{"answer":{"query":"Jakafi","resolved_as":"applications","packages":6,"applications":["NDA202192"],"identity":{"application_numbers":["NDA202192"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2011-11-16","latest":"2011-11-16","packages_with_a_start_date":6}},"generic_entry":[{"application":"NDA202192","date":"2029-03-22","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":"exclusivity","ref":"PED","productNo":"001"},"latest_patent_expiry":"2028-12-12","latest_exclusivity_expiry":"2029-03-22","dated_barriers":110,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":8,"exclusivities_listed":6,"fact_id":"908649e030e71bf85d1d2f0b"}],"label_history":{"events_total":21,"non_cmc_events":17,"counts_by_class":{"LABELING":9,"EFFICACY":8},"cmc_events":4,"recent_non_cmc_events":[{"application":"NDA202192","submission_no":33,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-07-20","documents":[{"type":"Letter","date":"2026-07-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202192Orig1s033; 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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":"NDA202192","product_no":"005","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"JAKAFI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 25MG BASE","untrusted":true}},{"application":"NDA202192","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"JAKAFI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 10MG BASE","untrusted":true}},{"application":"NDA202192","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"JAKAFI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 20MG BASE","untrusted":true}},{"application":"NDA202192","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"JAKAFI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 5MG BASE","untrusted":true}},{"application":"NDA202192","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"JAKAFI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 15MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Ruxolitinib Phosphate","untrusted":true},"brand":{"text":"Jakafi","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":1296674522.1,"claims":95023,"beneficiaries":11361,"average_spending_per_claim_usd":13645.901751,"fact_id":"4a933d150bbfbbe68115f553"},{"year":2021,"gross_spending_usd":1491163521.1,"claims":102750,"beneficiaries":12664,"average_spending_per_claim_usd":14512.540351,"fact_id":"8eb05e728d009f88033abbc9"},{"year":2022,"gross_spending_usd":1756404369.1,"claims":111112,"beneficiaries":13486,"average_spending_per_claim_usd":15807.512862,"fact_id":"5320d1135405bacbb702a32e"},{"year":2023,"gross_spending_usd":1940765068.5,"claims":116245,"beneficiaries":14041,"average_spending_per_claim_usd":16695.471362,"fact_id":"1982efd44b600687873189cb"},{"year":2024,"gross_spending_usd":2082741189.3,"claims":130891,"beneficiaries":15713,"average_spending_per_claim_usd":15912.027483,"fact_id":"945633122bb1db9420a712ca"}],"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."}