{"answer":{"query":"Venclexta","resolved_as":"applications","packages":8,"applications":["NDA208573"],"identity":{"application_numbers":["NDA208573"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true},{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2016-04-11","latest":"2022-06-15","packages_with_a_start_date":8}},"generic_entry":[{"application":"NDA208573","date":"2033-09-06","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":"10993942","productNo":"002"},"latest_patent_expiry":"2033-09-06","latest_exclusivity_expiry":"2026-05-15","dated_barriers":33,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":10,"exclusivities_listed":1,"fact_id":"516ec6f9a90e7a8de1537415"}],"label_history":{"events_total":20,"non_cmc_events":20,"counts_by_class":{"EFFICACY":11,"LABELING":9},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA208573","submission_no":32,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-05-20","documents":[{"type":"Label","date":"2026-05-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208573s032lblCorrected.pdf","untrusted":true}},{"type":"Letter","date":"2026-05-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208573Orig1s032ltr.pdf","untrusted":true}}],"fact_id":"9b196d807ce81fa15a2351d4"},{"application":"NDA208573","submission_no":31,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-02-19","documents":[{"type":"Letter","date":"2026-02-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208573Orig1s031ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-02-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208573s031lbl.pdf","untrusted":true}}],"fact_id":"9a4f89278efe50fae205fd45"},{"application":"NDA208573","submission_no":27,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-06-15","documents":[{"type":"Letter","date":"2022-06-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208573Orig1s027ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-06-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208573s027lbl.pdf","untrusted":true}}],"fact_id":"7d5fcf8d2344c5bf75b80482"},{"application":"NDA208573","submission_no":26,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-10-22","documents":[{"type":"Letter","date":"2021-10-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208573Orig1s026ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-10-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208573s026lbl.pdf","untrusted":true}}],"fact_id":"11e2560645723573a5563a23"},{"application":"NDA208573","submission_no":24,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-10-04","documents":[{"type":"Label","date":"2021-10-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208573s024lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-10-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208573Orig1s024ltr.pdf","untrusted":true}}],"fact_id":"566cb2ab202d4fdbca63c3dc"}],"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":"NDA208573","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VENCLEXTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"100MG","untrusted":true}},{"application":"NDA208573","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VENCLEXTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}},{"application":"NDA208573","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VENCLEXTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"10MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Venetoclax","untrusted":true},"brand":{"text":"Venclexta","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":562138427.02,"claims":62465,"beneficiaries":13283,"average_spending_per_claim_usd":8999.2544148,"fact_id":"f39d2848a9803bbc921e7e65"},{"year":2021,"gross_spending_usd":690959199.31,"claims":76573,"beneficiaries":15965,"average_spending_per_claim_usd":9023.535702,"fact_id":"c040a102c1ef37df171fe605"},{"year":2022,"gross_spending_usd":757567013.05,"claims":83510,"beneficiaries":17540,"average_spending_per_claim_usd":9071.5724231,"fact_id":"04b6a2885373fc144711317d"},{"year":2023,"gross_spending_usd":814653974.96,"claims":89336,"beneficiaries":18792,"average_spending_per_claim_usd":9118.9887051,"fact_id":"4d506c1ae89887cff0f675c6"},{"year":2024,"gross_spending_usd":941720712.9,"claims":107871,"beneficiaries":21868,"average_spending_per_claim_usd":8730.0638068,"fact_id":"92e7fa469ba96f1ee2ba3890"}],"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."}