{"answer":{"query":"Jaypirca","resolved_as":"applications","packages":3,"applications":["NDA216059"],"identity":{"application_numbers":["NDA216059"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, COATED","untrusted":true}],"marketing_start":{"earliest":"2023-01-27","latest":"2023-02-15","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA216059","date":"2041-09-14","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":"12109193","productNo":"001"},"latest_patent_expiry":"2041-09-14","latest_exclusivity_expiry":"2032-12-03","dated_barriers":24,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":5,"fact_id":"0a5dca4f81cc65f7e113ec66"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"EFFICACY":3,"LABELING":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA216059","submission_no":6,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-10-02","documents":[{"type":"Label","date":"2026-10-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/216059s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-10-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/216059Orig1s006ltr.pdf","untrusted":true}}],"fact_id":"cbe0197c9b63743c0a5bc672"},{"application":"NDA216059","submission_no":5,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-12-02","documents":[{"type":"Label","date":"2025-12-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/216059s005lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-12-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/216059Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"916ee6a3ce31265aab1e67f9"},{"application":"NDA216059","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-06-04","documents":[{"type":"Letter","date":"2024-06-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/216059Orig1s002ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-06-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216059s002lbl.pdf","untrusted":true}}],"fact_id":"fb189531ce78613342a2ab09"},{"application":"NDA216059","submission_no":1,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-12-01","documents":[{"type":"Label","date":"2023-12-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216059s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-12-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216059Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"2697bf0c54f6e40df7181d9c"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":2},"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":"NDA216059","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"JAYPIRCA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"100MG","untrusted":true}},{"application":"NDA216059","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"JAYPIRCA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Pirtobrutinib","untrusted":true},"brand":{"text":"Jaypirca","untrusted":true}},"latest_year":2024,"series":[{"year":2023,"gross_spending_usd":49251882.85,"claims":2298,"beneficiaries":647,"average_spending_per_claim_usd":21432.499064,"fact_id":"149f8aff2ff84293088d2710"},{"year":2024,"gross_spending_usd":200562025.4,"claims":9927,"beneficiaries":1795,"average_spending_per_claim_usd":20203.689473,"fact_id":"bb5f3b8625c16f66733b3afa"}],"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":"pirtobrutinib","untrusted":true},"designation_count":5,"approved_count":4,"recent":[{"designated":"2026-08-22","use":{"text":"treatment of primary immune thrombocytopenia","untrusted":true},"status":"Designated","sponsor":{"text":"Eli Lilly and Company","untrusted":true},"approved":false},{"designated":"2020-09-14","use":{"text":"Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company","untrusted":true},"approved":true},{"designated":"2020-09-14","use":{"text":"Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company","untrusted":true},"approved":true},{"designated":"2020-09-14","use":{"text":"Treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company","untrusted":true},"approved":true},{"designated":"2020-08-28","use":{"text":"Treatment of mantle cell lymphoma","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Loxo Oncology, Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"31cca65915b3e7bbd65639d4"}],"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":1,"all_states_medicaid_reimbursed_usd":1312077.27,"all_states_medicaid_paid_prescriptions":65,"top_states":[{"state":"NY","medicaid_paid_prescriptions":65,"medicaid_reimbursed_usd":1312077.27,"total_reimbursed_usd":1312077.27,"packages":1,"covers":"all_record_types","fact_id":"0b09d4ad3c7a582bb10f9c07"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":317,"medicaid_reimbursed_usd":6352886,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":2,"facts_fee_for_service_only":0,"older_year_facts_not_used":0,"dataset":"State Drug Utilization Data 2024","read_on":"2026-11-07T23:59:45.983Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). 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":"04b7aa448ae176dfa3c09b91","field":"ndc.listing","entity":"ndc:00002690230"},{"fact_id":"03d5a419f107e4b2a1d5961d","field":"ndc.listing","entity":"ndc:00002702660"},{"fact_id":"312ddae8257c0662fc70a75d","field":"ndc.listing","entity":"ndc:00002702699"},{"fact_id":"0a5dca4f81cc65f7e113ec66","field":"drug.generic_entry_earliest","entity":"application:NDA216059"},{"fact_id":"171eb0227cb5b0331ee7e0da","field":"drug.patent","entity":"application:NDA216059"},{"fact_id":"a74d00b44864ad7b36f55db7","field":"drug.exclusivity","entity":"application:NDA216059"},{"fact_id":"cbe0197c9b63743c0a5bc672","field":"drug.label_event","entity":"application:NDA216059"},{"fact_id":"916ee6a3ce31265aab1e67f9","field":"drug.label_event","entity":"application:NDA216059"},{"fact_id":"fb189531ce78613342a2ab09","field":"drug.label_event","entity":"application:NDA216059"},{"fact_id":"2697bf0c54f6e40df7181d9c","field":"drug.label_event","entity":"application:NDA216059"},{"fact_id":"f958c966900215436e7a3614","field":"drug.marketing_status","entity":"application:NDA216059"},{"fact_id":"4618e1ba6b7d8161f2db5ef3","field":"drug.marketing_status","entity":"application:NDA216059"},{"fact_id":"149f8aff2ff84293088d2710","field":"drug.partd_spending","entity":"drug:pirtobrutinib|jaypirca"},{"fact_id":"bb5f3b8625c16f66733b3afa","field":"drug.partd_spending","entity":"drug:pirtobrutinib|jaypirca"},{"fact_id":"31cca65915b3e7bbd65639d4","field":"drug.orphan_designation","entity":"drug:pirtobrutinib"},{"fact_id":"0b09d4ad3c7a582bb10f9c07","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002702660: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."}