{"answer":{"query":"Orgovyx","resolved_as":"applications","packages":3,"applications":["NDA214621"],"identity":{"application_numbers":["NDA214621"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2020-12-18","latest":"2023-01-27","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA214621","date":"2037-09-29","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":"10449191","productNo":"001"},"latest_patent_expiry":"2037-09-29","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":12,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":12,"exclusivities_listed":0,"fact_id":"3b771eedcf30a1d5b9968075"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"LABELING":3,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA214621","submission_no":15,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-11-04","documents":[{"type":"Letter","date":"2026-11-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/214621Orig1s015ltr.pdf","untrusted":true}}],"fact_id":"df92056b8df7f4b1f9bb704c"},{"application":"NDA214621","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-10-08","documents":[{"type":"Label","date":"2025-10-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/214621s012lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/214621Orig1s012ltr.pdf","untrusted":true}}],"fact_id":"7366139065bb4ea59896b571"},{"application":"NDA214621","submission_no":6,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-10-18","documents":[{"type":"Letter","date":"2024-10-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/214621Origs006ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-10-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/214621s006lbl.pdf","untrusted":true}}],"fact_id":"5b40d43d9008dd329c006ccf"},{"application":"NDA214621","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-03-30","documents":[{"type":"Letter","date":"2023-03-31","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214621Orig1s004ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-03-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214621s004lbl.pdf","untrusted":true}}],"fact_id":"8313c058cac46d36001d242c"}],"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":"NDA214621","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ORGOVYX","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"120MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Relugolix","untrusted":true},"brand":{"text":"Orgovyx","untrusted":true}},"latest_year":2024,"series":[{"year":2021,"gross_spending_usd":51999804.16,"claims":21283,"beneficiaries":4781,"average_spending_per_claim_usd":2443.2553757,"fact_id":"6cff8e5d17daee8e6728af08"},{"year":2022,"gross_spending_usd":165989469.68,"claims":63553,"beneficiaries":10466,"average_spending_per_claim_usd":2611.8274461,"fact_id":"00c6438a2fb3c1a60f859210"},{"year":2023,"gross_spending_usd":276597251.91,"claims":100329,"beneficiaries":15958,"average_spending_per_claim_usd":2756.9023105,"fact_id":"5f414d76c11676d51d250bbb"},{"year":2024,"gross_spending_usd":484308516.16,"claims":180761,"beneficiaries":28521,"average_spending_per_claim_usd":2679.2754862,"fact_id":"8800069ba00274e8e1565c9c"}],"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":2,"all_states_medicaid_reimbursed_usd":790691.83,"all_states_medicaid_paid_prescriptions":299,"top_states":[{"state":"KY","medicaid_paid_prescriptions":239,"medicaid_reimbursed_usd":613252.59,"total_reimbursed_usd":613252.59,"packages":1,"covers":"all_record_types","fact_id":"6e646652de9659ec2fb24db5"},{"state":"HI","medicaid_paid_prescriptions":60,"medicaid_reimbursed_usd":177439.24,"total_reimbursed_usd":177439.24,"packages":1,"covers":"all_record_types","fact_id":"503d66ae354bdca722cfa664"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":0,"older_year_facts_not_used":23,"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). 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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":"403bcf921add2e90e3db3108","field":"ndc.listing","entity":"ndc:72974012001"},{"fact_id":"c81d58584c4fdd9d57fe9abc","field":"ndc.listing","entity":"ndc:72974012095"},{"fact_id":"2054060e46bb17d741ec1b47","field":"ndc.listing","entity":"ndc:72974012097"},{"fact_id":"3b771eedcf30a1d5b9968075","field":"drug.generic_entry_earliest","entity":"application:NDA214621"},{"fact_id":"f1db8f8b1edec784fddf649c","field":"drug.patent","entity":"application:NDA214621"},{"fact_id":"df92056b8df7f4b1f9bb704c","field":"drug.label_event","entity":"application:NDA214621"},{"fact_id":"7366139065bb4ea59896b571","field":"drug.label_event","entity":"application:NDA214621"},{"fact_id":"5b40d43d9008dd329c006ccf","field":"drug.label_event","entity":"application:NDA214621"},{"fact_id":"8313c058cac46d36001d242c","field":"drug.label_event","entity":"application:NDA214621"},{"fact_id":"35c8a37ac43c9b5a5079aa15","field":"drug.marketing_status","entity":"application:NDA214621"},{"fact_id":"6cff8e5d17daee8e6728af08","field":"drug.partd_spending","entity":"drug:relugolix|orgovyx"},{"fact_id":"00c6438a2fb3c1a60f859210","field":"drug.partd_spending","entity":"drug:relugolix|orgovyx"},{"fact_id":"5f414d76c11676d51d250bbb","field":"drug.partd_spending","entity":"drug:relugolix|orgovyx"},{"fact_id":"8800069ba00274e8e1565c9c","field":"drug.partd_spending","entity":"drug:relugolix|orgovyx"},{"fact_id":"6e646652de9659ec2fb24db5","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72974012001:KY"},{"fact_id":"503d66ae354bdca722cfa664","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72974012001:HI"}],"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."}