{"answer":{"query":"Welireg","resolved_as":"applications","packages":3,"applications":["NDA215383"],"identity":{"application_numbers":["NDA215383"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2021-08-13","latest":"2023-06-21","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA215383","date":"2042-06-30","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":"12358870","productNo":"001"},"latest_patent_expiry":"2042-06-30","latest_exclusivity_expiry":"2029-06-12","dated_barriers":9,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":5,"fact_id":"b175b78d88701f24bd88fc98"}],"label_history":{"events_total":8,"non_cmc_events":8,"counts_by_class":{"LABELING":2,"EFFICACY":6},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA215383","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-24","documents":[{"type":"Label","date":"2026-09-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215383s017lbl.pdf","untrusted":true}}],"fact_id":"64706d7516bd77884710bffe"},{"application":"NDA215383","submission_no":13,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-09-24","documents":[{"type":"Label","date":"2026-09-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215383s013lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-09-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215383Orig1s013ltr.pdf","untrusted":true}}],"fact_id":"49f60c47a586660ce22cb581"},{"application":"NDA215383","submission_no":15,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-06-12","documents":[{"type":"Letter","date":"2026-06-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/215383Orig1s015ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-16","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/215383s015lbl.pdf","untrusted":true}}],"fact_id":"f47958c7f67ea27c80f0312a"},{"application":"NDA215383","submission_no":12,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-05-14","documents":[{"type":"Label","date":"2025-05-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215383s012lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-05-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215383Orig1s012ltr.pdf","untrusted":true}}],"fact_id":"99827ae532c7b73b7f927e2b"},{"application":"NDA215383","submission_no":11,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-04-15","documents":[{"type":"Letter","date":"2025-04-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215383Orig1s010; s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-04-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215383s010s011lbl..pdf","untrusted":true}}],"fact_id":"b1586271c1370a21251d70de"}],"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":"NDA215383","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"WELIREG","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"40MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Belzutifan","untrusted":true},"brand":{"text":"Welireg","untrusted":true}},"latest_year":2024,"series":[{"year":2021,"gross_spending_usd":3981412.89,"claims":147,"beneficiaries":67,"average_spending_per_claim_usd":27084.441429,"fact_id":"b9d1b1c774e6985ff9322455"},{"year":2022,"gross_spending_usd":29705807.27,"claims":1170,"beneficiaries":222,"average_spending_per_claim_usd":25389.578863,"fact_id":"d9f796f9d8ee887474907570"},{"year":2023,"gross_spending_usd":59823809.58,"claims":2291,"beneficiaries":453,"average_spending_per_claim_usd":26112.531462,"fact_id":"dbfbfcb307466e34036e96f8"},{"year":2024,"gross_spending_usd":205460495.55,"claims":7964,"beneficiaries":1896,"average_spending_per_claim_usd":25798.655895,"fact_id":"7cd9b8c28fa3724477a9f9a5"}],"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":"belzutifan","untrusted":true},"designation_count":1,"approved_count":1,"recent":[{"designated":"2020-06-24","use":{"text":"Treatment of von Hippel-Lindau disease","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Merck Sharp & Dohme, LLC","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"f512c3163a7c3b60132ad1ce"}],"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":2025,"states_with_data":3,"all_states_medicaid_reimbursed_usd":6018973.63,"all_states_medicaid_paid_prescriptions":234,"top_states":[{"state":"IN","medicaid_paid_prescriptions":90,"medicaid_reimbursed_usd":2415644.17,"total_reimbursed_usd":2415644.17,"packages":1,"covers":"fee_for_service_only","fact_id":"93e01f51b930a8f979102d7e"},{"state":"PA","medicaid_paid_prescriptions":80,"medicaid_reimbursed_usd":2261644.76,"total_reimbursed_usd":2261644.76,"packages":1,"covers":"fee_for_service_only","fact_id":"75bf6c60d5278a09d14ee61b"},{"state":"IL","medicaid_paid_prescriptions":64,"medicaid_reimbursed_usd":1341684.7,"total_reimbursed_usd":1341684.7,"packages":1,"covers":"fee_for_service_only","fact_id":"b7a5c6c787b71ba0c84ada27"}],"unlabelled_state_code_xx":null,"built_from_facts":3,"facts_fee_for_service_only":3,"older_year_facts_not_used":5,"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":"737d3f0b522cc43914bd4c62","field":"ndc.listing","entity":"ndc:00006533101"},{"fact_id":"df08bb7240daea78a7d5317b","field":"ndc.listing","entity":"ndc:00006533158"},{"fact_id":"d3185300dfd772cdb949d83d","field":"ndc.listing","entity":"ndc:00006533159"},{"fact_id":"b175b78d88701f24bd88fc98","field":"drug.generic_entry_earliest","entity":"application:NDA215383"},{"fact_id":"9cc4e66a1421c1d164b3bb15","field":"drug.patent","entity":"application:NDA215383"},{"fact_id":"506dc049393a728a4c44aaaf","field":"drug.exclusivity","entity":"application:NDA215383"},{"fact_id":"64706d7516bd77884710bffe","field":"drug.label_event","entity":"application:NDA215383"},{"fact_id":"49f60c47a586660ce22cb581","field":"drug.label_event","entity":"application:NDA215383"},{"fact_id":"f47958c7f67ea27c80f0312a","field":"drug.label_event","entity":"application:NDA215383"},{"fact_id":"99827ae532c7b73b7f927e2b","field":"drug.label_event","entity":"application:NDA215383"},{"fact_id":"b1586271c1370a21251d70de","field":"drug.label_event","entity":"application:NDA215383"},{"fact_id":"5c52273e5238de464fae5472","field":"drug.marketing_status","entity":"application:NDA215383"},{"fact_id":"b9d1b1c774e6985ff9322455","field":"drug.partd_spending","entity":"drug:belzutifan|welireg"},{"fact_id":"d9f796f9d8ee887474907570","field":"drug.partd_spending","entity":"drug:belzutifan|welireg"},{"fact_id":"dbfbfcb307466e34036e96f8","field":"drug.partd_spending","entity":"drug:belzutifan|welireg"},{"fact_id":"7cd9b8c28fa3724477a9f9a5","field":"drug.partd_spending","entity":"drug:belzutifan|welireg"},{"fact_id":"f512c3163a7c3b60132ad1ce","field":"drug.orphan_designation","entity":"drug:belzutifan"},{"fact_id":"93e01f51b930a8f979102d7e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006533101:IN"},{"fact_id":"75bf6c60d5278a09d14ee61b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006533101:PA"},{"fact_id":"b7a5c6c787b71ba0c84ada27","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00006533101:IL"}],"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."}