{"answer":{"query":"Nubeqa","resolved_as":"applications","packages":2,"applications":["NDA212099"],"identity":{"application_numbers":["NDA212099"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2019-07-31","latest":"2021-03-03","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA212099","date":"2042-06-17","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":"12329742","productNo":"001"},"latest_patent_expiry":"2042-06-17","latest_exclusivity_expiry":"2028-06-03","dated_barriers":11,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":10,"exclusivities_listed":1,"fact_id":"085166e01dee3b0d8e504686"}],"label_history":{"events_total":5,"non_cmc_events":5,"counts_by_class":{"LABELING":2,"EFFICACY":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA212099","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-09-22","documents":[{"type":"Letter","date":"2026-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/212099Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/212099s016lbl.pdf","untrusted":true}}],"fact_id":"a5db1217de85e929a2845d7a"},{"application":"NDA212099","submission_no":8,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-06-03","documents":[{"type":"Letter","date":"2025-06-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/212099Orig1s008ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-06-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212099s008lbl.pdf","untrusted":true}}],"fact_id":"4ceaab9ad5056a4f41af6273"},{"application":"NDA212099","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-10-13","documents":[{"type":"Label","date":"2023-10-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212099s004lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-10-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/212099Orig1s004ltr.pdf","untrusted":true}}],"fact_id":"b3fb074b05ff238dccda579b"},{"application":"NDA212099","submission_no":2,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-08-05","documents":[{"type":"Letter","date":"2022-08-08","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212099Orig1s002ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-08-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212099s002lbl.pdf","untrusted":true}}],"fact_id":"60178b91a94de65b6acfbbdc"},{"application":"NDA212099","submission_no":1,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-01-07","documents":[{"type":"Letter","date":"2021-01-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212099Orig1s001ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-01-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212099s001lbl.pdf","untrusted":true}}],"fact_id":"c1f1e2e0cafa0638379aa3ac"}],"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":"NDA212099","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"NUBEQA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"300MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Darolutamide","untrusted":true},"brand":{"text":"Nubeqa","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":99928016.37,"claims":8593,"beneficiaries":1651,"average_spending_per_claim_usd":11629.002254,"fact_id":"be2c418d6946e126db03e44e"},{"year":2021,"gross_spending_usd":223521255.88,"claims":18663,"beneficiaries":2996,"average_spending_per_claim_usd":11976.705561,"fact_id":"48189fb9c0be81655a2a141f"},{"year":2022,"gross_spending_usd":322342011.26,"claims":26002,"beneficiaries":4434,"average_spending_per_claim_usd":12396.816063,"fact_id":"920027130abdb05e89117207"},{"year":2023,"gross_spending_usd":576350298.79,"claims":43925,"beneficiaries":7174,"average_spending_per_claim_usd":13121.236171,"fact_id":"bb1822be35500b7e267c3933"},{"year":2024,"gross_spending_usd":998066130.12,"claims":78077,"beneficiaries":11577,"average_spending_per_claim_usd":12783.100402,"fact_id":"4ec29e0ccc11e4870e68480a"}],"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; 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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."}