{"answer":{"query":"Evrysdi","resolved_as":"applications","packages":2,"applications":["NDA213535","NDA219285"],"identity":{"application_numbers":["NDA213535","NDA219285"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"POWDER, FOR SOLUTION","untrusted":true},{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2020-08-07","latest":"2025-02-11","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA213535","date":"2041-04-15","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":"12122789","productNo":"001"},"latest_patent_expiry":"2041-04-15","latest_exclusivity_expiry":"2029-05-27","dated_barriers":10,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":3,"fact_id":"32e2314c06a359696e08581d"},{"application":"NDA219285","date":"2041-04-15","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":"12122789","productNo":"001"},"latest_patent_expiry":"2041-04-15","latest_exclusivity_expiry":"2026-10-03","dated_barriers":7,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":6,"exclusivities_listed":1,"fact_id":"163b0d717303af54767b2c29"}],"label_history":{"events_total":16,"non_cmc_events":15,"counts_by_class":{"LABELING":11,"EFFICACY":4},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA213535","submission_no":18,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-14","documents":[{"type":"Letter","date":"2026-09-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213535Orig1s018, 219285Orig1s003ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213535s018lbl.pdf","untrusted":true}}],"fact_id":"ef9c245df86f6f7cc7062a17"},{"application":"NDA219285","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-14","documents":[{"type":"Letter","date":"2026-09-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213535Orig1s018, 219285Orig1s003ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/219285s003lblUpdated.pdf","untrusted":true}}],"fact_id":"6e75d5a546bde2cf13fe1996"},{"application":"NDA213535","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-02-10","documents":[{"type":"Label","date":"2026-02-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213535Orig1s017;219285Orig1s002correctedlbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-02-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213535Orig1s017;219285Orig1s002correctedltr.pdf","untrusted":true}}],"fact_id":"f186a7cdb211f2f05f134679"},{"application":"NDA219285","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-02-10","documents":[{"type":"Letter","date":"2026-02-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213535Orig1s017;219285Orig1s002correctedltr.pdf","untrusted":true}},{"type":"Label","date":"2026-02-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213535Orig1s017;219285Orig1s002correctedlbl.pdf","untrusted":true}}],"fact_id":"47d0881237809d7c8be02a34"},{"application":"NDA213535","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-01-21","documents":[{"type":"Label","date":"2026-09-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213535s016lbl.pdf","untrusted":true}}],"fact_id":"cd3d1ea3c4aafece6b6914ae"}],"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":"NDA213535","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"EVRYSDI","untrusted":true},"form":{"text":"FOR SOLUTION;ORAL","untrusted":true},"strength":{"text":"0.75MG/ML","untrusted":true}},{"application":"NDA219285","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"EVRYSDI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"5MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Risdiplam","untrusted":true},"brand":{"text":"Evrysdi","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":15161292.24,"claims":566,"beneficiaries":185,"average_spending_per_claim_usd":26786.735406,"fact_id":"d8c0cdf4fc18a589291485ff"},{"year":2021,"gross_spending_usd":91959281.57,"claims":3623,"beneficiaries":374,"average_spending_per_claim_usd":25382.081582,"fact_id":"b8df24f737169a10625b67dd"},{"year":2022,"gross_spending_usd":120799423.01,"claims":4680,"beneficiaries":416,"average_spending_per_claim_usd":25811.842524,"fact_id":"0077ca957d079d485c5182f5"},{"year":2023,"gross_spending_usd":132416369.36,"claims":4833,"beneficiaries":424,"average_spending_per_claim_usd":27398.379756,"fact_id":"5e7e6222ffebb1775d207357"},{"year":2024,"gross_spending_usd":154528771.76,"claims":5578,"beneficiaries":471,"average_spending_per_claim_usd":27703.257755,"fact_id":"4b4e0c004360b172dc61f131"}],"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":"risdiplam","untrusted":true},"designation_count":2,"approved_count":2,"recent":[{"designated":"2017-01-04","use":{"text":"Treatment of spinal muscular atrophy","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Genentech, Inc., a Member of the Roche Group","untrusted":true},"approved":true},{"designated":"2017-01-04","use":{"text":"Treatment of spinal muscular atrophy","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Genentech, Inc., a Member of the Roche Group","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"56bee934e254aabb75b1f3b5"}],"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":4,"all_states_medicaid_reimbursed_usd":11674102.18,"all_states_medicaid_paid_prescriptions":544,"top_states":[{"state":"MN","medicaid_paid_prescriptions":352,"medicaid_reimbursed_usd":8457793.73,"total_reimbursed_usd":8634482.88,"packages":1,"covers":"all_record_types","fact_id":"e01d84aeaa01e19a8f84e0aa"},{"state":"AR","medicaid_paid_prescriptions":84,"medicaid_reimbursed_usd":1978564.86,"total_reimbursed_usd":2057870.97,"packages":1,"covers":"fee_for_service_only","fact_id":"c9f144dad12854b61a856809"},{"state":"ME","medicaid_paid_prescriptions":56,"medicaid_reimbursed_usd":1237743.59,"total_reimbursed_usd":1237743.59,"packages":1,"covers":"all_record_types","fact_id":"34013be4b4ec7e87183bfeb0"},{"state":"DE","medicaid_paid_prescriptions":52,"medicaid_reimbursed_usd":0,"total_reimbursed_usd":0,"packages":1,"covers":"all_record_types","fact_id":"7d4565ada8b0081042fa369a"}],"unlabelled_state_code_xx":null,"built_from_facts":4,"facts_fee_for_service_only":1,"older_year_facts_not_used":37,"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":"ce096845b12d1a43f631978f","field":"ndc.listing","entity":"ndc:50242017507"},{"fact_id":"438c04e41264070ed22ed1cb","field":"ndc.listing","entity":"ndc:50242020201"},{"fact_id":"32e2314c06a359696e08581d","field":"drug.generic_entry_earliest","entity":"application:NDA213535"},{"fact_id":"c3c49c88274992fbbe9be1ab","field":"drug.patent","entity":"application:NDA213535"},{"fact_id":"414d5bf1b794552e78a0eaf0","field":"drug.exclusivity","entity":"application:NDA213535"},{"fact_id":"163b0d717303af54767b2c29","field":"drug.generic_entry_earliest","entity":"application:NDA219285"},{"fact_id":"021af33628b1bbe091df4ecb","field":"drug.patent","entity":"application:NDA219285"},{"fact_id":"cd5076d61045d24670315b29","field":"drug.exclusivity","entity":"application:NDA219285"},{"fact_id":"ef9c245df86f6f7cc7062a17","field":"drug.label_event","entity":"application:NDA213535"},{"fact_id":"6e75d5a546bde2cf13fe1996","field":"drug.label_event","entity":"application:NDA219285"},{"fact_id":"f186a7cdb211f2f05f134679","field":"drug.label_event","entity":"application:NDA213535"},{"fact_id":"47d0881237809d7c8be02a34","field":"drug.label_event","entity":"application:NDA219285"},{"fact_id":"cd3d1ea3c4aafece6b6914ae","field":"drug.label_event","entity":"application:NDA213535"},{"fact_id":"88a8f5c40dbd0ce9c1896f1e","field":"drug.marketing_status","entity":"application:NDA213535"},{"fact_id":"3403c69f25ad25be3760dc34","field":"drug.marketing_status","entity":"application:NDA219285"},{"fact_id":"d8c0cdf4fc18a589291485ff","field":"drug.partd_spending","entity":"drug:risdiplam|evrysdi"},{"fact_id":"b8df24f737169a10625b67dd","field":"drug.partd_spending","entity":"drug:risdiplam|evrysdi"},{"fact_id":"0077ca957d079d485c5182f5","field":"drug.partd_spending","entity":"drug:risdiplam|evrysdi"},{"fact_id":"5e7e6222ffebb1775d207357","field":"drug.partd_spending","entity":"drug:risdiplam|evrysdi"},{"fact_id":"4b4e0c004360b172dc61f131","field":"drug.partd_spending","entity":"drug:risdiplam|evrysdi"},{"fact_id":"56bee934e254aabb75b1f3b5","field":"drug.orphan_designation","entity":"drug:risdiplam"},{"fact_id":"e01d84aeaa01e19a8f84e0aa","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50242017507:MN"},{"fact_id":"c9f144dad12854b61a856809","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50242017507:AR"},{"fact_id":"34013be4b4ec7e87183bfeb0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50242017507:ME"},{"fact_id":"7d4565ada8b0081042fa369a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50242017507:DE"}],"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":"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."}