{"answer":{"query":"Wakix","resolved_as":"applications","packages":2,"applications":["NDA211150"],"identity":{"application_numbers":["NDA211150"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2019-08-14","latest":"2019-08-14","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA211150","date":"2033-02-13","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":"exclusivity","ref":"ODE-519","productNo":"001"},"latest_patent_expiry":"2030-03-07","latest_exclusivity_expiry":"2033-02-13","dated_barriers":16,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":5,"fact_id":"d3df11a461b85afcfa994694"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"EFFICACY":2,"LABELING":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA211150","submission_no":6,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-02-13","documents":[{"type":"Letter","date":"2026-02-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/211150Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-02-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211150s006lbl.pdf","untrusted":true}}],"fact_id":"bf65d87f3fa5a032d4bdb8f5"},{"application":"NDA211150","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-05-23","documents":[{"type":"Letter","date":"2025-05-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211150Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-06-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211150s007lbl.pdf","untrusted":true}}],"fact_id":"150698e0f1e9ed7a4f38e22d"},{"application":"NDA211150","submission_no":5,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-06-21","documents":[{"type":"Label","date":"2024-06-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/211150s005s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-09-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/211150Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"56412231e063d370cdd0b48c"},{"application":"NDA211150","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-12-22","documents":[{"type":"Letter","date":"2022-12-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/211150Orig1s003ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-12-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/211150s003lbl.pdf","untrusted":true}}],"fact_id":"bb31a127589593dc0ed6bdb1"}],"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":"NDA211150","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"WAKIX","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 17.8MG BASE","untrusted":true}},{"application":"NDA211150","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"WAKIX","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 4.45MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Pitolisant HCl","untrusted":true},"brand":{"text":"Wakix","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":31542408.29,"claims":3671,"beneficiaries":657,"average_spending_per_claim_usd":8592.3204277,"fact_id":"54dee596e53acd5f21683733"},{"year":2021,"gross_spending_usd":55827154.21,"claims":5502,"beneficiaries":825,"average_spending_per_claim_usd":10146.701965,"fact_id":"686794fcb723e58bd2ca2684"},{"year":2022,"gross_spending_usd":65551787.43,"claims":6217,"beneficiaries":940,"average_spending_per_claim_usd":10543.958088,"fact_id":"6b0787343db2216ece377fbc"},{"year":2023,"gross_spending_usd":101374312.73,"claims":8703,"beneficiaries":1235,"average_spending_per_claim_usd":11648.203232,"fact_id":"cd3b25db156cd4853f49c666"},{"year":2024,"gross_spending_usd":132456457.85,"claims":10596,"beneficiaries":1402,"average_spending_per_claim_usd":12500.609461,"fact_id":"500165ee5efc77bdf57f8d25"}],"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":7,"all_states_medicaid_reimbursed_usd":7035588.32,"all_states_medicaid_paid_prescriptions":571,"top_states":[{"state":"MN","medicaid_paid_prescriptions":128,"medicaid_reimbursed_usd":1688620.18,"total_reimbursed_usd":1688620.18,"packages":1,"covers":"fee_for_service_only","fact_id":"936faf0911dfb50d12460cb0"},{"state":"SC","medicaid_paid_prescriptions":114,"medicaid_reimbursed_usd":1532009.5,"total_reimbursed_usd":1532009.5,"packages":1,"covers":"fee_for_service_only","fact_id":"6bd774bbf41ff3a0dc2b060c"},{"state":"UT","medicaid_paid_prescriptions":73,"medicaid_reimbursed_usd":1089562.03,"total_reimbursed_usd":1089562.03,"packages":1,"covers":"fee_for_service_only","fact_id":"2f382dab2d49842a6e9b9980"},{"state":"ME","medicaid_paid_prescriptions":67,"medicaid_reimbursed_usd":928845.37,"total_reimbursed_usd":928845.37,"packages":1,"covers":"all_record_types","fact_id":"42dccaca133fe12580dfb4fc"},{"state":"WI","medicaid_paid_prescriptions":71,"medicaid_reimbursed_usd":892936.62,"total_reimbursed_usd":893014.62,"packages":1,"covers":"all_record_types","fact_id":"c1a62c4cc87734e6e8ab1ab2"},{"state":"AR","medicaid_paid_prescriptions":56,"medicaid_reimbursed_usd":603243.61,"total_reimbursed_usd":603243.61,"packages":1,"covers":"fee_for_service_only","fact_id":"926bd54be427140ca395f215"},{"state":"IL","medicaid_paid_prescriptions":62,"medicaid_reimbursed_usd":300371.01,"total_reimbursed_usd":300371.01,"packages":1,"covers":"all_record_types","fact_id":"699b62ba8307db8a922dc20a"}],"unlabelled_state_code_xx":null,"built_from_facts":7,"facts_fee_for_service_only":4,"older_year_facts_not_used":38,"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":"5654bf2a544678e8ebc3a10d","field":"ndc.listing","entity":"ndc:72028004503"},{"fact_id":"e00b0f998a09085e02b57cec","field":"ndc.listing","entity":"ndc:72028017803"},{"fact_id":"d3df11a461b85afcfa994694","field":"drug.generic_entry_earliest","entity":"application:NDA211150"},{"fact_id":"d7a9251f7b46750d34cb1083","field":"drug.patent","entity":"application:NDA211150"},{"fact_id":"aad2e89c0daea03b76ab6217","field":"drug.exclusivity","entity":"application:NDA211150"},{"fact_id":"bf65d87f3fa5a032d4bdb8f5","field":"drug.label_event","entity":"application:NDA211150"},{"fact_id":"150698e0f1e9ed7a4f38e22d","field":"drug.label_event","entity":"application:NDA211150"},{"fact_id":"56412231e063d370cdd0b48c","field":"drug.label_event","entity":"application:NDA211150"},{"fact_id":"bb31a127589593dc0ed6bdb1","field":"drug.label_event","entity":"application:NDA211150"},{"fact_id":"c206f18b0ec54027886cf328","field":"drug.te_code","entity":"application:NDA211150"},{"fact_id":"9c23687f8782acd82238bfca","field":"drug.marketing_status","entity":"application:NDA211150"},{"fact_id":"b3deeb20386d66989c71bcb2","field":"drug.te_code","entity":"application:NDA211150"},{"fact_id":"746d9771707177b18fd49694","field":"drug.marketing_status","entity":"application:NDA211150"},{"fact_id":"54dee596e53acd5f21683733","field":"drug.partd_spending","entity":"drug:pitolisant-hcl|wakix"},{"fact_id":"686794fcb723e58bd2ca2684","field":"drug.partd_spending","entity":"drug:pitolisant-hcl|wakix"},{"fact_id":"6b0787343db2216ece377fbc","field":"drug.partd_spending","entity":"drug:pitolisant-hcl|wakix"},{"fact_id":"cd3b25db156cd4853f49c666","field":"drug.partd_spending","entity":"drug:pitolisant-hcl|wakix"},{"fact_id":"500165ee5efc77bdf57f8d25","field":"drug.partd_spending","entity":"drug:pitolisant-hcl|wakix"},{"fact_id":"936faf0911dfb50d12460cb0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72028017803:MN"},{"fact_id":"6bd774bbf41ff3a0dc2b060c","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72028017803:SC"},{"fact_id":"2f382dab2d49842a6e9b9980","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72028017803:UT"},{"fact_id":"42dccaca133fe12580dfb4fc","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72028017803:ME"},{"fact_id":"c1a62c4cc87734e6e8ab1ab2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72028017803:WI"},{"fact_id":"926bd54be427140ca395f215","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72028017803:AR"},{"fact_id":"699b62ba8307db8a922dc20a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:72028004503:IL"}],"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":"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."}