{"answer":{"query":"Xcopri","resolved_as":"applications","packages":12,"applications":["NDA212839"],"identity":{"application_numbers":["NDA212839"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true},{"text":"KIT","untrusted":true},{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2020-03-12","latest":"2025-08-29","packages_with_a_start_date":12}},"generic_entry":[{"application":"NDA212839","date":"2039-06-16","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":"11654133","productNo":"001"},"latest_patent_expiry":"2039-06-16","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":12,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":0,"fact_id":"c92d1c3101439d5552d8e98d"}],"label_history":{"events_total":7,"non_cmc_events":7,"counts_by_class":{"LABELING":7},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA212839","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-08-18","documents":[{"type":"Letter","date":"2025-08-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212839Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-08-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212839s013lbl.pdf","untrusted":true}}],"fact_id":"5826b5a49e9f490e88e7ff5c"},{"application":"NDA212839","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-04-05","documents":[{"type":"Letter","date":"2024-04-08","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212839Orig1s009, s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-04-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212839s009s010lbl.pdf","untrusted":true}}],"fact_id":"c169e46f4b66928f241c34e4"},{"application":"NDA212839","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-04-05","documents":[{"type":"Letter","date":"2024-04-08","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212839Orig1s009, s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-04-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212839s009s010lbl.pdf","untrusted":true}}],"fact_id":"f7e6c22b659cc9136615411f"},{"application":"NDA212839","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-01-26","documents":[{"type":"Label","date":"2024-01-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212839s008lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-01-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212839Orig1s008ltr.pdf","untrusted":true}}],"fact_id":"f8b66e720e90ec343bea59e3"},{"application":"NDA212839","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-06-27","documents":[{"type":"Letter","date":"2022-06-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212839Orig1s006, s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-06-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212839s006s007lbl.pdf","untrusted":true}}],"fact_id":"0f104449d5bc84084b11b5c3"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":6,"te_code_counts":{"NOT_PROVIDED":6},"marketing_status_counts":{"Prescription":6},"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":"NDA212839","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"XCOPRI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}},{"application":"NDA212839","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"XCOPRI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"12.5MG","untrusted":true}},{"application":"NDA212839","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"XCOPRI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"100MG","untrusted":true}},{"application":"NDA212839","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"XCOPRI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"25MG","untrusted":true}},{"application":"NDA212839","product_no":"005","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"XCOPRI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"150MG","untrusted":true}},{"application":"NDA212839","product_no":"006","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"XCOPRI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"200MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Cenobamate","untrusted":true},"brand":{"text":"Xcopri","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":3577855.23,"claims":3495,"beneficiaries":1114,"average_spending_per_claim_usd":1023.7067897,"fact_id":"3bae6630992a287aa0e181d1"},{"year":2021,"gross_spending_usd":32547978.33,"claims":28039,"beneficiaries":4124,"average_spending_per_claim_usd":1160.8109537,"fact_id":"2be886ae868ffe2e58aa3329"},{"year":2022,"gross_spending_usd":68154841.77,"claims":53354,"beneficiaries":6411,"average_spending_per_claim_usd":1277.4082875,"fact_id":"fcfa04f2fce44cf16442ec84"},{"year":2023,"gross_spending_usd":113076801.64,"claims":83222,"beneficiaries":9630,"average_spending_per_claim_usd":1358.7368922,"fact_id":"a8a06217df84d24528fe4ca9"},{"year":2024,"gross_spending_usd":164703012.87,"claims":117028,"beneficiaries":12500,"average_spending_per_claim_usd":1407.3812495,"fact_id":"6acdac2661195d8ab0ec1f99"}],"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; 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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":"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."}