{"answer":{"query":"Trintellix","resolved_as":"applications","packages":21,"applications":["NDA204447"],"identity":{"application_numbers":["NDA204447"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2013-10-02","latest":"2026-04-23","packages_with_a_start_date":21}},"generic_entry":[{"application":"NDA204447","date":"2032-09-21","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":"9278096*PED","productNo":"001"},"latest_patent_expiry":"2032-09-21","latest_exclusivity_expiry":"2027-02-23","dated_barriers":88,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":10,"exclusivities_listed":2,"fact_id":"46cc90ca9afc9eee36c98aed"}],"label_history":{"events_total":20,"non_cmc_events":16,"counts_by_class":{"EFFICACY":6,"LABELING":10},"cmc_events":4,"recent_non_cmc_events":[{"application":"NDA204447","submission_no":26,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-08-23","documents":[{"type":"Letter","date":"2023-08-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204447Orig1s026ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-08-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204447s026lbl.pdf","untrusted":true}}],"fact_id":"09be87661a5069506f7f2377"},{"application":"NDA204447","submission_no":27,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-08-18","documents":[{"type":"Label","date":"2023-08-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204447s027lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-08-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/ 204447Orig1s027ltr.pdf","untrusted":true}}],"fact_id":"5d96f8418d45f15912a2e835"},{"application":"NDA204447","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-09-20","documents":[{"type":"Letter","date":"2021-09-23","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204447Orig1s024ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-09-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s024lbl.pdf","untrusted":true}}],"fact_id":"dd64200b36884f83d4f46404"},{"application":"NDA204447","submission_no":22,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-01-22","documents":[{"type":"Letter","date":"2021-01-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204447Orig1s021, s022ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-01-28","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s021s022lbl.pdf","untrusted":true}}],"fact_id":"d46fe2b8820d7346724d1565"},{"application":"NDA204447","submission_no":21,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-01-22","documents":[{"type":"Letter","date":"2021-01-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204447Orig1s021, s022ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-01-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204447s021s022lbl.pdf","untrusted":true}}],"fact_id":"12f7b95e29414e84813e5073"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":4,"te_code_counts":{"NOT_PROVIDED":4},"marketing_status_counts":{"Prescription":3,"Discontinued":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":"NDA204447","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TRINTELLIX","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 20MG BASE","untrusted":true}},{"application":"NDA204447","product_no":"003","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"TRINTELLIX","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","untrusted":true}},{"application":"NDA204447","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TRINTELLIX","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 5MG BASE","untrusted":true}},{"application":"NDA204447","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TRINTELLIX","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 10MG BASE","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[],"manufacturer_offers":[{"program":"trintellix-savings-card","kind":"copay_card","price_figures":{"payAsLittleAs30or90DayPrescription":10,"savingsUpTo30Day":100,"savingsUpTo90Day":300,"maxTotalSavingsOverOneYear":1300},"conditions":{"text":"The page states only commercially insured patients aged 18 and older may use the card; it cannot be used by patients in government-funded programs or by cash patients; the program ends December 31, 2026, the final day to enroll and redeem.","untrusted":true},"limited_time":true,"expires_note":{"text":"The Savings Card program will end on December 31, 2026","untrusted":true},"stated_end_date":"2026-12-31","expired":false,"detail":{"text":"The Trintellix page states a Savings Card for commercially insured patients aged 18 and older: as little as $10 for a 30- or 90-day prescription, with savings of up to $100 per 30-day or $300 per 90-day prescription and maximum total savings of $1,300 over one year. The program will end on December 31, 2026.","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.trintellix.com/savings-and-support","proof_state":"verified","fact_id":"9c3eea3fffb3c85dac664f23"},{"program":"trintellix-direct-purchase","kind":"self_pay","price_figures":{"per30DayPrescription":299,"listPricePer30DayPrescription":540},"conditions":{"text":"The page states the $299 price is for a 30-day prescription and that eligibility requirements apply; it gives a list price of $540.00 for a 30-day prescription as of 01/01/2026.","untrusted":true},"limited_time":false,"expires_note":null,"stated_end_date":null,"expired":false,"detail":{"text":"The Trintellix page states a price without using insurance of $299 for a 30-day prescription and a list price of $540.00 for a 30-day prescription as of 01/01/2026. The page states eligibility requirements apply; no end date is stated for this price.","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.trintellix.com/savings-and-support","proof_state":"verified","fact_id":"dfbd5ed4aeadba6961446003"}],"note":"A program that lists a drug has not decided anything about any person: each program decides who qualifies, and a status other than open means it may not take new patients. Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Vortioxetine Hydrobromide","untrusted":true},"brand":{"text":"Trintellix","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":314974934.93,"claims":614838,"beneficiaries":97196,"average_spending_per_claim_usd":512.28931024,"fact_id":"955ff26918ebcbee5e6ba5fe"},{"year":2021,"gross_spending_usd":337760606.36,"claims":602952,"beneficiaries":98289,"average_spending_per_claim_usd":560.17826686,"fact_id":"7d14cd89e3a5487d06066fb5"},{"year":2022,"gross_spending_usd":366780643.48,"claims":606443,"beneficiaries":97420,"average_spending_per_claim_usd":604.80645911,"fact_id":"8fb4f3e1a51c3f150dc32e58"},{"year":2023,"gross_spending_usd":389714301.5,"claims":602887,"beneficiaries":98771,"average_spending_per_claim_usd":646.4135095,"fact_id":"da1b81b3fab2bf4a85dbdf67"},{"year":2024,"gross_spending_usd":392486138.2,"claims":610008,"beneficiaries":100706,"average_spending_per_claim_usd":643.41146051,"fact_id":"870b9180ebbc3bfa63adc581"}],"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":2,"all_states_medicaid_reimbursed_usd":110371.13,"all_states_medicaid_paid_prescriptions":192,"top_states":[{"state":"VT","medicaid_paid_prescriptions":104,"medicaid_reimbursed_usd":62165.87,"total_reimbursed_usd":62165.87,"packages":1,"covers":"all_record_types","fact_id":"b853cc9719a8b89c9dc1df79"},{"state":"SD","medicaid_paid_prescriptions":88,"medicaid_reimbursed_usd":48205.26,"total_reimbursed_usd":48224.01,"packages":1,"covers":"all_record_types","fact_id":"44186da64c5981466f7e9771"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":0,"older_year_facts_not_used":152,"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":"7c589e455e5a94795c0c7c93","field":"ndc.listing","entity":"ndc:55154025608"},{"fact_id":"7f67dc69a7c17b8479f8d712","field":"ndc.listing","entity":"ndc:55154025708"},{"fact_id":"1bab96810cab6f2ef5a1d5a4","field":"ndc.listing","entity":"ndc:64764072007"},{"fact_id":"46cc90ca9afc9eee36c98aed","field":"drug.generic_entry_earliest","entity":"application:NDA204447"},{"fact_id":"325dfc67032f4190a40e0730","field":"drug.patent","entity":"application:NDA204447"},{"fact_id":"cd0a29459e4633ed158bbdd3","field":"drug.exclusivity","entity":"application:NDA204447"},{"fact_id":"09be87661a5069506f7f2377","field":"drug.label_event","entity":"application:NDA204447"},{"fact_id":"5d96f8418d45f15912a2e835","field":"drug.label_event","entity":"application:NDA204447"},{"fact_id":"dd64200b36884f83d4f46404","field":"drug.label_event","entity":"application:NDA204447"},{"fact_id":"d46fe2b8820d7346724d1565","field":"drug.label_event","entity":"application:NDA204447"},{"fact_id":"12f7b95e29414e84813e5073","field":"drug.label_event","entity":"application:NDA204447"},{"fact_id":"e1c6744aa94db5080e6dd363","field":"drug.marketing_status","entity":"application:NDA204447"},{"fact_id":"b45aec35c1184a0a7736f405","field":"drug.marketing_status","entity":"application:NDA204447"},{"fact_id":"afe5d505f96cf5dd544c4d79","field":"drug.marketing_status","entity":"application:NDA204447"},{"fact_id":"49a7e34ff50257296e73ec13","field":"drug.marketing_status","entity":"application:NDA204447"},{"fact_id":"dfbd5ed4aeadba6961446003","field":"program.offer","entity":"program:trintellix-direct-purchase"},{"fact_id":"9c3eea3fffb3c85dac664f23","field":"program.offer","entity":"program:trintellix-savings-card"},{"fact_id":"955ff26918ebcbee5e6ba5fe","field":"drug.partd_spending","entity":"drug:vortioxetine-hydrobromide|trintellix"},{"fact_id":"7d14cd89e3a5487d06066fb5","field":"drug.partd_spending","entity":"drug:vortioxetine-hydrobromide|trintellix"},{"fact_id":"8fb4f3e1a51c3f150dc32e58","field":"drug.partd_spending","entity":"drug:vortioxetine-hydrobromide|trintellix"},{"fact_id":"da1b81b3fab2bf4a85dbdf67","field":"drug.partd_spending","entity":"drug:vortioxetine-hydrobromide|trintellix"},{"fact_id":"870b9180ebbc3bfa63adc581","field":"drug.partd_spending","entity":"drug:vortioxetine-hydrobromide|trintellix"},{"fact_id":"b853cc9719a8b89c9dc1df79","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764072030:VT"},{"fact_id":"44186da64c5981466f7e9771","field":"ndc.medicaid_state_utilization","entity":"ndc_state:64764072030: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":"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":"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."}