{"answer":{"query":"biktarvy","resolved_as":"name","packages":4,"applications":["NDA210251"],"identity":{"application_numbers":["NDA210251"],"marketing_categories":["NDA"],"labelers":[{"text":"GILEAD SCIENCES, INC.","untrusted":true}],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2018-02-07","latest":"2024-10-08","packages_with_a_start_date":4}},"price":{"median_negotiated_over_nadac":null,"packages_compared":0,"packages_listed":4,"negotiated_price_ends":null,"rows":[{"ndc":"61958250101","name":{"text":"Biktarvy","untrusted":true},"class":"B","nadac_per_unit":136.75307,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"61958250103","name":{"text":"Biktarvy Blister Pack","untrusted":true},"class":"B","nadac_per_unit":136.75307,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"61958250501","name":{"text":"BIKTARVY 30/120/15 mg TABLETS","untrusted":true},"class":"B","nadac_per_unit":136.62682,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"61958250601","name":{"text":"BIKTARVY 30 mg/120 mg/15 mg LD tablets","untrusted":true},"class":"B","nadac_per_unit":136.62682,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null}],"negotiated_scheduled":null},"generic_entry":[{"application":"NDA210251","date":"2036-11-08","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":"10548846","productNo":"001"},"latest_patent_expiry":"2036-11-08","latest_exclusivity_expiry":"2032-07-30","dated_barriers":29,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":9,"exclusivities_listed":6,"fact_id":"8dea41d8d867fcf2f770da70"}],"label_history":{"events_total":15,"non_cmc_events":13,"counts_by_class":{"EFFICACY":8,"LABELING":5},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA210251","submission_no":23,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-07-30","documents":[{"type":"Label","date":"2025-07-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210251s023lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-08-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210251Orig1s023ltr.pdf","untrusted":true}}],"fact_id":"1ab2217be71881b4d2c24e1f"},{"application":"NDA210251","submission_no":19,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-04-24","documents":[{"type":"Letter","date":"2024-04-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210251Orig1s019ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-04-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251s019lbl.pdf","untrusted":true}}],"fact_id":"40bea056ea63662ad8ad9e6b"},{"application":"NDA210251","submission_no":18,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-02-23","documents":[{"type":"Label","date":"2024-02-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210251s018lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-02-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210251Orig1s018ltr.pdf","untrusted":true}}],"fact_id":"306c7f57e0a117247da96797"},{"application":"NDA210251","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-05-01","documents":[{"type":"Label","date":"2023-05-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/210251Orig1s017lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-05-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/210251Orig1s017ltr.pdf","untrusted":true}}],"fact_id":"b023700d093e51061c30c899"},{"application":"NDA210251","submission_no":15,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-10-14","documents":[{"type":"Letter","date":"2022-10-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210251Orig1s015ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-10-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210251s015lbl.pdf","untrusted":true}}],"fact_id":"de995b83f62348be4f805d4f"}],"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":{"NOT_PROVIDED":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":"NDA210251","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"BIKTARVY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 50MG BASE;200MG;EQ 25MG BASE","untrusted":true}},{"application":"NDA210251","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"BIKTARVY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"EQ 30MG BASE;120MG;EQ 15MG BASE","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Gilead Advancing Access","untrusted":true},"type":"manufacturer","url":"https://www.gileadadvancingaccess.com/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"Ryan White HIV/AIDS Program","untrusted":true},"type":"federal","url":"https://ryanwhite.hrsa.gov/","status":null,"needs_status_check":false,"has_offer":false},{"name":{"text":"AIDS Drug Assistance Programs (ADAP)","untrusted":true},"type":"federal","url":"https://hab.hrsa.gov/about-ryan-white-hivaids-program/part-b-aids-drug-assistance-program","status":null,"needs_status_check":false,"has_offer":false}],"manufacturer_offers":[{"program":"gilead-copay-savings-program","kind":"copay_card","price_figures":{"perCalendarYear":{"BIXLENVO":8500,"YEZTUGO":8000,"SUNLENCA":9600,"BIKTARVY, DESCOVY, GENVOYA, TRUVADA":7200,"ODEFSEY, STRIBILD, COMPLERA":6000,"EMTRIVA":3600,"TYBOST":600},"monthlyMax":{"EMTRIVA":300,"TYBOST":50},"injectionAdministrationPerVisit":{"YEZTUGO":100,"SUNLENCA":100}},"conditions":{"text":"The page states the program is for commercially insured patients with a valid prescription; the amounts are cost-sharing assistance per calendar year; the card auto-renews January 1 each year; patients who begin receiving government program benefits can no longer use it.","untrusted":true},"limited_time":false,"expires_note":null,"stated_end_date":null,"expired":false,"detail":{"text":"The Gilead Advancing Access page lists co-pay savings of up to $8,500 per calendar year (Bixlenvo), $8,000 (Yeztugo), $9,600 (Sunlenca), $7,200 (Biktarvy, Descovy, Genvoya, Truvada), $6,000 (Odefsey, Stribild, Complera), $3,600 with a $300 monthly maximum (Emtriva) and $600 with a $50 monthly maximum (Tybost). Yeztugo and Sunlenca amounts include up to $100 per visit for injection administration. The card auto-renews January 1 each year.","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.gileadadvancingaccess.com/patient","proof_state":"verified","fact_id":"44c0ef2415d99be7c7cada54"}],"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":"Bictegrav/Emtricit/Tenofov Ala","untrusted":true},"brand":{"text":"Biktarvy","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":1775846507.3,"claims":500405,"beneficiaries":55805,"average_spending_per_claim_usd":3548.8184716,"fact_id":"4b84439165d9dbb6b4df440b"},{"year":2021,"gross_spending_usd":2198270148.7,"claims":594197,"beneficiaries":66319,"average_spending_per_claim_usd":3699.5645362,"fact_id":"87a8e6366a2d21670cabd4af"},{"year":2022,"gross_spending_usd":2703581194.5,"claims":686161,"beneficiaries":75791,"average_spending_per_claim_usd":3940.1557281,"fact_id":"0d19c5def25895d6b39ffdbb"},{"year":2023,"gross_spending_usd":3152256268.6,"claims":756486,"beneficiaries":83843,"average_spending_per_claim_usd":4166.972381,"fact_id":"103e1963888fe92a798af808"},{"year":2024,"gross_spending_usd":3456061331.1,"claims":840772,"beneficiaries":92246,"average_spending_per_claim_usd":4110.580908,"fact_id":"d984ff02fdcd0bad3be102c7"}],"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":4,"all_states_medicaid_reimbursed_usd":32755851,"all_states_medicaid_paid_prescriptions":7924,"top_states":[{"state":"PR","medicaid_paid_prescriptions":7733,"medicaid_reimbursed_usd":31950868.89,"total_reimbursed_usd":32060374.78,"packages":2,"covers":"all_record_types","fact_id":"12d96ab81bc0e4f1a7d8eb8f"},{"state":"NH","medicaid_paid_prescriptions":84,"medicaid_reimbursed_usd":337423.29,"total_reimbursed_usd":337423.29,"packages":1,"covers":"all_record_types","fact_id":"298b1960911701b3c72ddaed"},{"state":"MS","medicaid_paid_prescriptions":55,"medicaid_reimbursed_usd":295160.79,"total_reimbursed_usd":299054.39,"packages":1,"covers":"fee_for_service_only","fact_id":"733bb4d9b66372d22c52973e"},{"state":"KY","medicaid_paid_prescriptions":52,"medicaid_reimbursed_usd":172398.03,"total_reimbursed_usd":172398.03,"packages":1,"covers":"all_record_types","fact_id":"0541ec74e1f78c675bf93884"}],"unlabelled_state_code_xx":null,"built_from_facts":5,"facts_fee_for_service_only":1,"older_year_facts_not_used":104,"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":"1a0584a997d6aa874ae0894a","field":"ndc.listing","entity":"ndc:61958250101"},{"fact_id":"b240f38df9780394c242f9ca","field":"ndc.listing","entity":"ndc:61958250103"},{"fact_id":"c72d14d2accfb56399f3b35c","field":"ndc.listing","entity":"ndc:61958250501"},{"fact_id":"8dea41d8d867fcf2f770da70","field":"drug.generic_entry_earliest","entity":"application:NDA210251"},{"fact_id":"c08351aa92cdd4741a295856","field":"drug.patent","entity":"application:NDA210251"},{"fact_id":"7039f43e59412e6eba92699e","field":"drug.exclusivity","entity":"application:NDA210251"},{"fact_id":"1ab2217be71881b4d2c24e1f","field":"drug.label_event","entity":"application:NDA210251"},{"fact_id":"40bea056ea63662ad8ad9e6b","field":"drug.label_event","entity":"application:NDA210251"},{"fact_id":"306c7f57e0a117247da96797","field":"drug.label_event","entity":"application:NDA210251"},{"fact_id":"b023700d093e51061c30c899","field":"drug.label_event","entity":"application:NDA210251"},{"fact_id":"de995b83f62348be4f805d4f","field":"drug.label_event","entity":"application:NDA210251"},{"fact_id":"c2e760252fd2356034c76d04","field":"drug.marketing_status","entity":"application:NDA210251"},{"fact_id":"1b4f7e1c3e376b15486638b6","field":"drug.marketing_status","entity":"application:NDA210251"},{"fact_id":"44c0ef2415d99be7c7cada54","field":"program.offer","entity":"program:gilead-copay-savings-program"},{"fact_id":"4b84439165d9dbb6b4df440b","field":"drug.partd_spending","entity":"drug:bictegrav-emtricit-tenofov-ala|biktarvy"},{"fact_id":"87a8e6366a2d21670cabd4af","field":"drug.partd_spending","entity":"drug:bictegrav-emtricit-tenofov-ala|biktarvy"},{"fact_id":"0d19c5def25895d6b39ffdbb","field":"drug.partd_spending","entity":"drug:bictegrav-emtricit-tenofov-ala|biktarvy"},{"fact_id":"103e1963888fe92a798af808","field":"drug.partd_spending","entity":"drug:bictegrav-emtricit-tenofov-ala|biktarvy"},{"fact_id":"d984ff02fdcd0bad3be102c7","field":"drug.partd_spending","entity":"drug:bictegrav-emtricit-tenofov-ala|biktarvy"},{"fact_id":"12d96ab81bc0e4f1a7d8eb8f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61958250101:PR"},{"fact_id":"298b1960911701b3c72ddaed","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61958250103:NH"},{"fact_id":"733bb4d9b66372d22c52973e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61958250103:MS"},{"fact_id":"0541ec74e1f78c675bf93884","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61958250501:KY"}],"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.ratio","reason":"no package has both a brand-class NADAC price and a negotiated price in force"},{"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":"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."}