{"answer":{"query":"Orserdu","resolved_as":"applications","packages":2,"applications":["NDA217639"],"identity":{"application_numbers":["NDA217639"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2023-01-27","latest":"2023-01-27","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA217639","date":"2038-01-05","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":"10385008","productNo":"001"},"latest_patent_expiry":"2038-01-05","latest_exclusivity_expiry":"2028-01-27","dated_barriers":16,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":1,"fact_id":"8b6df2070e2f7782eb75610d"}],"label_history":{"events_total":2,"non_cmc_events":2,"counts_by_class":{"LABELING":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA217639","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-24","documents":[{"type":"Letter","date":"2026-06-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/217639Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217639s007lbl.pdf","untrusted":true}}],"fact_id":"fffd0a4ae5095fbd435fc21c"},{"application":"NDA217639","submission_no":1,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-11-09","documents":[{"type":"Letter","date":"2023-11-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/217639Orig1s001ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-02-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/217639Orig1s001correctedlbl.pdf","untrusted":true}}],"fact_id":"16535ad9157110101d357e40"}],"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":"NDA217639","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ORSERDU","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 345MG BASE","untrusted":true}},{"application":"NDA217639","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ORSERDU","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 86MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Elacestrant HCl","untrusted":true},"brand":{"text":"Orserdu","untrusted":true}},"latest_year":2024,"series":[{"year":2023,"gross_spending_usd":127626022.26,"claims":5746,"beneficiaries":1640,"average_spending_per_claim_usd":22211.281284,"fact_id":"78bec46922680281961f4fd5"},{"year":2024,"gross_spending_usd":258846197.93,"claims":11378,"beneficiaries":2633,"average_spending_per_claim_usd":22749.709785,"fact_id":"1efbbb3f217253277a0ffb1d"}],"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":2024,"states_with_data":4,"all_states_medicaid_reimbursed_usd":11634427.25,"all_states_medicaid_paid_prescriptions":513,"top_states":[{"state":"CA","medicaid_paid_prescriptions":173,"medicaid_reimbursed_usd":4056669.99,"total_reimbursed_usd":4099395,"packages":1,"covers":"all_record_types","fact_id":"fcea244585672ea14d6cff67"},{"state":"NY","medicaid_paid_prescriptions":177,"medicaid_reimbursed_usd":3971955.04,"total_reimbursed_usd":3971955.04,"packages":1,"covers":"all_record_types","fact_id":"6ce5f5cce9a799984298f111"},{"state":"TX","medicaid_paid_prescriptions":83,"medicaid_reimbursed_usd":1843863.66,"total_reimbursed_usd":1843863.66,"packages":1,"covers":"all_record_types","fact_id":"9460d578c71f65a358162f4f"},{"state":"PA","medicaid_paid_prescriptions":80,"medicaid_reimbursed_usd":1761938.56,"total_reimbursed_usd":1761938.56,"packages":1,"covers":"all_record_types","fact_id":"e7049c9102d3895fdf52c313"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":1549,"medicaid_reimbursed_usd":34342557.41,"note":"the source uses the code XX without defining it; 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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":"ec66b3a1014cf0552f5b2fd0","field":"ndc.listing","entity":"ndc:72187010103"},{"fact_id":"8a9f8524c7703b8f2131bf91","field":"ndc.listing","entity":"ndc:72187010203"},{"fact_id":"8b6df2070e2f7782eb75610d","field":"drug.generic_entry_earliest","entity":"application:NDA217639"},{"fact_id":"5f8043f7f4fbd1e8922d4491","field":"drug.patent","entity":"application:NDA217639"},{"fact_id":"1af3de7759f8ba05a879a1a6","field":"drug.exclusivity","entity":"application:NDA217639"},{"fact_id":"fffd0a4ae5095fbd435fc21c","field":"drug.label_event","entity":"application:NDA217639"},{"fact_id":"16535ad9157110101d357e40","field":"drug.label_event","entity":"application:NDA217639"},{"fact_id":"f99193da1ef96e3941ac2fa5","field":"drug.marketing_status","entity":"application:NDA217639"},{"fact_id":"b1c2060ea290d7a60144f629","field":"drug.marketing_status","entity":"application:NDA217639"},{"fact_id":"78bec46922680281961f4fd5","field":"drug.partd_spending","entity":"drug:elacestrant-hcl|orserdu"},{"fact_id":"1efbbb3f217253277a0ffb1d","field":"drug.partd_spending","entity":"drug:elacestrant-hcl|orserdu"},{"fact_id":"fcea244585672ea14d6cff67","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72187010203:CA"},{"fact_id":"6ce5f5cce9a799984298f111","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72187010203:NY"},{"fact_id":"9460d578c71f65a358162f4f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72187010203:TX"},{"fact_id":"e7049c9102d3895fdf52c313","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72187010203:PA"}],"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."}