{"answer":{"query":"Revlimid","resolved_as":"applications","packages":12,"applications":["NDA021880"],"identity":{"application_numbers":["NDA021880"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2005-12-27","latest":"2013-06-10","packages_with_a_start_date":12}},"generic_entry":[{"application":"NDA021880","date":"2028-03-08","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":"8741929","productNo":"004"},"latest_patent_expiry":"2028-03-08","latest_exclusivity_expiry":"2026-05-28","dated_barriers":24,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":2,"fact_id":"4583372aa8bd64de445395fa"}],"label_history":{"events_total":38,"non_cmc_events":37,"counts_by_class":{"LABELING":16,"REMS":13,"EFFICACY":8},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA021880","submission_no":70,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-07-22","documents":[{"type":"Letter","date":"2026-07-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021880Orig1s070ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-07-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021880Orig1s070lbl.pdf","untrusted":true}}],"fact_id":"247035274104e52874dfde92"},{"application":"NDA021880","submission_no":69,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2026-04-27","documents":[{"type":"Letter","date":"2026-05-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021880Orig1s069ltr.pdf","untrusted":true}}],"fact_id":"c8c2ddc7c4058cc0e3a3e426"},{"application":"NDA021880","submission_no":67,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2023-03-24","documents":[{"type":"Letter","date":"2023-03-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021880Orig1s067ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-03-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021880s067lbl.pdf","untrusted":true}}],"fact_id":"d3274f6e2cb0ba53508357d4"},{"application":"NDA021880","submission_no":65,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-05-24","documents":[{"type":"Label","date":"2022-05-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021880s065lbl.pdf","untrusted":true}},{"type":"Letter","date":"2022-05-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021880Orig1s065ltr.pdf","untrusted":true}}],"fact_id":"00f028550d48c4671fc2d10b"},{"application":"NDA021880","submission_no":64,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-08-31","documents":[{"type":"Letter","date":"2021-09-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021880Orig1s064_REPLACEMENT_ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-09-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021880Orig1s064lbledt.pdf","untrusted":true}}],"fact_id":"90d1bf0d4ea01eb51cd71031"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":6,"te_code_counts":{"AB":6},"marketing_status_counts":{"Prescription":6},"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":"NDA021880","product_no":"005","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"REVLIMID","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"2.5MG","untrusted":true}},{"application":"NDA021880","product_no":"004","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"REVLIMID","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"25MG","untrusted":true}},{"application":"NDA021880","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"REVLIMID","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"15MG","untrusted":true}},{"application":"NDA021880","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"REVLIMID","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"5MG","untrusted":true}},{"application":"NDA021880","product_no":"006","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"REVLIMID","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"20MG","untrusted":true}},{"application":"NDA021880","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"REVLIMID","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"10MG","untrusted":true}}]},"recalls":{"recalls_total":5,"counts_by_class":{"Class II":5},"packages_of_these_applications":12,"most_recent":[{"recall_number":"D-0771-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"e7a72bd0622e42d7b6096b13"},{"recall_number":"D-0772-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"351d8c172b8043bae542c279"},{"recall_number":"D-0773-2018","classification":"Class II","status":"Terminated","report_date":"2018-05-16","recall_initiated":"2018-04-03","recalling_firm":{"text":"Kroger Specialty Pharmacy, Inc.","untrusted":true},"reason":{"text":"Lack of Processing Controls.","untrusted":true},"packages_named":1,"fact_id":"63cbe7bab67aa32a9e6c08a1"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Lenalidomide","untrusted":true},"brand":{"text":"Revlimid","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":5356050274.6,"claims":329864,"beneficiaries":43747,"average_spending_per_claim_usd":16237.14705,"fact_id":"83d94281ef9300408a46ce4c"},{"year":2021,"gross_spending_usd":5893547689,"claims":344297,"beneficiaries":45601,"average_spending_per_claim_usd":17117.627191,"fact_id":"ba3faeb083aeb7cfd1820c2c"},{"year":2022,"gross_spending_usd":5935051092.4,"claims":329329,"beneficiaries":45557,"average_spending_per_claim_usd":18021.647327,"fact_id":"3d7ee1995a4d520bc17eef23"},{"year":2023,"gross_spending_usd":3859804788.6,"claims":216207,"beneficiaries":36967,"average_spending_per_claim_usd":17852.358104,"fact_id":"28d7947f4ff14271f6ed2bb8"},{"year":2024,"gross_spending_usd":4179511486.3,"claims":239843,"beneficiaries":38868,"average_spending_per_claim_usd":17426.030721,"fact_id":"d408c6c7a3d471c512c61508"}],"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":"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":"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":"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."}