{"answer":{"query":"Nurtec ODT","resolved_as":"applications","packages":4,"applications":["NDA212728"],"identity":{"application_numbers":["NDA212728"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, ORALLY DISINTEGRATING","untrusted":true}],"marketing_start":{"earliest":"2020-03-05","latest":"2025-10-14","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA212728","date":"2039-03-25","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":"11083724","productNo":"001"},"latest_patent_expiry":"2039-03-25","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":3,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":0,"fact_id":"d373ec7b1d5c7da8c60a127a"}],"label_history":{"events_total":10,"non_cmc_events":9,"counts_by_class":{"LABELING":7,"EFFICACY":2},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA212728","submission_no":32,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-05-08","documents":[{"type":"Label","date":"2026-05-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/212728Orig1s032lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-05-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/212728Orig1s032ltr.pdf","untrusted":true}}],"fact_id":"ff011790c49cd8a8c4d6c12a"},{"application":"NDA212728","submission_no":29,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-03-16","documents":[{"type":"Letter","date":"2026-03-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/212728Orig1s029ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/212728s029lbl.pdf","untrusted":true}}],"fact_id":"3892dc92dc26e59c9d6861db"},{"application":"NDA212728","submission_no":28,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-08-01","documents":[{"type":"Label","date":"2025-08-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212728s028lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-08-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212728Orig1s028ltr.pdf","untrusted":true}}],"fact_id":"fc882d2dde6ca3d5f720a571"},{"application":"NDA212728","submission_no":26,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-21","documents":[{"type":"Label","date":"2025-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212728s026lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212728Orig1s026ltr.pdf","untrusted":true}}],"fact_id":"118e0b1cb60558473e7fbb35"},{"application":"NDA212728","submission_no":25,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-12-12","documents":[{"type":"Label","date":"2025-01-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212728Orig1s025Correctedlbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-01-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212728Orig1s025Correctedltr.pdf","untrusted":true}}],"fact_id":"bcb94c5fa926c3f994171083"}],"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":"NDA212728","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"NURTEC ODT","untrusted":true},"form":{"text":"TABLET, ORALLY DISINTEGRATING;ORAL","untrusted":true},"strength":{"text":"EQ 75MG BASE","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":4,"most_recent":[{"recall_number":"D-0451-2021","classification":"Class II","status":"Terminated","report_date":"2021-06-02","recall_initiated":"2021-03-15","recalling_firm":{"text":"Cardinal Health Inc.","untrusted":true},"reason":{"text":"CGMP Deviations: Intermittent exposure to temperature excursion during storage.","untrusted":true},"packages_named":3,"fact_id":"a83870f72c083ce6b417adcb"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Rimegepant Sulfate","untrusted":true},"brand":{"text":"Nurtec ODT","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":18933231.93,"claims":19444,"beneficiaries":8957,"average_spending_per_claim_usd":973.7313274,"fact_id":"3c389c1329d095aa770845c3"},{"year":2021,"gross_spending_usd":118402787.48,"claims":104314,"beneficiaries":32315,"average_spending_per_claim_usd":1135.0613291,"fact_id":"f7039ed51c47fb0c9d5a4919"},{"year":2022,"gross_spending_usd":276493155.34,"claims":207402,"beneficiaries":56513,"average_spending_per_claim_usd":1333.1267555,"fact_id":"2d6542314b0cf1ee2946de94"},{"year":2023,"gross_spending_usd":478240311.94,"claims":329578,"beneficiaries":83811,"average_spending_per_claim_usd":1451.0686755,"fact_id":"2a7b6ff827133f2df999c184"},{"year":2024,"gross_spending_usd":625230826.2,"claims":426648,"beneficiaries":105323,"average_spending_per_claim_usd":1465.4488623,"fact_id":"c4f03118b5b0b883cd20d073"}],"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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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. 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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":"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."}