{"answer":{"query":"Ojjaara","resolved_as":"applications","packages":3,"applications":["NDA216873"],"identity":{"application_numbers":["NDA216873"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2023-09-15","latest":"2023-09-15","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA216873","date":"2040-12-02","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":"11963962","productNo":"001"},"latest_patent_expiry":"2040-12-02","latest_exclusivity_expiry":"2030-09-15","dated_barriers":21,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":5,"exclusivities_listed":2,"fact_id":"9404583abb935d01e6373af1"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"LABELING":4},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA216873","submission_no":6,"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/2026/216873Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-07-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216873s006lbl.pdf","untrusted":true}}],"fact_id":"3c2f65ef6183ef3408b6dc91"},{"application":"NDA216873","submission_no":5,"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/2026/216873Orig1s004,s005ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216873s005lbl.pdf","untrusted":true}}],"fact_id":"7cddb8fe1177912c499377df"},{"application":"NDA216873","submission_no":4,"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/2026/216873Orig1s004,s005ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216873s004lbl.pdf","untrusted":true}}],"fact_id":"b28d33bb65a1c209aaf32a1f"},{"application":"NDA216873","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-04-18","documents":[{"type":"Label","date":"2025-04-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216873s002lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-04-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216873Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"29136398d210a38668befcd2"}],"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":{"NOT_PROVIDED":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":"NDA216873","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"OJJAARA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 150MG BASE","untrusted":true}},{"application":"NDA216873","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"OJJAARA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 100MG BASE","untrusted":true}},{"application":"NDA216873","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"OJJAARA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 200MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Momelotinib Dihydrochloride","untrusted":true},"brand":{"text":"Ojjaara","untrusted":true}},"latest_year":2024,"series":[{"year":2023,"gross_spending_usd":27017097.61,"claims":934,"beneficiaries":486,"average_spending_per_claim_usd":28926.228704,"fact_id":"b8c14e491386b24bd159d085"},{"year":2024,"gross_spending_usd":341692381.97,"claims":12239,"beneficiaries":2316,"average_spending_per_claim_usd":27918.325188,"fact_id":"9eee0bf57caf1284d67b9ed4"}],"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":"momelotinib","untrusted":true},"designation_count":2,"approved_count":1,"recent":[{"designated":"2026-04-18","use":{"text":"treatment of Vacuoles E1 enzyme, X-linked autoinflammatory, somatic (VEXAS) syndrome","untrusted":true},"status":"Designated","sponsor":{"text":"GlaxoSmithKline","untrusted":true},"approved":false},{"designated":"2010-08-05","use":{"text":"Treatment of myelofibrosis","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"GlaxoSmithKline","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"179b4eedfef5e10a118bd225"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; 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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":"ce048eaa5a956b16bc0e06d8","field":"ndc.listing","entity":"ndc:81864010130"},{"fact_id":"a454130d0757cdd5fa6b1350","field":"ndc.listing","entity":"ndc:81864010230"},{"fact_id":"082868d4f9928cdeb08a2d68","field":"ndc.listing","entity":"ndc:81864010330"},{"fact_id":"9404583abb935d01e6373af1","field":"drug.generic_entry_earliest","entity":"application:NDA216873"},{"fact_id":"a7bf2f29c0f08607423d76ea","field":"drug.patent","entity":"application:NDA216873"},{"fact_id":"8affd8c5ee07d7749dd70e0a","field":"drug.exclusivity","entity":"application:NDA216873"},{"fact_id":"3c2f65ef6183ef3408b6dc91","field":"drug.label_event","entity":"application:NDA216873"},{"fact_id":"7cddb8fe1177912c499377df","field":"drug.label_event","entity":"application:NDA216873"},{"fact_id":"b28d33bb65a1c209aaf32a1f","field":"drug.label_event","entity":"application:NDA216873"},{"fact_id":"29136398d210a38668befcd2","field":"drug.label_event","entity":"application:NDA216873"},{"fact_id":"ebaddb168da2b077e3bf2087","field":"drug.marketing_status","entity":"application:NDA216873"},{"fact_id":"cca98640a92cffcce66f9891","field":"drug.marketing_status","entity":"application:NDA216873"},{"fact_id":"c8785bc6ef0dfeef38ed4064","field":"drug.marketing_status","entity":"application:NDA216873"},{"fact_id":"b8c14e491386b24bd159d085","field":"drug.partd_spending","entity":"drug:momelotinib-dihydrochloride|ojjaara"},{"fact_id":"9eee0bf57caf1284d67b9ed4","field":"drug.partd_spending","entity":"drug:momelotinib-dihydrochloride|ojjaara"},{"fact_id":"179b4eedfef5e10a118bd225","field":"drug.orphan_designation","entity":"drug:momelotinib"},{"fact_id":"bdb1bc4de67dd3b59850640a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:81864010130:NY"}],"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."}