{"answer":{"query":"Cresemba","resolved_as":"applications","packages":3,"applications":["NDA207500","NDA207501"],"identity":{"application_numbers":["NDA207500","NDA207501"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION","untrusted":true},{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2015-03-06","latest":"2022-11-22","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA207500","date":"2031-06-08","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":"2028-03-14","latest_exclusivity_expiry":"2031-06-08","dated_barriers":29,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":10,"fact_id":"e2dbd16f72536ea69cc1dd97"},{"application":"NDA207501","date":"2031-06-08","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":"2026-04-30","latest_exclusivity_expiry":"2031-06-08","dated_barriers":11,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":9,"fact_id":"361191e03479749d5f69886e"}],"label_history":{"events_total":18,"non_cmc_events":16,"counts_by_class":{"LABELING":14,"EFFICACY":2},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA207500","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-24","documents":[{"type":"Label","date":"2025-03-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207500s016,207501s016lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207500Orig1s016, 207501Orig1s016ltr.pdf","untrusted":true}}],"fact_id":"cbd26bf211df76b2e5be323a"},{"application":"NDA207501","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-24","documents":[{"type":"Label","date":"2025-03-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/207500s016,207501s016lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/207500Orig1s016, 207501Orig1s016ltr.pdf","untrusted":true}}],"fact_id":"6acb843eef9d3c36b10c58e8"},{"application":"NDA207500","submission_no":15,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-12-08","documents":[{"type":"Label","date":"2023-12-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207500s015,207501s013lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-12-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207500Orig1s015; 207501Orig1s013ltr.pdf","untrusted":true}}],"fact_id":"569d903fe9c3e73602a3155b"},{"application":"NDA207501","submission_no":13,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-12-08","documents":[{"type":"Letter","date":"2023-12-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/207500Orig1s015; 207501Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-12-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207500s015,207501s013lbl.pdf","untrusted":true}}],"fact_id":"7d0f5d5a0464eed964b87a71"},{"application":"NDA207500","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-02-17","documents":[{"type":"Label","date":"2022-02-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/207500s011,207501s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2022-05-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/207500Orig1s011; 207501Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"82ff51f84299acc430d65f41"}],"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":"NDA207500","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"CRESEMBA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"186MG","untrusted":true}},{"application":"NDA207500","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"CRESEMBA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"74.5MG","untrusted":true}},{"application":"NDA207501","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"CRESEMBA","untrusted":true},"form":{"text":"POWDER;INTRAVENOUS","untrusted":true},"strength":{"text":"372MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Isavuconazonium Sulfate","untrusted":true},"brand":{"text":"Cresemba*","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":55590672.3,"claims":10209,"beneficiaries":2342,"average_spending_per_claim_usd":5445.2612695,"fact_id":"dea0c63411c1165b836467ea"},{"year":2021,"gross_spending_usd":59881232.63,"claims":10606,"beneficiaries":2552,"average_spending_per_claim_usd":5645.9770536,"fact_id":"f15751d75ad3460500f8079d"},{"year":2022,"gross_spending_usd":72575256.28,"claims":12149,"beneficiaries":2934,"average_spending_per_claim_usd":5973.7637896,"fact_id":"65a3c735f50dbd4879cef287"},{"year":2023,"gross_spending_usd":95684253.21,"claims":14677,"beneficiaries":3570,"average_spending_per_claim_usd":6519.3331887,"fact_id":"cac0ea49f2795ae2ede86160"},{"year":2024,"gross_spending_usd":123034268.62,"claims":19216,"beneficiaries":4665,"average_spending_per_claim_usd":6402.6992413,"fact_id":"22be46a383771fc12da0efb9"}],"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}}},"medicaid_state_utilization":{"year":2025,"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":200,"medicaid_reimbursed_usd":664424.95,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":24,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","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":"646f116fb19e153a599f3e81","field":"ndc.listing","entity":"ndc:00469042001"},{"fact_id":"f1dc7ac964c9755bf0353056","field":"ndc.listing","entity":"ndc:00469052002"},{"fact_id":"755a0d2da5fbb622d98fe63a","field":"ndc.listing","entity":"ndc:00469286035"},{"fact_id":"e2dbd16f72536ea69cc1dd97","field":"drug.generic_entry_earliest","entity":"application:NDA207500"},{"fact_id":"d4c3c0c8c12239420767167e","field":"drug.patent","entity":"application:NDA207500"},{"fact_id":"58925242e9c9640a344b0603","field":"drug.exclusivity","entity":"application:NDA207500"},{"fact_id":"361191e03479749d5f69886e","field":"drug.generic_entry_earliest","entity":"application:NDA207501"},{"fact_id":"243d837b2cc6e797d3444b36","field":"drug.patent","entity":"application:NDA207501"},{"fact_id":"ba8bdc19d5591c4c3feee15e","field":"drug.exclusivity","entity":"application:NDA207501"},{"fact_id":"cbd26bf211df76b2e5be323a","field":"drug.label_event","entity":"application:NDA207500"},{"fact_id":"6acb843eef9d3c36b10c58e8","field":"drug.label_event","entity":"application:NDA207501"},{"fact_id":"569d903fe9c3e73602a3155b","field":"drug.label_event","entity":"application:NDA207500"},{"fact_id":"7d0f5d5a0464eed964b87a71","field":"drug.label_event","entity":"application:NDA207501"},{"fact_id":"82ff51f84299acc430d65f41","field":"drug.label_event","entity":"application:NDA207500"},{"fact_id":"86df55ed213e78ae4ae642d5","field":"drug.marketing_status","entity":"application:NDA207500"},{"fact_id":"1f23eb6fc58f5d0c36d3cbaf","field":"drug.marketing_status","entity":"application:NDA207500"},{"fact_id":"1e41b831a20a8ae7cb1da8cf","field":"drug.marketing_status","entity":"application:NDA207501"},{"fact_id":"dea0c63411c1165b836467ea","field":"drug.partd_spending","entity":"drug:isavuconazonium-sulfate|cresemba"},{"fact_id":"f15751d75ad3460500f8079d","field":"drug.partd_spending","entity":"drug:isavuconazonium-sulfate|cresemba"},{"fact_id":"65a3c735f50dbd4879cef287","field":"drug.partd_spending","entity":"drug:isavuconazonium-sulfate|cresemba"},{"fact_id":"cac0ea49f2795ae2ede86160","field":"drug.partd_spending","entity":"drug:isavuconazonium-sulfate|cresemba"},{"fact_id":"22be46a383771fc12da0efb9","field":"drug.partd_spending","entity":"drug:isavuconazonium-sulfate|cresemba"}],"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":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is 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."}