{"answer":{"query":"Jublia","resolved_as":"applications","packages":3,"applications":["NDA203567"],"identity":{"application_numbers":["NDA203567"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2014-06-06","latest":"2015-12-17","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA203567","date":"2035-04-25","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":"10478601","productNo":"001"},"latest_patent_expiry":"2035-04-25","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":18,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":18,"exclusivities_listed":0,"fact_id":"687ce6b79464ce462a7e316e"}],"label_history":{"events_total":7,"non_cmc_events":4,"counts_by_class":{"LABELING":3,"EFFICACY":1},"cmc_events":3,"recent_non_cmc_events":[{"application":"NDA203567","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-03-31","documents":[{"type":"Letter","date":"2022-04-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/203567Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-04-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/203567s010lbl.pdf","untrusted":true}}],"fact_id":"2b4bf195f4aa8ea7e43e7d19"},{"application":"NDA203567","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2020-04-26","documents":[{"type":"Letter","date":"2020-04-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/203567Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-04-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/203567s009lbl.pdf","untrusted":true}}],"fact_id":"f212637ffd3b18233b1c89ad"},{"application":"NDA203567","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-09-22","documents":[{"type":"Label","date":"2016-09-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203567s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2016-10-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203567Orig1s006ltr.pdf","untrusted":true}}],"fact_id":"cdab97d6d95505a248c6b222"},{"application":"NDA203567","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2015-02-27","documents":[{"type":"Label","date":"2015-03-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203567s002lbl.pdf","untrusted":true}},{"type":"Letter","date":"2015-03-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/203567Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"bbc64ad63aa1ee9977f1bf87"}],"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":"NDA203567","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"JUBLIA","untrusted":true},"form":{"text":"SOLUTION;TOPICAL","untrusted":true},"strength":{"text":"10%","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Efinaconazole","untrusted":true},"brand":{"text":"Jublia","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":41729297.16,"claims":42936,"beneficiaries":16987,"average_spending_per_claim_usd":971.89531302,"fact_id":"791a1b1c9e0fc9e10199a5c5"},{"year":2021,"gross_spending_usd":50336999.13,"claims":48988,"beneficiaries":18985,"average_spending_per_claim_usd":1027.5373383,"fact_id":"9cbc26e93002764f0ce7d7e8"},{"year":2022,"gross_spending_usd":69225105.1,"claims":62830,"beneficiaries":24361,"average_spending_per_claim_usd":1101.7842607,"fact_id":"99c727be472fb47f2bb38c78"},{"year":2023,"gross_spending_usd":93684777.25,"claims":76494,"beneficiaries":28671,"average_spending_per_claim_usd":1224.7336687,"fact_id":"7d72dff0194e9aa4abebc31f"},{"year":2024,"gross_spending_usd":118601786.17,"claims":101398,"beneficiaries":35400,"average_spending_per_claim_usd":1169.665932,"fact_id":"05736a6a020eeade8fc21cf9"}],"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":22,"all_states_medicaid_reimbursed_usd":23503520.41,"all_states_medicaid_paid_prescriptions":24026,"top_states":[{"state":"NY","medicaid_paid_prescriptions":18155,"medicaid_reimbursed_usd":17963817.35,"total_reimbursed_usd":17984445.15,"packages":2,"covers":"fee_for_service_only","fact_id":"a4f21e891366c5c751a78be5"},{"state":"CT","medicaid_paid_prescriptions":1191,"medicaid_reimbursed_usd":1286198.01,"total_reimbursed_usd":1286460.48,"packages":2,"covers":"all_record_types","fact_id":"a30cb41c596357d0a662a112"},{"state":"CO","medicaid_paid_prescriptions":1182,"medicaid_reimbursed_usd":1187316.39,"total_reimbursed_usd":1187988.64,"packages":2,"covers":"fee_for_service_only","fact_id":"51e0aad693dcb7011ffe1f8f"},{"state":"IN","medicaid_paid_prescriptions":761,"medicaid_reimbursed_usd":800873.68,"total_reimbursed_usd":801654.28,"packages":2,"covers":"fee_for_service_only","fact_id":"e4ea00f0b0d0ee78fca4340d"},{"state":"PA","medicaid_paid_prescriptions":351,"medicaid_reimbursed_usd":348432.74,"total_reimbursed_usd":383337.64,"packages":2,"covers":"fee_for_service_only","fact_id":"5db65bac1f96ad20391be3b6"},{"state":"MA","medicaid_paid_prescriptions":251,"medicaid_reimbursed_usd":290496.5,"total_reimbursed_usd":290496.5,"packages":2,"covers":"fee_for_service_only","fact_id":"14c6d68012876e644d0b0cfa"},{"state":"WA","medicaid_paid_prescriptions":245,"medicaid_reimbursed_usd":231706.7,"total_reimbursed_usd":242116.11,"packages":2,"covers":"all_record_types","fact_id":"600c30196109e227cdf4f586"},{"state":"VA","medicaid_paid_prescriptions":294,"medicaid_reimbursed_usd":208183.62,"total_reimbursed_usd":222725.2,"packages":1,"covers":"fee_for_service_only","fact_id":"52722dd35a2a24fa3133fa44"},{"state":"OH","medicaid_paid_prescriptions":175,"medicaid_reimbursed_usd":188016.55,"total_reimbursed_usd":196452.96,"packages":2,"covers":"fee_for_service_only","fact_id":"833cbfa1c8f250311f4d55a9"},{"state":"TX","medicaid_paid_prescriptions":227,"medicaid_reimbursed_usd":165852.27,"total_reimbursed_usd":169519.22,"packages":1,"covers":"fee_for_service_only","fact_id":"f8cb6d64bc3d94db94c47a35"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":27238,"medicaid_reimbursed_usd":26803121.59,"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":"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":"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."}