{"answer":{"query":"Mavenclad","resolved_as":"applications","packages":7,"applications":["NDA022561"],"identity":{"application_numbers":["NDA022561"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2019-04-01","latest":"2019-04-01","packages_with_a_start_date":7}},"generic_entry":[{"application":"NDA022561","date":"2041-09-10","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":"12533408","productNo":"001"},"latest_patent_expiry":"2041-09-10","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":3,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":0,"fact_id":"2d013aedfb12fd2e39262a86"}],"label_history":{"events_total":5,"non_cmc_events":5,"counts_by_class":{"LABELING":5},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA022561","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-05-14","documents":[{"type":"Letter","date":"2026-05-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/022561Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-05-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022561s013lbl.pdf","untrusted":true}}],"fact_id":"84c8c220442588e754aba82b"},{"application":"NDA022561","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-05-10","documents":[{"type":"Letter","date":"2024-05-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022561Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-05-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022561s011lbl.pdf","untrusted":true}}],"fact_id":"4b39eb8fa08b89e3dced9851"},{"application":"NDA022561","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-02-07","documents":[{"type":"Label","date":"2024-02-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022561Orig1s009Corrected_lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-02-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022561Orig1s009Corrected_ltr.pdf","untrusted":true}}],"fact_id":"57a6c0256225bc954c850b45"},{"application":"NDA022561","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-12-06","documents":[{"type":"Letter","date":"2023-12-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022561Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-12-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022561s007lbl.pdf","untrusted":true}}],"fact_id":"b571727caeefaa96abbf0bc8"},{"application":"NDA022561","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-09-19","documents":[{"type":"Letter","date":"2022-09-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022561Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-09-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022561s006lbl.pdf","untrusted":true}}],"fact_id":"d374e5f700917c67e4db6793"}],"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":"NDA022561","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"MAVENCLAD","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"10MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Cladribine","untrusted":true},"brand":{"text":"Mavenclad","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":110753144.44,"claims":1820,"beneficiaries":1037,"average_spending_per_claim_usd":60853.376066,"fact_id":"689967a59200d106087fa7cf"},{"year":2021,"gross_spending_usd":144597434.27,"claims":2182,"beneficiaries":1213,"average_spending_per_claim_usd":66268.301682,"fact_id":"63733aa1d9bb02527d57169d"},{"year":2022,"gross_spending_usd":126761628.54,"claims":1793,"beneficiaries":1006,"average_spending_per_claim_usd":70698.063882,"fact_id":"82ad1ae23a5180cc7a21c0c1"},{"year":2023,"gross_spending_usd":156344543.88,"claims":2078,"beneficiaries":1130,"average_spending_per_claim_usd":75237.990318,"fact_id":"7acf5a6a78a0a82f0c62a476"},{"year":2024,"gross_spending_usd":178190391.8,"claims":2409,"beneficiaries":1315,"average_spending_per_claim_usd":73968.61428,"fact_id":"4474046def4f3c3fd1d22249"}],"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":"Cladribine; cladribine","untrusted":true},"designation_count":7,"approved_count":1,"recent":[{"designated":"2023-06-14","use":{"text":"Treatment of myasthenia gravis","untrusted":true},"status":"Designated","sponsor":{"text":"EMD Serono, Inc.","untrusted":true},"approved":false},{"designated":"2015-03-19","use":{"text":"Treatment of neuromyelitis optica and neuromyelitis optica spectrum disorder","untrusted":true},"status":"Designated","sponsor":{"text":"Chord Therapeutics S.a.r.l.","untrusted":true},"approved":false},{"designated":"1994-04-19","use":{"text":"Treatment of the chronic progressive form of multiple sclerosis.","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Johnson & Johnson Pharmaceutical R & D, LLC","untrusted":true},"approved":false},{"designated":"1993-04-19","use":{"text":"Treatment of non-Hodgkin's lymphoma.","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Janssen Research & Development, LLC","untrusted":true},"approved":false},{"designated":"1990-12-31","use":{"text":"Treatment of chronic lymphocytic leukemia","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Janssen Research & Development, LLC","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"56731d971391b30cc681d4ff"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2024,"states_with_data":0,"all_states_medicaid_reimbursed_usd":0,"all_states_medicaid_paid_prescriptions":0,"top_states":[],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":544,"medicaid_reimbursed_usd":40743236.27,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":5,"facts_fee_for_service_only":4,"older_year_facts_not_used":0,"dataset":"State Drug Utilization Data 2024","read_on":"2026-11-07T23:59:45.983Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). 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":"87369256b35914d789fce334","field":"ndc.listing","entity":"ndc:44087400000"},{"fact_id":"4316f3d6c29804c26f8afb8e","field":"ndc.listing","entity":"ndc:44087400004"},{"fact_id":"b19b78d4dd78b529de2385dd","field":"ndc.listing","entity":"ndc:44087400005"},{"fact_id":"2d013aedfb12fd2e39262a86","field":"drug.generic_entry_earliest","entity":"application:NDA022561"},{"fact_id":"762d4c378f6f5d5999cb4650","field":"drug.patent","entity":"application:NDA022561"},{"fact_id":"84c8c220442588e754aba82b","field":"drug.label_event","entity":"application:NDA022561"},{"fact_id":"4b39eb8fa08b89e3dced9851","field":"drug.label_event","entity":"application:NDA022561"},{"fact_id":"57a6c0256225bc954c850b45","field":"drug.label_event","entity":"application:NDA022561"},{"fact_id":"b571727caeefaa96abbf0bc8","field":"drug.label_event","entity":"application:NDA022561"},{"fact_id":"d374e5f700917c67e4db6793","field":"drug.label_event","entity":"application:NDA022561"},{"fact_id":"d28e4a5adc6c6c0aef1def15","field":"drug.te_code","entity":"application:NDA022561"},{"fact_id":"665e41b3e93ae65b9feaf33e","field":"drug.marketing_status","entity":"application:NDA022561"},{"fact_id":"689967a59200d106087fa7cf","field":"drug.partd_spending","entity":"drug:cladribine|mavenclad"},{"fact_id":"63733aa1d9bb02527d57169d","field":"drug.partd_spending","entity":"drug:cladribine|mavenclad"},{"fact_id":"82ad1ae23a5180cc7a21c0c1","field":"drug.partd_spending","entity":"drug:cladribine|mavenclad"},{"fact_id":"7acf5a6a78a0a82f0c62a476","field":"drug.partd_spending","entity":"drug:cladribine|mavenclad"},{"fact_id":"4474046def4f3c3fd1d22249","field":"drug.partd_spending","entity":"drug:cladribine|mavenclad"},{"fact_id":"56731d971391b30cc681d4ff","field":"drug.orphan_designation","entity":"drug:cladribine"}],"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":"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."}