{"answer":{"query":"Epidiolex","resolved_as":"applications","packages":2,"applications":["NDA210365"],"identity":{"application_numbers":["NDA210365"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2018-10-05","latest":"2021-10-06","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA210365","date":"2042-09-24","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":"12661365","productNo":"001"},"latest_patent_expiry":"2042-09-24","latest_exclusivity_expiry":"2027-07-31","dated_barriers":36,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":33,"exclusivities_listed":3,"fact_id":"4c1b95194d8c1a3fa4aad10c"}],"label_history":{"events_total":16,"non_cmc_events":14,"counts_by_class":{"LABELING":11,"EFFICACY":3},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA210365","submission_no":30,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-05","documents":[{"type":"Letter","date":"2026-06-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/210365s024; 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s029;s030ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/210365s024s029s030lbl.pdf","untrusted":true}}],"fact_id":"50fe6a404f7ade46beda82bb"},{"application":"NDA210365","submission_no":23,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-26","documents":[{"type":"Letter","date":"2025-06-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210365Orig1s023ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-06-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210365s023lbl.pdf","untrusted":true}}],"fact_id":"049b637754c450e7a174d3f6"},{"application":"NDA210365","submission_no":21,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-03-04","documents":[{"type":"Letter","date":"2024-03-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210365Orig1s021ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-03-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210365s021lbl.pdf","untrusted":true}}],"fact_id":"89db606b445ad3d2fb9b3651"}],"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":"NDA210365","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"EPIDIOLEX","untrusted":true},"form":{"text":"SOLUTION;ORAL","untrusted":true},"strength":{"text":"100MG/ML","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Cannabidiol (Cbd)","untrusted":true},"brand":{"text":"Epidiolex","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":106979035.49,"claims":29682,"beneficiaries":3313,"average_spending_per_claim_usd":3604.1720736,"fact_id":"c1eac265dd501627e77a5d48"},{"year":2021,"gross_spending_usd":140129330.39,"claims":34131,"beneficiaries":3676,"average_spending_per_claim_usd":4105.6321347,"fact_id":"83c2301550ad36474f1dec1a"},{"year":2022,"gross_spending_usd":173788784.55,"claims":38152,"beneficiaries":3976,"average_spending_per_claim_usd":4555.1683935,"fact_id":"e555840b1758a573e775b251"},{"year":2023,"gross_spending_usd":197357912.19,"claims":41012,"beneficiaries":4236,"average_spending_per_claim_usd":4812.1991659,"fact_id":"ef7807be8bef008c4da513c3"},{"year":2024,"gross_spending_usd":207443287.44,"claims":43893,"beneficiaries":4517,"average_spending_per_claim_usd":4726.1132171,"fact_id":"d43acc22ffd263969eb42534"}],"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":"Cannabidiol; cannabidiol","untrusted":true},"designation_count":30,"approved_count":5,"recent":[{"designated":"2025-08-02","use":{"text":"treatment of malignant glioma","untrusted":true},"status":"Designated","sponsor":{"text":"Medicinal Cannabis of Georgia","untrusted":true},"approved":false},{"designated":"2024-02-14","use":{"text":"Treatment of pericarditis.","untrusted":true},"status":"Designated","sponsor":{"text":"Cardiol Therapeutics Inc.","untrusted":true},"approved":false},{"designated":"2022-12-12","use":{"text":"Treatment of Glioblastoma","untrusted":true},"status":"Designated","sponsor":{"text":"Transpire Bio Inc.","untrusted":true},"approved":false},{"designated":"2022-02-10","use":{"text":"Treatment of chromosome 15q11.2-13.1 duplication syndrome (dup15q)","untrusted":true},"status":"Designated","sponsor":{"text":"Benuvia Operations LLC","untrusted":true},"approved":false},{"designated":"2022-02-09","use":{"text":"Treatment of Angelman Syndrome","untrusted":true},"status":"Designated","sponsor":{"text":"Benuvia Operations LLC","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"10c294658c94d4286844d985"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; 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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":"417e384cc2f9d305f525700f","field":"ndc.listing","entity":"ndc:70127010010"},{"fact_id":"741d6571436664d09fbe17a3","field":"ndc.listing","entity":"ndc:70127010060"},{"fact_id":"4c1b95194d8c1a3fa4aad10c","field":"drug.generic_entry_earliest","entity":"application:NDA210365"},{"fact_id":"dfd7df016dfb8f3197c74375","field":"drug.patent","entity":"application:NDA210365"},{"fact_id":"e7033b15e48827b691035c05","field":"drug.exclusivity","entity":"application:NDA210365"},{"fact_id":"10f39522626189d0dba67e5e","field":"drug.label_event","entity":"application:NDA210365"},{"fact_id":"6d7608770ac6aa247bdfd924","field":"drug.label_event","entity":"application:NDA210365"},{"fact_id":"50fe6a404f7ade46beda82bb","field":"drug.label_event","entity":"application:NDA210365"},{"fact_id":"049b637754c450e7a174d3f6","field":"drug.label_event","entity":"application:NDA210365"},{"fact_id":"89db606b445ad3d2fb9b3651","field":"drug.label_event","entity":"application:NDA210365"},{"fact_id":"a2ba18334c18101b9aaa398f","field":"drug.marketing_status","entity":"application:NDA210365"},{"fact_id":"c1eac265dd501627e77a5d48","field":"drug.partd_spending","entity":"drug:cannabidiol-cbd|epidiolex"},{"fact_id":"83c2301550ad36474f1dec1a","field":"drug.partd_spending","entity":"drug:cannabidiol-cbd|epidiolex"},{"fact_id":"e555840b1758a573e775b251","field":"drug.partd_spending","entity":"drug:cannabidiol-cbd|epidiolex"},{"fact_id":"ef7807be8bef008c4da513c3","field":"drug.partd_spending","entity":"drug:cannabidiol-cbd|epidiolex"},{"fact_id":"d43acc22ffd263969eb42534","field":"drug.partd_spending","entity":"drug:cannabidiol-cbd|epidiolex"},{"fact_id":"10c294658c94d4286844d985","field":"drug.orphan_designation","entity":"drug:cannabidiol"},{"fact_id":"1794b5d41a466b0e4a32b1ed","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70127010010:NH"}],"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."}