{"answer":{"query":"Fruzaqla","resolved_as":"applications","packages":2,"applications":["NDA217564"],"identity":{"application_numbers":["NDA217564"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2023-11-08","latest":"2023-11-08","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA217564","date":"2035-09-07","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":"10519142","productNo":"001"},"latest_patent_expiry":"2035-09-07","latest_exclusivity_expiry":"2028-11-08","dated_barriers":10,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":1,"fact_id":"951cadb63c0ea6b7bdf54db3"}],"label_history":{"events_total":1,"non_cmc_events":1,"counts_by_class":{"LABELING":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA217564","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-02-28","documents":[{"type":"Label","date":"2025-03-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/217564s002lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/217564Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"f0dd8375c9fa82c7f254a212"}],"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":"NDA217564","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"FRUZAQLA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"1MG","untrusted":true}},{"application":"NDA217564","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"FRUZAQLA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"5MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Fruquintinib","untrusted":true},"brand":{"text":"Fruzaqla","untrusted":true}},"latest_year":2024,"series":[{"year":2023,"gross_spending_usd":4562633.53,"claims":174,"beneficiaries":147,"average_spending_per_claim_usd":26222.031782,"fact_id":"72db9000d2543dbaad112227"},{"year":2024,"gross_spending_usd":137466500.32,"claims":5831,"beneficiaries":1935,"average_spending_per_claim_usd":23575.115815,"fact_id":"dc896ef672813d5c95838039"}],"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}}},"medicaid_state_utilization":{"year":2024,"states_with_data":2,"all_states_medicaid_reimbursed_usd":6148065.06,"all_states_medicaid_paid_prescriptions":247,"top_states":[{"state":"CA","medicaid_paid_prescriptions":163,"medicaid_reimbursed_usd":4087823.52,"total_reimbursed_usd":4109414.55,"packages":1,"covers":"all_record_types","fact_id":"8233122cdddae34f92b65c69"},{"state":"NY","medicaid_paid_prescriptions":84,"medicaid_reimbursed_usd":2060241.54,"total_reimbursed_usd":2060241.54,"packages":1,"covers":"all_record_types","fact_id":"8676006cab1475ab3239071b"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":1024,"medicaid_reimbursed_usd":24790018.02,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":4,"facts_fee_for_service_only":0,"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":"541e8ad6132441143d1e266f","field":"ndc.listing","entity":"ndc:63020021021"},{"fact_id":"f6937f9e3f237f08ba0d0ad1","field":"ndc.listing","entity":"ndc:63020022521"},{"fact_id":"951cadb63c0ea6b7bdf54db3","field":"drug.generic_entry_earliest","entity":"application:NDA217564"},{"fact_id":"095632b3ad7c4f05979d9edc","field":"drug.patent","entity":"application:NDA217564"},{"fact_id":"fdd903ea4edde7f05717be0f","field":"drug.exclusivity","entity":"application:NDA217564"},{"fact_id":"f0dd8375c9fa82c7f254a212","field":"drug.label_event","entity":"application:NDA217564"},{"fact_id":"56d1a40582fd7f3a21a2b460","field":"drug.marketing_status","entity":"application:NDA217564"},{"fact_id":"175cbabc150cb3dc46a1d502","field":"drug.marketing_status","entity":"application:NDA217564"},{"fact_id":"72db9000d2543dbaad112227","field":"drug.partd_spending","entity":"drug:fruquintinib|fruzaqla"},{"fact_id":"dc896ef672813d5c95838039","field":"drug.partd_spending","entity":"drug:fruquintinib|fruzaqla"},{"fact_id":"8233122cdddae34f92b65c69","field":"ndc.medicaid_state_utilization","entity":"ndc_state:63020022521:CA"},{"fact_id":"8676006cab1475ab3239071b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:63020022521: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":"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"}],"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."}