{"answer":{"query":"Vumerity","resolved_as":"applications","packages":2,"applications":["NDA211855"],"identity":{"application_numbers":["NDA211855"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2019-10-29","latest":"2022-09-01","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA211855","date":"2033-10-29","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":"8669281","productNo":"001"},"latest_patent_expiry":"2033-10-29","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":3,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":0,"fact_id":"a8e5f6265d44ccd69c708080"}],"label_history":{"events_total":9,"non_cmc_events":7,"counts_by_class":{"LABELING":6,"EFFICACY":1},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA211855","submission_no":15,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-03-22","documents":[{"type":"Label","date":"2024-03-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211855s015lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-03-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211855Orig1s015ltr.pdf","untrusted":true}}],"fact_id":"87d497b5e07ff224ded9e614"},{"application":"NDA211855","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-12-13","documents":[{"type":"Letter","date":"2023-12-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211855Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-12-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211855s016lbl.pdf","untrusted":true}}],"fact_id":"c6c9f1273ccbbc59b27f2a61"},{"application":"NDA211855","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-02-10","documents":[{"type":"Letter","date":"2023-02-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211855Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-02-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211855s009lbl.pdf","untrusted":true}}],"fact_id":"35dbb116a07a8cf30e4ce950"},{"application":"NDA211855","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-09-29","documents":[{"type":"Letter","date":"2022-09-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211855Orig1s010ltr.pdf","untrusted":true}},{"type":"Letter","date":"2022-10-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211855s010lbl.pdf","untrusted":true}},{"type":"Label","date":"2022-10-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855s010lbl.pdf","untrusted":true}}],"fact_id":"ba99a141dd3052be3b3036e3"},{"application":"NDA211855","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-02-10","documents":[{"type":"Label","date":"2022-02-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211855s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2022-02-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211855Orig1s006ltr.pdf","untrusted":true}}],"fact_id":"acca83d5a4d094911cf331a8"}],"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":"NDA211855","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VUMERITY","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"231MG","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":2,"most_recent":[{"recall_number":"D-0148-2021","classification":"Class II","status":"Terminated","report_date":"2020-12-23","recall_initiated":"2020-12-09","recalling_firm":{"text":"Biogen MA Inc.","untrusted":true},"reason":{"text":"Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing.","untrusted":true},"packages_named":2,"fact_id":"5f7afd086e0a233ab6d102e7"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Diroximel Fumarate","untrusted":true},"brand":{"text":"Vumerity","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":16976972.21,"claims":1988,"beneficiaries":668,"average_spending_per_claim_usd":8539.7244517,"fact_id":"9f0c5d44c71fca5e5744e8d8"},{"year":2021,"gross_spending_usd":99890636.84,"claims":10949,"beneficiaries":1996,"average_spending_per_claim_usd":9123.2657631,"fact_id":"dc0d8e6cf2c298d710a094cb"},{"year":2022,"gross_spending_usd":119582404.48,"claims":13045,"beneficiaries":2050,"average_spending_per_claim_usd":9166.9148701,"fact_id":"32dce8490c04a57210a2c555"},{"year":2023,"gross_spending_usd":152400688.76,"claims":16568,"beneficiaries":2304,"average_spending_per_claim_usd":9198.4964244,"fact_id":"d358e3da67e38d5e57bf879c"},{"year":2024,"gross_spending_usd":189805009.17,"claims":21014,"beneficiaries":2762,"average_spending_per_claim_usd":9032.3122285,"fact_id":"aba0b5a5b646797ede99944b"}],"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":3,"all_states_medicaid_reimbursed_usd":1613505.14,"all_states_medicaid_paid_prescriptions":179,"top_states":[{"state":"IA","medicaid_paid_prescriptions":74,"medicaid_reimbursed_usd":665190.36,"total_reimbursed_usd":665190.36,"packages":1,"covers":"all_record_types","fact_id":"fffb6c58c66f9693c3eedea6"},{"state":"OR","medicaid_paid_prescriptions":55,"medicaid_reimbursed_usd":498984.58,"total_reimbursed_usd":498984.58,"packages":1,"covers":"fee_for_service_only","fact_id":"b290c454dbb0adf563447450"},{"state":"SD","medicaid_paid_prescriptions":50,"medicaid_reimbursed_usd":449330.2,"total_reimbursed_usd":449330.2,"packages":1,"covers":"all_record_types","fact_id":"251577319e67805977043ddf"}],"unlabelled_state_code_xx":null,"built_from_facts":3,"facts_fee_for_service_only":1,"older_year_facts_not_used":27,"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). 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":"80b0346a8e9db0228ae236d1","field":"ndc.listing","entity":"ndc:64406002003"},{"fact_id":"a7cec9c2d302831eac96ec68","field":"ndc.listing","entity":"ndc:64406002007"},{"fact_id":"a8e5f6265d44ccd69c708080","field":"drug.generic_entry_earliest","entity":"application:NDA211855"},{"fact_id":"4a8922366697790c2e186ccd","field":"drug.patent","entity":"application:NDA211855"},{"fact_id":"87d497b5e07ff224ded9e614","field":"drug.label_event","entity":"application:NDA211855"},{"fact_id":"c6c9f1273ccbbc59b27f2a61","field":"drug.label_event","entity":"application:NDA211855"},{"fact_id":"35dbb116a07a8cf30e4ce950","field":"drug.label_event","entity":"application:NDA211855"},{"fact_id":"ba99a141dd3052be3b3036e3","field":"drug.label_event","entity":"application:NDA211855"},{"fact_id":"acca83d5a4d094911cf331a8","field":"drug.label_event","entity":"application:NDA211855"},{"fact_id":"2ec246dc15b30a33ffcff507","field":"drug.te_code","entity":"application:NDA211855"},{"fact_id":"6dfc41dc97a3fe1fb52bf3bc","field":"drug.marketing_status","entity":"application:NDA211855"},{"fact_id":"5f7afd086e0a233ab6d102e7","field":"ndc.recall","entity":"ndc:64406002003"},{"fact_id":"9f0c5d44c71fca5e5744e8d8","field":"drug.partd_spending","entity":"drug:diroximel-fumarate|vumerity"},{"fact_id":"dc0d8e6cf2c298d710a094cb","field":"drug.partd_spending","entity":"drug:diroximel-fumarate|vumerity"},{"fact_id":"32dce8490c04a57210a2c555","field":"drug.partd_spending","entity":"drug:diroximel-fumarate|vumerity"},{"fact_id":"d358e3da67e38d5e57bf879c","field":"drug.partd_spending","entity":"drug:diroximel-fumarate|vumerity"},{"fact_id":"aba0b5a5b646797ede99944b","field":"drug.partd_spending","entity":"drug:diroximel-fumarate|vumerity"},{"fact_id":"fffb6c58c66f9693c3eedea6","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64406002003:IA"},{"fact_id":"b290c454dbb0adf563447450","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64406002003:OR"},{"fact_id":"251577319e67805977043ddf","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64406002003:SD"}],"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":"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."}