{"answer":{"query":"Ingrezza","resolved_as":"applications","packages":5,"applications":["NDA209241"],"identity":{"application_numbers":["NDA209241"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true},{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2017-10-04","latest":"2023-08-18","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA209241","date":"2040-08-10","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":"10940141","productNo":"002"},"latest_patent_expiry":"2040-08-10","latest_exclusivity_expiry":"2030-08-18","dated_barriers":72,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":22,"exclusivities_listed":2,"fact_id":"284ef295a8b2641cd115afbb"}],"label_history":{"events_total":10,"non_cmc_events":8,"counts_by_class":{"LABELING":6,"EFFICACY":2},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA209241","submission_no":34,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-10-23","documents":[{"type":"Letter","date":"2026-10-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/209241Orig1s034ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-10-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/209241Orig1s034lbl.pdf","untrusted":true}}],"fact_id":"5c3ff9e72b7c75a582cd3f94"},{"application":"NDA209241","submission_no":29,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-02-04","documents":[{"type":"Letter","date":"2025-02-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209241Orig1s029ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-02-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209241s029lbl.pdf","untrusted":true}}],"fact_id":"d32ca0d50d50999764e5b8d7"},{"application":"NDA209241","submission_no":28,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-11-22","documents":[{"type":"Letter","date":"2024-12-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209241Orig1s028ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-12-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209241orig1s028lbl.pdf","untrusted":true}}],"fact_id":"2cee5d32bf1d849884700b17"},{"application":"NDA209241","submission_no":26,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-08-18","documents":[{"type":"Label","date":"2023-08-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209241s026lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-08-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209241Orig1s026ltr.pdf","untrusted":true}}],"fact_id":"877e92584abb511dccf8d7a4"},{"application":"NDA209241","submission_no":20,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-04-23","documents":[{"type":"Letter","date":"2021-04-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209241Orig1s020ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-04-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209241Orig1s020lbl.pdf","untrusted":true}}],"fact_id":"4e3e9a8aebbf711045e8eabf"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"AB":3},"marketing_status_counts":{"Prescription":3},"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":"NDA209241","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INGREZZA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 40MG BASE","untrusted":true}},{"application":"NDA209241","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INGREZZA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 60MG BASE","untrusted":true}},{"application":"NDA209241","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INGREZZA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 80MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Valbenazine Tosylate","untrusted":true},"brand":{"text":"Ingrezza","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":788822963.21,"claims":111439,"beneficiaries":14767,"average_spending_per_claim_usd":7078.5179624,"fact_id":"4ee4dfee28807a587b00fbe3"},{"year":2021,"gross_spending_usd":918612514.45,"claims":129396,"beneficiaries":17393,"average_spending_per_claim_usd":7099.2342456,"fact_id":"5b5676fa4569f1284c87662d"},{"year":2022,"gross_spending_usd":1266279974.5,"claims":171758,"beneficiaries":23114,"average_spending_per_claim_usd":7372.4657629,"fact_id":"15a4d70c5e7145550f66d0a9"},{"year":2023,"gross_spending_usd":1705132722.7,"claims":224995,"beneficiaries":29191,"average_spending_per_claim_usd":7578.5360682,"fact_id":"121031dbea7a812aaa76c55f"},{"year":2024,"gross_spending_usd":1956616318.8,"claims":254899,"beneficiaries":32171,"average_spending_per_claim_usd":7676.045488,"fact_id":"f99677bd92038642d7add203"}],"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":"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."}