{"answer":{"query":"Rinvoq","resolved_as":"applications","packages":8,"applications":["NDA211675","NDA218347"],"identity":{"application_numbers":["NDA211675","NDA218347"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, EXTENDED RELEASE","untrusted":true},{"text":"SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2019-08-16","latest":"2024-04-26","packages_with_a_start_date":8}},"generic_entry":[{"application":"NDA211675","date":"2038-03-09","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":"11564922","productNo":"001"},"latest_patent_expiry":"2038-03-09","latest_exclusivity_expiry":"2032-04-28","dated_barriers":89,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":45,"exclusivities_listed":6,"fact_id":"fae8cdd58b65af74d69a35a3"},{"application":"NDA218347","date":"2036-10-17","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; 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Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Upadacitinib","untrusted":true},"brand":{"text":"Rinvoq","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":191260329.12,"claims":35222,"beneficiaries":7100,"average_spending_per_claim_usd":5430.1382409,"fact_id":"82b91113226fcd8fd7b85d68"},{"year":2021,"gross_spending_usd":411512943.73,"claims":70368,"beneficiaries":11596,"average_spending_per_claim_usd":5848.0125018,"fact_id":"847e3e3508d32bb8a278e20c"},{"year":2022,"gross_spending_usd":622108916.99,"claims":99523,"beneficiaries":15674,"average_spending_per_claim_usd":6250.9059915,"fact_id":"91511f575ffb1893ce0dda7b"},{"year":2023,"gross_spending_usd":976330770.88,"claims":142486,"beneficiaries":21424,"average_spending_per_claim_usd":6852.1171966,"fact_id":"16c15a88a815841c22cece94"},{"year":2024,"gross_spending_usd":1385459851.4,"claims":193864,"beneficiaries":29062,"average_spending_per_claim_usd":7146.5555825,"fact_id":"d4b30c9682177c077ece5750"}],"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":"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."}