{"answer":{"query":"Aubagio","resolved_as":"applications","packages":6,"applications":["NDA202992"],"identity":{"application_numbers":["NDA202992"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2013-05-01","latest":"2019-03-28","packages_with_a_start_date":6}},"generic_entry":[{"application":"NDA202992","date":"2034-08-04","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":"9186346*PED","productNo":"001"},"latest_patent_expiry":"2034-08-04","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":12,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":0,"fact_id":"e5ecf2503bdcf046c2b8bca7"}],"label_history":{"events_total":13,"non_cmc_events":13,"counts_by_class":{"LABELING":10,"EFFICACY":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA202992","submission_no":18,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-02-11","documents":[{"type":"Letter","date":"2026-02-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202992Orig1s018ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-02-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/202992s018lbl.pdf","untrusted":true}}],"fact_id":"ea0812e51fca3de7bda9dc79"},{"application":"NDA202992","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-06-10","documents":[{"type":"Letter","date":"2024-06-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202992Orig1s017ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-06-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202992s017lbl.pdf","untrusted":true}}],"fact_id":"876b380554124edbdce13e1b"},{"application":"NDA202992","submission_no":15,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-04-30","documents":[{"type":"Letter","date":"2021-05-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202992Orig1s013, s015ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-05-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202992s013s015lbl.pdf","untrusted":true}}],"fact_id":"ffc571d5e6b75ec61f8914c0"},{"application":"NDA202992","submission_no":13,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-04-30","documents":[{"type":"Letter","date":"2021-05-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202992Orig1s013, s015ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-05-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202992s013s015lbl.pdf","untrusted":true}}],"fact_id":"61df76e3f7403b45c6b9183b"},{"application":"NDA202992","submission_no":14,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-11-06","documents":[{"type":"Label","date":"2020-11-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202992s012s014lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-11-10","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202992Orig1s012, s014ltr.pdf","untrusted":true}}],"fact_id":"3f1d22d699d9df35ca6bab76"}],"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; 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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":"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."}