{"answer":{"query":"Kerendia","resolved_as":"applications","packages":12,"applications":["NDA215341"],"identity":{"application_numbers":["NDA215341"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true},{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2021-07-09","latest":"2025-08-23","packages_with_a_start_date":12}},"generic_entry":[{"application":"NDA215341","date":"2035-07-29","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":"RE49826","productNo":"002"},"latest_patent_expiry":"2035-07-29","latest_exclusivity_expiry":"2029-09-16","dated_barriers":15,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":4,"fact_id":"4ad5f8f3baa3f2ae0c45312a"}],"label_history":{"events_total":3,"non_cmc_events":3,"counts_by_class":{"EFFICACY":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA215341","submission_no":11,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-09-16","documents":[{"type":"Letter","date":"2026-09-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215341Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215341s011lbl.pdf","untrusted":true}}],"fact_id":"02e0b48dd5675c8db22d160f"},{"application":"NDA215341","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-07-11","documents":[{"type":"Label","date":"2026-05-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215341Orig1s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-07-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215341Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"a2f92ab56cbd609dd5349288"},{"application":"NDA215341","submission_no":1,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-09-01","documents":[{"type":"Letter","date":"2022-09-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215341Orig1s001ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-09-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215341s001lbl.pdf","untrusted":true}}],"fact_id":"f730ca58d62b4387ccf6e98d"}],"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":"NDA215341","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"KERENDIA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"20MG","untrusted":true}},{"application":"NDA215341","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"KERENDIA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"10MG","untrusted":true}},{"application":"NDA215341","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"KERENDIA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"40MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Finerenone","untrusted":true},"brand":{"text":"Kerendia","untrusted":true}},"latest_year":2024,"series":[{"year":2021,"gross_spending_usd":2849277.98,"claims":3512,"beneficiaries":1908,"average_spending_per_claim_usd":811.2978303,"fact_id":"affddafdfb7c3e1bf564f581"},{"year":2022,"gross_spending_usd":74078624.21,"claims":84126,"beneficiaries":25931,"average_spending_per_claim_usd":880.56753215,"fact_id":"8b84f5b531faa1050c7d3f67"},{"year":2023,"gross_spending_usd":269681549.35,"claims":271195,"beneficiaries":63625,"average_spending_per_claim_usd":994.41932687,"fact_id":"9d9c0153ac220223e18e5c37"},{"year":2024,"gross_spending_usd":396302773.23,"claims":403577,"beneficiaries":88208,"average_spending_per_claim_usd":981.97561613,"fact_id":"87b076dd55bbc3b964304085"}],"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":15,"all_states_medicaid_reimbursed_usd":988046.58,"all_states_medicaid_paid_prescriptions":1253,"top_states":[{"state":"NC","medicaid_paid_prescriptions":73,"medicaid_reimbursed_usd":94929.7,"total_reimbursed_usd":94929.7,"packages":1,"covers":"fee_for_service_only","fact_id":"4c7fcbfad1642ab484c291f3"},{"state":"NJ","medicaid_paid_prescriptions":95,"medicaid_reimbursed_usd":83497.34,"total_reimbursed_usd":83497.34,"packages":1,"covers":"all_record_types","fact_id":"3268a55404a82be2bd5cff32"},{"state":"IA","medicaid_paid_prescriptions":125,"medicaid_reimbursed_usd":81816.83,"total_reimbursed_usd":81816.83,"packages":1,"covers":"all_record_types","fact_id":"5fff38990281e12c299ffc40"},{"state":"SC","medicaid_paid_prescriptions":114,"medicaid_reimbursed_usd":73822.77,"total_reimbursed_usd":73822.77,"packages":1,"covers":"fee_for_service_only","fact_id":"c8cc2ac22d4207593522060c"},{"state":"IN","medicaid_paid_prescriptions":56,"medicaid_reimbursed_usd":72981.55,"total_reimbursed_usd":72981.55,"packages":1,"covers":"fee_for_service_only","fact_id":"ca9e813651732d880a42778e"},{"state":"OR","medicaid_paid_prescriptions":102,"medicaid_reimbursed_usd":71673.74,"total_reimbursed_usd":71732.54,"packages":1,"covers":"all_record_types","fact_id":"27909166c605eb7a2161c34d"},{"state":"MN","medicaid_paid_prescriptions":97,"medicaid_reimbursed_usd":66702.69,"total_reimbursed_usd":66702.69,"packages":1,"covers":"fee_for_service_only","fact_id":"0f1705d6509e47d5f00bdd81"},{"state":"VA","medicaid_paid_prescriptions":88,"medicaid_reimbursed_usd":63877.77,"total_reimbursed_usd":63877.77,"packages":1,"covers":"all_record_types","fact_id":"2fbc2b9b984de8e03322be54"},{"state":"ID","medicaid_paid_prescriptions":95,"medicaid_reimbursed_usd":63877.28,"total_reimbursed_usd":63877.28,"packages":1,"covers":"all_record_types","fact_id":"8a2399b4d3a24d811588e9e7"},{"state":"TX","medicaid_paid_prescriptions":57,"medicaid_reimbursed_usd":61829.73,"total_reimbursed_usd":61829.73,"packages":1,"covers":"fee_for_service_only","fact_id":"6aa86cdbd66b8abe1bc5cf08"}],"unlabelled_state_code_xx":null,"built_from_facts":15,"facts_fee_for_service_only":6,"older_year_facts_not_used":83,"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":"7cc488de9ac2e98b3f893faf","field":"ndc.listing","entity":"ndc:50419054001"},{"fact_id":"dc20b17c3371005f6b6a69b3","field":"ndc.listing","entity":"ndc:50419054002"},{"fact_id":"ddc9fd6a47e09b82c7d32101","field":"ndc.listing","entity":"ndc:50419054006"},{"fact_id":"4ad5f8f3baa3f2ae0c45312a","field":"drug.generic_entry_earliest","entity":"application:NDA215341"},{"fact_id":"9712970b71dc7787da5d1091","field":"drug.patent","entity":"application:NDA215341"},{"fact_id":"94a1da7905fddce7d5ad6b1f","field":"drug.exclusivity","entity":"application:NDA215341"},{"fact_id":"02e0b48dd5675c8db22d160f","field":"drug.label_event","entity":"application:NDA215341"},{"fact_id":"a2f92ab56cbd609dd5349288","field":"drug.label_event","entity":"application:NDA215341"},{"fact_id":"f730ca58d62b4387ccf6e98d","field":"drug.label_event","entity":"application:NDA215341"},{"fact_id":"cbecbccf2498103c5e8d4da7","field":"drug.marketing_status","entity":"application:NDA215341"},{"fact_id":"7b92032631c32337d352070e","field":"drug.marketing_status","entity":"application:NDA215341"},{"fact_id":"739066ba0b035a33d42a2ac5","field":"drug.marketing_status","entity":"application:NDA215341"},{"fact_id":"affddafdfb7c3e1bf564f581","field":"drug.partd_spending","entity":"drug:finerenone|kerendia"},{"fact_id":"8b84f5b531faa1050c7d3f67","field":"drug.partd_spending","entity":"drug:finerenone|kerendia"},{"fact_id":"9d9c0153ac220223e18e5c37","field":"drug.partd_spending","entity":"drug:finerenone|kerendia"},{"fact_id":"87b076dd55bbc3b964304085","field":"drug.partd_spending","entity":"drug:finerenone|kerendia"},{"fact_id":"4c7fcbfad1642ab484c291f3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419054102:NC"},{"fact_id":"3268a55404a82be2bd5cff32","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419054102:NJ"},{"fact_id":"5fff38990281e12c299ffc40","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419054101:IA"},{"fact_id":"c8cc2ac22d4207593522060c","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419054101:SC"},{"fact_id":"ca9e813651732d880a42778e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419054002:IN"},{"fact_id":"27909166c605eb7a2161c34d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419054001:OR"},{"fact_id":"0f1705d6509e47d5f00bdd81","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419054101:MN"},{"fact_id":"2fbc2b9b984de8e03322be54","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419054002:VA"},{"fact_id":"8a2399b4d3a24d811588e9e7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419054101:ID"},{"fact_id":"6aa86cdbd66b8abe1bc5cf08","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419054102:TX"}],"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."}