{"answer":{"query":"Tecfidera","resolved_as":"applications","packages":3,"applications":["NDA204063"],"identity":{"application_numbers":["NDA204063"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true},{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2013-03-27","latest":"2013-03-27","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA204063","date":"2035-11-16","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":"10959972","productNo":"001"},"latest_patent_expiry":"2035-11-16","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":18,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":9,"exclusivities_listed":0,"fact_id":"a01376a24df389be004ce77c"}],"label_history":{"events_total":24,"non_cmc_events":17,"counts_by_class":{"LABELING":14,"EFFICACY":3},"cmc_events":7,"recent_non_cmc_events":[{"application":"NDA204063","submission_no":31,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-03-12","documents":[{"type":"Label","date":"2024-03-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204063s031lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-03-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204063Orig1s031ltr.pdf","untrusted":true}}],"fact_id":"5bff624e608aea70608022bb"},{"application":"NDA204063","submission_no":32,"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/2023/204063Orig1s032ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-12-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204063s032lbl.pdf","untrusted":true}}],"fact_id":"87d5d10a319aae8dfc3f5bb9"},{"application":"NDA204063","submission_no":29,"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/2023/204063Orig1s029ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-02-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204063s029lbl.pdf","untrusted":true}}],"fact_id":"3bd6cf3375591b85cf50cab6"},{"application":"NDA204063","submission_no":30,"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/2022/204063Orig1s028, s030ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-10-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204063s028s030lbl.pdf","untrusted":true}}],"fact_id":"d7d503c16885d100c2da0ea2"},{"application":"NDA204063","submission_no":28,"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/2022/204063Orig1s028, s030ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-10-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204063s028s030lbl.pdf","untrusted":true}}],"fact_id":"8076b3ff101469bece99ac23"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"AB":2},"marketing_status_counts":{"Prescription":2},"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":"NDA204063","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TECFIDERA","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"120MG","untrusted":true}},{"application":"NDA204063","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"TECFIDERA","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"240MG","untrusted":true}}]},"recalls":{"recalls_total":2,"counts_by_class":{"Class III":1,"Class II":1},"packages_of_these_applications":3,"most_recent":[{"recall_number":"D-1381-2020","classification":"Class III","status":"Terminated","report_date":"2020-07-15","recall_initiated":"2020-06-23","recalling_firm":{"text":"Biogen MA Inc.","untrusted":true},"reason":{"text":"cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.","untrusted":true},"packages_named":1,"fact_id":"4bb25963405057f608277d0e"},{"recall_number":"D-0767-2018","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":"8b53186fda7537c06e756a2c"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Dimethyl Fumarate","untrusted":true},"brand":{"text":"Tecfidera","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":1054984601.4,"claims":108629,"beneficiaries":14663,"average_spending_per_claim_usd":9711.8136169,"fact_id":"b56608a6f806ce0ad9c45ebc"},{"year":2021,"gross_spending_usd":569199652.82,"claims":63761,"beneficiaries":8187,"average_spending_per_claim_usd":8927.0816458,"fact_id":"360d2c7fa266329519eb7284"},{"year":2022,"gross_spending_usd":343225606.51,"claims":38126,"beneficiaries":4651,"average_spending_per_claim_usd":9002.4027307,"fact_id":"bb6d8b00ccea774b79b0e754"},{"year":2023,"gross_spending_usd":234518995.77,"claims":23080,"beneficiaries":3154,"average_spending_per_claim_usd":10161.134999,"fact_id":"1888e316236d56f304189573"},{"year":2024,"gross_spending_usd":162842334.66,"claims":16641,"beneficiaries":2117,"average_spending_per_claim_usd":9785.6099189,"fact_id":"8d99b7d00f5324babee73338"}],"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":2024,"states_with_data":14,"all_states_medicaid_reimbursed_usd":20267057.24,"all_states_medicaid_paid_prescriptions":2192,"top_states":[{"state":"IL","medicaid_paid_prescriptions":757,"medicaid_reimbursed_usd":6569521.38,"total_reimbursed_usd":6569521.38,"packages":1,"covers":"fee_for_service_only","fact_id":"f9b704e17993a0755cda349b"},{"state":"MI","medicaid_paid_prescriptions":241,"medicaid_reimbursed_usd":2180853.26,"total_reimbursed_usd":2180853.26,"packages":1,"covers":"fee_for_service_only","fact_id":"305542fa97acf177a79568b0"},{"state":"NY","medicaid_paid_prescriptions":183,"medicaid_reimbursed_usd":2035861.63,"total_reimbursed_usd":2035861.63,"packages":1,"covers":"all_record_types","fact_id":"62a964767790b390450b2550"},{"state":"PA","medicaid_paid_prescriptions":178,"medicaid_reimbursed_usd":1550712.46,"total_reimbursed_usd":1550712.46,"packages":1,"covers":"all_record_types","fact_id":"1c464eba1797b24fc5279e31"},{"state":"CA","medicaid_paid_prescriptions":111,"medicaid_reimbursed_usd":1160541.9,"total_reimbursed_usd":1176637.68,"packages":1,"covers":"all_record_types","fact_id":"b1aeebc96ac88c4b2169048f"},{"state":"NC","medicaid_paid_prescriptions":105,"medicaid_reimbursed_usd":1086827.6,"total_reimbursed_usd":1086827.6,"packages":1,"covers":"fee_for_service_only","fact_id":"0d7e435d4c578f918bcd7182"},{"state":"OH","medicaid_paid_prescriptions":106,"medicaid_reimbursed_usd":969092.41,"total_reimbursed_usd":969092.41,"packages":1,"covers":"fee_for_service_only","fact_id":"7471892ebef60488a4bf10b9"},{"state":"TX","medicaid_paid_prescriptions":85,"medicaid_reimbursed_usd":776413.56,"total_reimbursed_usd":776413.56,"packages":1,"covers":"all_record_types","fact_id":"c6179f63688a79eb872416a6"},{"state":"MA","medicaid_paid_prescriptions":81,"medicaid_reimbursed_usd":765724.13,"total_reimbursed_usd":765724.13,"packages":1,"covers":"fee_for_service_only","fact_id":"1269b2771619595cefa1c3d7"},{"state":"VA","medicaid_paid_prescriptions":83,"medicaid_reimbursed_usd":736505.55,"total_reimbursed_usd":752595.83,"packages":1,"covers":"all_record_types","fact_id":"8fbc47352e6d0d0e6e63b0cc"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":2905,"medicaid_reimbursed_usd":26499548.04,"note":"the source uses the code XX without defining it; 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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":"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."}