{"answer":{"query":"Odefsey","resolved_as":"applications","packages":1,"applications":["NDA208351"],"identity":{"application_numbers":["NDA208351"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2016-03-01","latest":"2016-03-01","packages_with_a_start_date":1}},"generic_entry":[{"application":"NDA208351","date":"2033-02-15","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":"8754065*PED","productNo":"001"},"latest_patent_expiry":"2033-02-15","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":4,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":0,"fact_id":"de215109c5bf05025c652654"}],"label_history":{"events_total":9,"non_cmc_events":9,"counts_by_class":{"EFFICACY":6,"LABELING":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA208351","submission_no":15,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-02-19","documents":[{"type":"Label","date":"2025-02-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208351s014s015lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208351Orig1s014, s015ltr.pdf","untrusted":true}}],"fact_id":"84835364fc8ace5f45448c80"},{"application":"NDA208351","submission_no":14,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-02-19","documents":[{"type":"Label","date":"2025-02-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208351s014s015lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208351Orig1s014, s015ltr.pdf","untrusted":true}}],"fact_id":"269e3ed6584984b37cc9ee76"},{"application":"NDA208351","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-09-10","documents":[{"type":"Label","date":"2021-09-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208351s013lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-09-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208351Orig1s013ltr.pdf","untrusted":true}}],"fact_id":"4dc815500cfb5ee6e19a75d2"},{"application":"NDA208351","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-03-04","documents":[{"type":"Letter","date":"2021-03-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208351Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-03-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208351s011lbl.pdf","untrusted":true}}],"fact_id":"52febd20f4d9bd948e3ed8e2"},{"application":"NDA208351","submission_no":10,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-12-03","documents":[{"type":"Letter","date":"2019-12-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208351Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2019-12-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208351s010lbl.pdf","untrusted":true}}],"fact_id":"9bb33a4b3d4e417904b5ad7a"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"AB":1},"marketing_status_counts":{"Prescription":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":"NDA208351","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"ODEFSEY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"200MG;EQ 25MG BASE;EQ 25MG BASE","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[],"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":"Emtricitab/Rilpiviri/Tenof Ala","untrusted":true},"brand":{"text":"Odefsey","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":358188116.95,"claims":110160,"beneficiaries":11641,"average_spending_per_claim_usd":3251.5261161,"fact_id":"cd2691453e3304e5f401ae8d"},{"year":2021,"gross_spending_usd":361085876.81,"claims":106671,"beneficiaries":11342,"average_spending_per_claim_usd":3385.0425777,"fact_id":"5d9a63a02dc4f08266c3cf30"},{"year":2022,"gross_spending_usd":371681940,"claims":102932,"beneficiaries":10906,"average_spending_per_claim_usd":3610.9464501,"fact_id":"a6e8a831a051953f8bbab253"},{"year":2023,"gross_spending_usd":383667795.21,"claims":98932,"beneficiaries":10542,"average_spending_per_claim_usd":3878.0960176,"fact_id":"ef408a0783ab1af674da8f0d"},{"year":2024,"gross_spending_usd":375477600.43,"claims":97021,"beneficiaries":10329,"average_spending_per_claim_usd":3870.065248,"fact_id":"8dadf7c610fb27153759e532"}],"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":5490383.33,"all_states_medicaid_paid_prescriptions":1465,"top_states":[{"state":"PR","medicaid_paid_prescriptions":1465,"medicaid_reimbursed_usd":5490383.33,"total_reimbursed_usd":5539741.73,"packages":1,"covers":"all_record_types","fact_id":"0e3587386975ea2815bd20b6"}],"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":"946a7d479a2b3c10f3f12a7e","field":"ndc.listing","entity":"ndc:61958210101"},{"fact_id":"de215109c5bf05025c652654","field":"drug.generic_entry_earliest","entity":"application:NDA208351"},{"fact_id":"95c5cfe1bd514bf6853de3ea","field":"drug.patent","entity":"application:NDA208351"},{"fact_id":"84835364fc8ace5f45448c80","field":"drug.label_event","entity":"application:NDA208351"},{"fact_id":"269e3ed6584984b37cc9ee76","field":"drug.label_event","entity":"application:NDA208351"},{"fact_id":"4dc815500cfb5ee6e19a75d2","field":"drug.label_event","entity":"application:NDA208351"},{"fact_id":"52febd20f4d9bd948e3ed8e2","field":"drug.label_event","entity":"application:NDA208351"},{"fact_id":"9bb33a4b3d4e417904b5ad7a","field":"drug.label_event","entity":"application:NDA208351"},{"fact_id":"e5aaa80edbdf85c9274f44a4","field":"drug.te_code","entity":"application:NDA208351"},{"fact_id":"428292317abfd58929565f24","field":"drug.marketing_status","entity":"application:NDA208351"},{"fact_id":"44c0ef2415d99be7c7cada54","field":"program.offer","entity":"program:gilead-copay-savings-program"},{"fact_id":"cd2691453e3304e5f401ae8d","field":"drug.partd_spending","entity":"drug:emtricitab-rilpiviri-tenof-ala|odefsey"},{"fact_id":"5d9a63a02dc4f08266c3cf30","field":"drug.partd_spending","entity":"drug:emtricitab-rilpiviri-tenof-ala|odefsey"},{"fact_id":"a6e8a831a051953f8bbab253","field":"drug.partd_spending","entity":"drug:emtricitab-rilpiviri-tenof-ala|odefsey"},{"fact_id":"ef408a0783ab1af674da8f0d","field":"drug.partd_spending","entity":"drug:emtricitab-rilpiviri-tenof-ala|odefsey"},{"fact_id":"8dadf7c610fb27153759e532","field":"drug.partd_spending","entity":"drug:emtricitab-rilpiviri-tenof-ala|odefsey"},{"fact_id":"0e3587386975ea2815bd20b6","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61958210101: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":"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."}