{"answer":{"query":"Vonjo","resolved_as":"applications","packages":1,"applications":["NDA208712"],"identity":{"application_numbers":["NDA208712"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2022-02-28","latest":"2022-02-28","packages_with_a_start_date":1}},"generic_entry":[{"application":"NDA208712","date":"2030-03-25","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":"8980873","productNo":"001"},"latest_patent_expiry":"2030-03-25","latest_exclusivity_expiry":"2029-02-28","dated_barriers":5,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":2,"fact_id":"c5d696c3ee6b2bdacbe54834"}],"label_history":{"events_total":6,"non_cmc_events":6,"counts_by_class":{"LABELING":6},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA208712","submission_no":9,"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/2026/208712Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-07-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208712s009lbl.pdf","untrusted":true}}],"fact_id":"c469509a3731b3489a3b842a"},{"application":"NDA208712","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-03-18","documents":[{"type":"Letter","date":"2026-03-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208712Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208712s007lbl.pdf","untrusted":true}}],"fact_id":"6313a56f05469c81330d20ba"},{"application":"NDA208712","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-10-01","documents":[{"type":"Letter","date":"2025-10-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208712Orig1s004ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-10-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208712s004lbl.pdf","untrusted":true}}],"fact_id":"832cbcc083c3550b84ff74f6"},{"application":"NDA208712","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-08-22","documents":[{"type":"Label","date":"2025-08-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208712s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-08-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208712Orig1s006ltr.pdf","untrusted":true}}],"fact_id":"85c98c8b9ce462c1d2e023ff"},{"application":"NDA208712","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-11-12","documents":[{"type":"Letter","date":"2024-11-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208712Orig1s003ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-11-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208712s003lbl.pdf","untrusted":true}}],"fact_id":"b82ea31aecdd647682317ebb"}],"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":"NDA208712","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"VONJO","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 100MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Pacritinib Citrate","untrusted":true},"brand":{"text":"Vonjo","untrusted":true}},"latest_year":2024,"series":[{"year":2022,"gross_spending_usd":37696367.44,"claims":1918,"beneficiaries":584,"average_spending_per_claim_usd":19653.997623,"fact_id":"dcc92bea59378d773fca3827"},{"year":2023,"gross_spending_usd":92544883.16,"claims":4256,"beneficiaries":950,"average_spending_per_claim_usd":21744.568412,"fact_id":"bb36e453e87410cb5af084e2"},{"year":2024,"gross_spending_usd":110818538.14,"claims":5065,"beneficiaries":1046,"average_spending_per_claim_usd":21879.277027,"fact_id":"b02558d5648b046439abd59c"}],"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; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"orphan_designation":{"ingredients":[{"ingredient":{"text":"pacritinib","untrusted":true},"designation_count":1,"approved_count":1,"recent":[{"designated":"2008-03-13","use":{"text":"Treatment of primary myelofibrosis (MF), post-polycythemia vera MF, and post-essential thrombocythemia MF","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Sobi, Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"05ff4e286b79b5b850e7f1bd"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2024,"states_with_data":0,"all_states_medicaid_reimbursed_usd":0,"all_states_medicaid_paid_prescriptions":0,"top_states":[],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":256,"medicaid_reimbursed_usd":5398593.57,"note":"the source uses the code XX without defining it; 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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. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"78c3cba780c78b418e96030b","field":"ndc.listing","entity":"ndc:72482010012"},{"fact_id":"c5d696c3ee6b2bdacbe54834","field":"drug.generic_entry_earliest","entity":"application:NDA208712"},{"fact_id":"4d96ebca034dcb9950c89e8a","field":"drug.patent","entity":"application:NDA208712"},{"fact_id":"7c2958b7b841b4be8f41b942","field":"drug.exclusivity","entity":"application:NDA208712"},{"fact_id":"c469509a3731b3489a3b842a","field":"drug.label_event","entity":"application:NDA208712"},{"fact_id":"6313a56f05469c81330d20ba","field":"drug.label_event","entity":"application:NDA208712"},{"fact_id":"832cbcc083c3550b84ff74f6","field":"drug.label_event","entity":"application:NDA208712"},{"fact_id":"85c98c8b9ce462c1d2e023ff","field":"drug.label_event","entity":"application:NDA208712"},{"fact_id":"b82ea31aecdd647682317ebb","field":"drug.label_event","entity":"application:NDA208712"},{"fact_id":"934e1adcfa7508e53406cbc0","field":"drug.marketing_status","entity":"application:NDA208712"},{"fact_id":"dcc92bea59378d773fca3827","field":"drug.partd_spending","entity":"drug:pacritinib-citrate|vonjo"},{"fact_id":"bb36e453e87410cb5af084e2","field":"drug.partd_spending","entity":"drug:pacritinib-citrate|vonjo"},{"fact_id":"b02558d5648b046439abd59c","field":"drug.partd_spending","entity":"drug:pacritinib-citrate|vonjo"},{"fact_id":"05ff4e286b79b5b850e7f1bd","field":"drug.orphan_designation","entity":"drug:pacritinib"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. 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."}