{"answer":{"query":"Korlym","resolved_as":"applications","packages":3,"applications":["NDA202107"],"identity":{"application_numbers":["NDA202107"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2012-02-17","latest":"2024-05-28","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA202107","date":"2038-08-22","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":"10231983","productNo":"001"},"latest_patent_expiry":"2038-08-22","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":18,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":18,"exclusivities_listed":0,"fact_id":"4fc8d5eed08eae5aa208b26b"}],"label_history":{"events_total":7,"non_cmc_events":3,"counts_by_class":{"LABELING":3},"cmc_events":4,"recent_non_cmc_events":[{"application":"NDA202107","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-11-05","documents":[{"type":"Letter","date":"2019-11-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202107Orig1s008ltr.pdf","untrusted":true}},{"type":"Label","date":"2019-12-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202107s008lbl.pdf","untrusted":true}}],"fact_id":"fd0196c080cefed60f0770ee"},{"application":"NDA202107","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-05-16","documents":[{"type":"Label","date":"2017-05-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-05-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202107Orig1s007ltr.pdf","untrusted":true}}],"fact_id":"0f21928c1461063402f7e479"},{"application":"NDA202107","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-10-25","documents":[{"type":"Letter","date":"2016-10-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202107Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2016-11-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202107s006lbl.pdf","untrusted":true}}],"fact_id":"c66f8b9f19cdc851cd1dd541"}],"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":{"AB":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":"NDA202107","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"KORLYM","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"300MG","untrusted":true}}]},"policy":{"events_matching":1,"recent":[{"document_number":"2026-17991","document_type":"Notice","publication_date":"2026-09-02","effective_date":null,"title":{"text":"Prospective Grant of an Exclusive Patent License: Development and Commercialization of Mifepristone and Analogues To Treat Hypercortisolism-Related Insulin Resistance Disorders","untrusted":true},"link":{"text":"https://www.federalregister.gov/documents/2026/09/02/2026-17991/prospective-grant-of-an-exclusive-patent-license-development-and-commercialization-of-mifepristone","untrusted":true},"matched_on":["mifepristone"],"fact_id":"31c059e03559173139d91a31"}],"note":"Federal Register documents that name the drug or one of its programs: a dated record of what was published, not a reading of its legal effect"},"spending":{"reported_under":{"generic":{"text":"Mifepristone","untrusted":true},"brand":{"text":"Korlym","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":153690298.69,"claims":5261,"beneficiaries":729,"average_spending_per_claim_usd":29213.134136,"fact_id":"63c36ed35c1f13bab6731b51"},{"year":2021,"gross_spending_usd":165795595.2,"claims":5625,"beneficiaries":816,"average_spending_per_claim_usd":29474.77248,"fact_id":"871703c4d3f216b0646c78b4"},{"year":2022,"gross_spending_usd":187312598.48,"claims":6080,"beneficiaries":846,"average_spending_per_claim_usd":30807.993171,"fact_id":"7925ce6ea4e3c29ce9c68e70"},{"year":2023,"gross_spending_usd":228814733.76,"claims":6956,"beneficiaries":1059,"average_spending_per_claim_usd":32894.585072,"fact_id":"d5130cf18b7eb49d14f646c7"},{"year":2024,"gross_spending_usd":341766724.98,"claims":10079,"beneficiaries":1700,"average_spending_per_claim_usd":33908.793033,"fact_id":"27e7c8fb54964cd853b02b2e"}],"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":"Mifepristone; mifepristone","untrusted":true},"designation_count":3,"approved_count":1,"recent":[{"designated":"2016-01-14","use":{"text":"Treatment of ovarian cancer.","untrusted":true},"status":"Designated","sponsor":{"text":"Corcept Therapeutics, Inc.","untrusted":true},"approved":false},{"designated":"2007-07-05","use":{"text":"Treatment of the clinical manifestations of endogenous Cushing's syndrone","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Corcept Therapeutics, Inc.","untrusted":true},"approved":true},{"designated":"2005-02-07","use":{"text":"Treatment of Cushing's syndrome secondary to ectopic ACTH secretion","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"HRA Pharma","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"dbaa94d8e12323617b54ef82"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; 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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. 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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":"AMBIGUOUS","field":"spending","reason":"2 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"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."}