{"answer":{"query":"Tivicay","resolved_as":"applications","packages":4,"applications":["NDA204790"],"identity":{"application_numbers":["NDA204790"],"marketing_categories":["NDA"],"labelers":[{"text":"VIIV HEALTHCARE COMPANY","untrusted":true}],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2013-08-13","latest":"2026-01-16","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA204790","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":"002"},"latest_patent_expiry":"2030-06-08","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":12,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":0,"fact_id":"822207437cb648a6dce9cf7e"}],"label_history":{"events_total":23,"non_cmc_events":19,"counts_by_class":{"EFFICACY":8,"LABELING":11},"cmc_events":4,"recent_non_cmc_events":[{"application":"NDA204790","submission_no":34,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-08-25","documents":[{"type":"Letter","date":"2026-08-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/204790Orig1s034,213983Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-09-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204790s034lbl.pdf","untrusted":true}}],"fact_id":"ac4600090d7df2978eb0d0b8"},{"application":"NDA204790","submission_no":33,"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/2025/204790s033lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204790Orig1s033;213983Orig1s006ltr.pdf","untrusted":true}}],"fact_id":"a2b3a0a259b8e18b2e780c30"},{"application":"NDA204790","submission_no":31,"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/2024/204790s031,213983s004lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-04-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204790Orig1s031; 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213983Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"273c6ee236a67b308b392e6b"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"NOT_PROVIDED":3},"marketing_status_counts":{"Prescription":1,"Discontinued":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":"NDA204790","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TIVICAY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 50MG BASE","untrusted":true}},{"application":"NDA204790","product_no":"002","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"TIVICAY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","untrusted":true}},{"application":"NDA204790","product_no":"003","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"TIVICAY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","untrusted":true}}]},"recalls":{"recalls_total":2,"counts_by_class":{"Class III":2},"packages_of_these_applications":4,"most_recent":[{"recall_number":"D-0896-2022","classification":"Class III","status":"Terminated","report_date":"2022-06-01","recall_initiated":"2022-05-13","recalling_firm":{"text":"GlaxoSmithKline LLC","untrusted":true},"reason":{"text":"Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.","untrusted":true},"packages_named":1,"fact_id":"6441068cf387deb8e8803f27"},{"recall_number":"D-1185-2014","classification":"Class III","status":"Terminated","report_date":"2014-04-09","recall_initiated":"2014-02-11","recalling_firm":{"text":"Viiv Healthcare Company","untrusted":true},"reason":{"text":"Cross Contamination with Other Products: Product contains Promacta (eltrombopag).","untrusted":true},"packages_named":1,"fact_id":"d9f4d3e9087ca84fcb8b1c33"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":2,"next_package_termination_dates":["2027-05-31","2027-08-31"],"packages_with_future_termination_date":2,"termination_meaning":"manufacturer-reported last-lot expiry or withdrawal date of one package; other packages and generics can remain"},"spending":{"reported_under":{"generic":{"text":"Dolutegravir Sodium","untrusted":true},"brand":{"text":"Tivicay","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":656037861.54,"claims":311735,"beneficiaries":34771,"average_spending_per_claim_usd":2104.4729066,"fact_id":"d1ad0863b9c58b3d82025f02"},{"year":2021,"gross_spending_usd":648743459.17,"claims":297418,"beneficiaries":33419,"average_spending_per_claim_usd":2181.2515018,"fact_id":"a2721ac6c8e65d3ac94f65af"},{"year":2022,"gross_spending_usd":650460654.01,"claims":281776,"beneficiaries":31534,"average_spending_per_claim_usd":2308.4317117,"fact_id":"55ea97f8b5a6fdb3286efca1"},{"year":2023,"gross_spending_usd":657133269,"claims":266809,"beneficiaries":30088,"average_spending_per_claim_usd":2462.9351671,"fact_id":"31e29b932457746934baf3ec"},{"year":2024,"gross_spending_usd":629400835.91,"claims":255731,"beneficiaries":29205,"average_spending_per_claim_usd":2461.1831804,"fact_id":"9ec20226b763d5c0bc982ff7"}],"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":4538326.37,"all_states_medicaid_paid_prescriptions":1702,"top_states":[{"state":"PR","medicaid_paid_prescriptions":1702,"medicaid_reimbursed_usd":4538326.37,"total_reimbursed_usd":4600905.71,"packages":1,"covers":"all_record_types","fact_id":"61c6f87a71770426810b534e"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":49,"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":"10ba7e2c41c48cf3fa3a6981","field":"ndc.listing","entity":"ndc:49702022613"},{"fact_id":"e897508cde228e28fa3a9c66","field":"ndc.listing","entity":"ndc:49702022713"},{"fact_id":"9382590b2d85b6ca7b38b2d8","field":"ndc.listing","entity":"ndc:49702022813"},{"fact_id":"822207437cb648a6dce9cf7e","field":"drug.generic_entry_earliest","entity":"application:NDA204790"},{"fact_id":"2bc1b54962a34c50ad3d5358","field":"drug.patent","entity":"application:NDA204790"},{"fact_id":"ac4600090d7df2978eb0d0b8","field":"drug.label_event","entity":"application:NDA204790"},{"fact_id":"a2b3a0a259b8e18b2e780c30","field":"drug.label_event","entity":"application:NDA204790"},{"fact_id":"96ae77c3688a03b2e108c910","field":"drug.label_event","entity":"application:NDA204790"},{"fact_id":"cd5858524a9b6e80aba898e2","field":"drug.label_event","entity":"application:NDA204790"},{"fact_id":"273c6ee236a67b308b392e6b","field":"drug.label_event","entity":"application:NDA204790"},{"fact_id":"c3f1fdd455fdbc8a9863d402","field":"drug.marketing_status","entity":"application:NDA204790"},{"fact_id":"b5eb8b836c790c3df0bb574b","field":"drug.marketing_status","entity":"application:NDA204790"},{"fact_id":"6ad823d3cae7068d59f50604","field":"drug.marketing_status","entity":"application:NDA204790"},{"fact_id":"6441068cf387deb8e8803f27","field":"ndc.recall","entity":"ndc:49702022813"},{"fact_id":"d9f4d3e9087ca84fcb8b1c33","field":"ndc.recall","entity":"ndc:49702022813"},{"fact_id":"48005dc9ba0308e1c3c97e59","field":"ndc.product","entity":"ndc:49702022613"},{"fact_id":"affc85a47625977c3e7d68c6","field":"ndc.product","entity":"ndc:49702022713"},{"fact_id":"d1ad0863b9c58b3d82025f02","field":"drug.partd_spending","entity":"drug:dolutegravir-sodium|tivicay"},{"fact_id":"a2721ac6c8e65d3ac94f65af","field":"drug.partd_spending","entity":"drug:dolutegravir-sodium|tivicay"},{"fact_id":"55ea97f8b5a6fdb3286efca1","field":"drug.partd_spending","entity":"drug:dolutegravir-sodium|tivicay"},{"fact_id":"31e29b932457746934baf3ec","field":"drug.partd_spending","entity":"drug:dolutegravir-sodium|tivicay"},{"fact_id":"9ec20226b763d5c0bc982ff7","field":"drug.partd_spending","entity":"drug:dolutegravir-sodium|tivicay"},{"fact_id":"61c6f87a71770426810b534e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:49702022813: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":"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."}