{"answer":{"query":"Triumeq","resolved_as":"applications","packages":1,"applications":["NDA205551"],"identity":{"application_numbers":["NDA205551"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2014-08-22","latest":"2014-08-22","packages_with_a_start_date":1}},"generic_entry":[{"application":"NDA205551","date":"2030-06-08","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":"9242986*PED","productNo":"001"},"latest_patent_expiry":"2030-06-08","latest_exclusivity_expiry":"2026-12-15","dated_barriers":6,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":2,"fact_id":"6e0ed9ca1e77bfab06d88087"}],"label_history":{"events_total":20,"non_cmc_events":18,"counts_by_class":{"LABELING":13,"EFFICACY":5},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA205551","submission_no":34,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-10-28","documents":[{"type":"Label","date":"2025-10-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/205551s034lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/205551Orig1s034;215413Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"14c3c2bbd515c685ab1f5bac"},{"application":"NDA205551","submission_no":32,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-04-18","documents":[{"type":"Label","date":"2024-04-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205551s032,215413s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-04-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205551Orig1s032; 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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":"NDA205551","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TRIUMEQ","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 600MG BASE;EQ 50MG BASE;300MG","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":1,"most_recent":[{"recall_number":"D-0486-2021","classification":"Class II","status":"Terminated","report_date":"2021-06-02","recall_initiated":"2021-03-15","recalling_firm":{"text":"Cardinal Health Inc.","untrusted":true},"reason":{"text":"CGMP Deviations: Intermittent exposure to temperature excursion during storage.","untrusted":true},"packages_named":1,"fact_id":"29f260f45792ea338cbc2ad3"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Abacavir/Dolutegravir/Lamivudi","untrusted":true},"brand":{"text":"Triumeq","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":738986222.11,"claims":221077,"beneficiaries":24217,"average_spending_per_claim_usd":3342.6644206,"fact_id":"79a60b5e3b6e65a36327a132"},{"year":2021,"gross_spending_usd":697732871.52,"claims":201991,"beneficiaries":22392,"average_spending_per_claim_usd":3454.2770298,"fact_id":"96d7436789680276f535fddf"},{"year":2022,"gross_spending_usd":669969234.11,"claims":183179,"beneficiaries":20267,"average_spending_per_claim_usd":3657.456554,"fact_id":"01acf3367463892ce2c34fdc"},{"year":2023,"gross_spending_usd":631607443.23,"claims":160843,"beneficiaries":18047,"average_spending_per_claim_usd":3926.8568929,"fact_id":"ca039d0e61a9e3a166bc6707"},{"year":2024,"gross_spending_usd":565891468.38,"claims":143167,"beneficiaries":16151,"average_spending_per_claim_usd":3952.6669441,"fact_id":"131e0bf9327cd73b50b849cd"}],"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":1,"all_states_medicaid_reimbursed_usd":4003734.59,"all_states_medicaid_paid_prescriptions":1043,"top_states":[{"state":"PR","medicaid_paid_prescriptions":1043,"medicaid_reimbursed_usd":4003734.59,"total_reimbursed_usd":4003734.59,"packages":1,"covers":"all_record_types","fact_id":"c5e233f1a81e508f79db4f6f"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":48,"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":"572d1670ff84e5b5198245f7","field":"ndc.listing","entity":"ndc:49702023113"},{"fact_id":"6e0ed9ca1e77bfab06d88087","field":"drug.generic_entry_earliest","entity":"application:NDA205551"},{"fact_id":"9f18c8a75a5407f552feef6f","field":"drug.patent","entity":"application:NDA205551"},{"fact_id":"d0a08b5dae5b1ef846d0f102","field":"drug.exclusivity","entity":"application:NDA205551"},{"fact_id":"14c3c2bbd515c685ab1f5bac","field":"drug.label_event","entity":"application:NDA205551"},{"fact_id":"c698413416237e71b8997f0a","field":"drug.label_event","entity":"application:NDA205551"},{"fact_id":"209ad9699c886c3b6c6b71f9","field":"drug.label_event","entity":"application:NDA205551"},{"fact_id":"2a813a02ee91eecfca931500","field":"drug.label_event","entity":"application:NDA205551"},{"fact_id":"9ac37374e6e189274991796a","field":"drug.label_event","entity":"application:NDA205551"},{"fact_id":"114642535ef139630b11ef46","field":"drug.marketing_status","entity":"application:NDA205551"},{"fact_id":"29f260f45792ea338cbc2ad3","field":"ndc.recall","entity":"ndc:49702023113"},{"fact_id":"79a60b5e3b6e65a36327a132","field":"drug.partd_spending","entity":"drug:abacavir-dolutegravir-lamivudi|triumeq"},{"fact_id":"96d7436789680276f535fddf","field":"drug.partd_spending","entity":"drug:abacavir-dolutegravir-lamivudi|triumeq"},{"fact_id":"01acf3367463892ce2c34fdc","field":"drug.partd_spending","entity":"drug:abacavir-dolutegravir-lamivudi|triumeq"},{"fact_id":"ca039d0e61a9e3a166bc6707","field":"drug.partd_spending","entity":"drug:abacavir-dolutegravir-lamivudi|triumeq"},{"fact_id":"131e0bf9327cd73b50b849cd","field":"drug.partd_spending","entity":"drug:abacavir-dolutegravir-lamivudi|triumeq"},{"fact_id":"c5e233f1a81e508f79db4f6f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:49702023113:PR"}],"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":"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."}