{"answer":{"query":"Radicava Ors","resolved_as":"applications","packages":2,"applications":["NDA215446"],"identity":{"application_numbers":["NDA215446"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2022-05-12","latest":"2022-05-12","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA215446","date":"2041-11-12","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":"12194025","productNo":"001"},"latest_patent_expiry":"2041-11-12","latest_exclusivity_expiry":"2029-05-12","dated_barriers":13,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":12,"exclusivities_listed":1,"fact_id":"b99f18528b4fba8c8ced20af"}],"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":"NDA215446","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"RADICAVA ORS","untrusted":true},"form":{"text":"SUSPENSION;ORAL","untrusted":true},"strength":{"text":"105MG/5ML","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Edaravone","untrusted":true},"brand":{"text":"Radicava Ors","untrusted":true}},"latest_year":2024,"series":[{"year":2022,"gross_spending_usd":88869916.45,"claims":6240,"beneficiaries":1580,"average_spending_per_claim_usd":14241.97379,"fact_id":"18dedbcc6889357638952f4b"},{"year":2023,"gross_spending_usd":293678844.16,"claims":20981,"beneficiaries":2994,"average_spending_per_claim_usd":13997.371153,"fact_id":"1ba7749134eba30b82497df3"},{"year":2024,"gross_spending_usd":375705708.24,"claims":26703,"beneficiaries":3530,"average_spending_per_claim_usd":14069.793965,"fact_id":"4637079c38673669181a9f8b"}],"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":"edaravone","untrusted":true},"designation_count":4,"approved_count":2,"recent":[{"designated":"2021-11-04","use":{"text":"Treatment of Amyotrophic Lateral Sclerosis","untrusted":true},"status":"Designated","sponsor":{"text":"Shanghai Auzone Biological Technology Co., Ltd.","untrusted":true},"approved":false},{"designated":"2015-05-12","use":{"text":"Treatment of amyotrophic lateral sclerosis","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Tanabe Pharma America Inc.","untrusted":true},"approved":true},{"designated":"2015-05-12","use":{"text":"Treatment of amyotrophic lateral sclerosis","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Tanabe Pharma America Inc.","untrusted":true},"approved":true},{"designated":"2015-03-12","use":{"text":"Treatment of amyotrophic lateral sclerosis","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Treeway B.V.","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"c78f40be06e5ec78c5a0e27c"}],"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":3,"all_states_medicaid_reimbursed_usd":6799960.26,"all_states_medicaid_paid_prescriptions":499,"top_states":[{"state":"CA","medicaid_paid_prescriptions":300,"medicaid_reimbursed_usd":4104202.63,"total_reimbursed_usd":4104202.63,"packages":1,"covers":"all_record_types","fact_id":"d6c6badfd11e0991af0eac1c"},{"state":"NY","medicaid_paid_prescriptions":104,"medicaid_reimbursed_usd":1367105.29,"total_reimbursed_usd":1367105.29,"packages":1,"covers":"all_record_types","fact_id":"eae6c80c28ce23a5f884696e"},{"state":"PR","medicaid_paid_prescriptions":95,"medicaid_reimbursed_usd":1328652.34,"total_reimbursed_usd":1328652.34,"packages":1,"covers":"all_record_types","fact_id":"bc5b217d9acaaec790031bff"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":1259,"medicaid_reimbursed_usd":17117054.36,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":5,"facts_fee_for_service_only":1,"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":"69273b437820ee774d44fd71","field":"ndc.listing","entity":"ndc:70510232102"},{"fact_id":"2ed42764e35cdf298f54e294","field":"ndc.listing","entity":"ndc:70510232201"},{"fact_id":"b99f18528b4fba8c8ced20af","field":"drug.generic_entry_earliest","entity":"application:NDA215446"},{"fact_id":"66b7082a42c3abd3347e5753","field":"drug.patent","entity":"application:NDA215446"},{"fact_id":"07a5b1e9f0ea311f5dbdd198","field":"drug.exclusivity","entity":"application:NDA215446"},{"fact_id":"e22f7f1dae6f20cb478f5ed1","field":"drug.marketing_status","entity":"application:NDA215446"},{"fact_id":"18dedbcc6889357638952f4b","field":"drug.partd_spending","entity":"drug:edaravone|radicava-ors"},{"fact_id":"1ba7749134eba30b82497df3","field":"drug.partd_spending","entity":"drug:edaravone|radicava-ors"},{"fact_id":"4637079c38673669181a9f8b","field":"drug.partd_spending","entity":"drug:edaravone|radicava-ors"},{"fact_id":"c78f40be06e5ec78c5a0e27c","field":"drug.orphan_designation","entity":"drug:edaravone"},{"fact_id":"d6c6badfd11e0991af0eac1c","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70510232201:CA"},{"fact_id":"eae6c80c28ce23a5f884696e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70510232201:NY"},{"fact_id":"bc5b217d9acaaec790031bff","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70510232201:PR"}],"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":"label_history","reason":"no Drugs@FDA supplement recorded for these applications"},{"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."}