{"answer":{"query":"Erivedge","resolved_as":"applications","packages":2,"applications":["NDA203388"],"identity":{"application_numbers":["NDA203388"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2012-01-30","latest":"2013-04-09","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA203388","date":"2028-12-15","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":"9278961","productNo":"001"},"latest_patent_expiry":"2028-12-15","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":2,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":0,"fact_id":"88354fc69855c20f5ce64712"}],"label_history":{"events_total":14,"non_cmc_events":10,"counts_by_class":{"LABELING":9,"EFFICACY":1},"cmc_events":4,"recent_non_cmc_events":[{"application":"NDA203388","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-03-27","documents":[{"type":"Letter","date":"2023-03-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/203388Orig1s017ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-03-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/203388s017lbl.pdf","untrusted":true}}],"fact_id":"3a5466bb27d8317ca0c1893b"},{"application":"NDA203388","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-07-31","documents":[{"type":"Letter","date":"2020-08-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203388Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-08-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203388s016lbl.pdf","untrusted":true}}],"fact_id":"1219e3d4fe46238c42c595df"},{"application":"NDA203388","submission_no":14,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-03-26","documents":[{"type":"Label","date":"2019-03-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203388s014lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-03-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203388Orig1s014ltr.pdf","untrusted":true}}],"fact_id":"92a987479cbade49ce15ae53"},{"application":"NDA203388","submission_no":12,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-01-18","documents":[{"type":"Label","date":"2019-01-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/203388s012lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-01-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/203388Orig1s012ltr.pdf","untrusted":true}}],"fact_id":"9cdb19f18cc9af700c862163"},{"application":"NDA203388","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-08-01","documents":[{"type":"Label","date":"2017-08-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203388s011lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-08-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/203388Orig1s011ltr.pdf","untrusted":true}}],"fact_id":"2c809d4cbf0b964e491de800"}],"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":"NDA203388","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ERIVEDGE","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"150MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Vismodegib","untrusted":true},"brand":{"text":"Erivedge","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":138064673,"claims":11705,"beneficiaries":2352,"average_spending_per_claim_usd":11795.35865,"fact_id":"3df86b26c78e9cda777b53de"},{"year":2021,"gross_spending_usd":140212164.51,"claims":11633,"beneficiaries":2538,"average_spending_per_claim_usd":12052.966948,"fact_id":"47ca3d5fe5a6a292ace4f2b5"},{"year":2022,"gross_spending_usd":124771563,"claims":9973,"beneficiaries":2275,"average_spending_per_claim_usd":12510.935827,"fact_id":"b0cd5e211d9a6b00af7fa0ab"},{"year":2023,"gross_spending_usd":102945428.3,"claims":7735,"beneficiaries":1719,"average_spending_per_claim_usd":13309.040504,"fact_id":"03aa08685fef2d95e9fb67b7"},{"year":2024,"gross_spending_usd":116769823.67,"claims":9065,"beneficiaries":1870,"average_spending_per_claim_usd":12881.392573,"fact_id":"4117d7f4e6dbcb415f1f5184"}],"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":4,"all_states_medicaid_reimbursed_usd":3463683.22,"all_states_medicaid_paid_prescriptions":307,"top_states":[{"state":"FL","medicaid_paid_prescriptions":107,"medicaid_reimbursed_usd":1356220.88,"total_reimbursed_usd":1356220.88,"packages":1,"covers":"fee_for_service_only","fact_id":"2d95ce1d9439a3e70ec839b7"},{"state":"NC","medicaid_paid_prescriptions":68,"medicaid_reimbursed_usd":794113.01,"total_reimbursed_usd":914092.7,"packages":1,"covers":"fee_for_service_only","fact_id":"b76df0cd6acb3a7ae5bac609"},{"state":"VA","medicaid_paid_prescriptions":59,"medicaid_reimbursed_usd":686805.55,"total_reimbursed_usd":686805.55,"packages":1,"covers":"all_record_types","fact_id":"452dee39e2aeccf54e614a81"},{"state":"KY","medicaid_paid_prescriptions":73,"medicaid_reimbursed_usd":626543.78,"total_reimbursed_usd":626543.78,"packages":1,"covers":"all_record_types","fact_id":"48063677f4cdb7782054eacd"}],"unlabelled_state_code_xx":null,"built_from_facts":4,"facts_fee_for_service_only":2,"older_year_facts_not_used":7,"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":"9a773cbbc03aa335024bc8f2","field":"ndc.listing","entity":"ndc:50242014001"},{"fact_id":"cdbe65da55dfba815e3d6241","field":"ndc.listing","entity":"ndc:50242014086"},{"fact_id":"88354fc69855c20f5ce64712","field":"drug.generic_entry_earliest","entity":"application:NDA203388"},{"fact_id":"df5876f9d236be030c10d2ba","field":"drug.patent","entity":"application:NDA203388"},{"fact_id":"3a5466bb27d8317ca0c1893b","field":"drug.label_event","entity":"application:NDA203388"},{"fact_id":"1219e3d4fe46238c42c595df","field":"drug.label_event","entity":"application:NDA203388"},{"fact_id":"92a987479cbade49ce15ae53","field":"drug.label_event","entity":"application:NDA203388"},{"fact_id":"9cdb19f18cc9af700c862163","field":"drug.label_event","entity":"application:NDA203388"},{"fact_id":"2c809d4cbf0b964e491de800","field":"drug.label_event","entity":"application:NDA203388"},{"fact_id":"8ac016aca26e248f0bbc5380","field":"drug.marketing_status","entity":"application:NDA203388"},{"fact_id":"3df86b26c78e9cda777b53de","field":"drug.partd_spending","entity":"drug:vismodegib|erivedge"},{"fact_id":"47ca3d5fe5a6a292ace4f2b5","field":"drug.partd_spending","entity":"drug:vismodegib|erivedge"},{"fact_id":"b0cd5e211d9a6b00af7fa0ab","field":"drug.partd_spending","entity":"drug:vismodegib|erivedge"},{"fact_id":"03aa08685fef2d95e9fb67b7","field":"drug.partd_spending","entity":"drug:vismodegib|erivedge"},{"fact_id":"4117d7f4e6dbcb415f1f5184","field":"drug.partd_spending","entity":"drug:vismodegib|erivedge"},{"fact_id":"2d95ce1d9439a3e70ec839b7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50242014001:FL"},{"fact_id":"b76df0cd6acb3a7ae5bac609","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50242014001:NC"},{"fact_id":"452dee39e2aeccf54e614a81","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50242014001:VA"},{"fact_id":"48063677f4cdb7782054eacd","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50242014001:KY"}],"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."}