212904s002lbl.pdf","untrusted":true}}],"fact_id":"f27aa542ab3c85eefd55da67"}],"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":{"Prescription":2},"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":"NDA212904","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"FOTIVDA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 0.89MG BASE","untrusted":true}},{"application":"NDA212904","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"FOTIVDA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 1.34MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Tivozanib HCl","untrusted":true},"brand":{"text":"Fotivda","untrusted":true}},"latest_year":2024,"series":[{"year":2021,"gross_spending_usd":22459910.48,"claims":906,"beneficiaries":304,"average_spending_per_claim_usd":24790.188168,"fact_id":"d216541dd6958894eb280271"},{"year":2022,"gross_spending_usd":72738997.68,"claims":2757,"beneficiaries":683,"average_spending_per_claim_usd":26383.386899,"fact_id":"286e1c320b82d28c451925a7"},{"year":2023,"gross_spending_usd":102301659.09,"claims":3638,"beneficiaries":923,"average_spending_per_claim_usd":28120.302114,"fact_id":"b7be4705f2bf9e0e28dcfb9f"},{"year":2024,"gross_spending_usd":118900828.62,"claims":4132,"beneficiaries":993,"average_spending_per_claim_usd":28775.61196,"fact_id":"c8a1b2268d7759579faf344c"}],"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}}}},"receipts":[{"fact_id":"3d87c2a513a59d08e553fcc0","field":"ndc.listing","entity":"ndc:45629008902"},{"fact_id":"ffadc91f16721a2187f4090d","field":"ndc.listing","entity":"ndc:45629013402"},{"fact_id":"ad22328ee651e7c4d077eaee","field":"drug.generic_entry_earliest","entity":"application:NDA212904"},{"fact_id":"8e0c550a5a43358bc8fe368b","field":"drug.patent","entity":"application:NDA212904"},{"fact_id":"e4a66c3b906b3d6e76327b93","field":"drug.exclusivity","entity":"application:NDA212904"},{"fact_id":"0ac84053fdb0c87c41fd2d2f","field":"drug.label_event","entity":"application:NDA212904"},{"fact_id":"f27aa542ab3c85eefd55da67","field":"drug.label_event","entity":"application:NDA212904"},{"fact_id":"d50121f868610cbddcd8b965","field":"drug.marketing_status","entity":"application:NDA212904"},{"fact_id":"2e6c0b182825725b9d2c1925","field":"drug.marketing_status","entity":"application:NDA212904"},{"fact_id":"d216541dd6958894eb280271","field":"drug.partd_spending","entity":"drug:tivozanib-hcl|fotivda"},{"fact_id":"286e1c320b82d28c451925a7","field":"drug.partd_spending","entity":"drug:tivozanib-hcl|fotivda"},{"fact_id":"b7be4705f2bf9e0e28dcfb9f","field":"drug.partd_spending","entity":"drug:tivozanib-hcl|fotivda"},{"fact_id":"c8a1b2268d7759579faf344c","field":"drug.partd_spending","entity":"drug:tivozanib-hcl|fotivda"}],"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":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"},{"code":"NO_DATA","field":"medicaid_state_utilization","reason":"no CMS State Drug Utilization figure for this drug's packages is in the edition (suppressed, out of scope or unreported)"}],"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."}