{"answer":{"query":"Descovy","resolved_as":"applications","packages":3,"applications":["NDA208215"],"identity":{"application_numbers":["NDA208215"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2016-04-04","latest":"2022-01-07","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA208215","date":"2036-06-29","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":"12629338","productNo":"001"},"latest_patent_expiry":"2036-06-29","latest_exclusivity_expiry":"2032-06-20","dated_barriers":18,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":6,"exclusivities_listed":3,"fact_id":"73d878c60ae98d5d91d90f0a"}],"label_history":{"events_total":10,"non_cmc_events":9,"counts_by_class":{"EFFICACY":6,"LABELING":3},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA208215","submission_no":25,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-06-20","documents":[{"type":"Label","date":"2025-06-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208215s023s025lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-06-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208215Orig1s23s25ltr.pdf","untrusted":true}}],"fact_id":"37d49691c5c199e5dcce7c3b"},{"application":"NDA208215","submission_no":23,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-06-20","documents":[{"type":"Label","date":"2025-06-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208215s023s025lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-06-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208215Orig1s23s25ltr.pdf","untrusted":true}}],"fact_id":"fd6f18bc21ea5b31f6c0cced"},{"application":"NDA208215","submission_no":20,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-01-07","documents":[{"type":"Letter","date":"2022-01-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208215Orig1s020ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-01-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s020lbl.pdf","untrusted":true}}],"fact_id":"797b81fd9d36e118b6282012"},{"application":"NDA208215","submission_no":19,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-09-15","documents":[{"type":"Letter","date":"2021-09-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/0208215Orig1s019ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-09-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s019lbl.pdf","untrusted":true}}],"fact_id":"3da00404f0d7cd1debe62d53"},{"application":"NDA208215","submission_no":17,"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/2021/208215Orig1s017ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208215s017lbl.pdf","untrusted":true}}],"fact_id":"56781f744a3dec71816d1176"}],"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":{"AB":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":"NDA208215","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"DESCOVY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"200MG;EQ 25MG BASE","untrusted":true}},{"application":"NDA208215","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"DESCOVY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"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":"Emtricitabine/Tenofov Alafenam","untrusted":true},"brand":{"text":"Descovy","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":557919939.77,"claims":278040,"beneficiaries":32107,"average_spending_per_claim_usd":2006.6175362,"fact_id":"9181f6d60c9501393a37d8a3"},{"year":2021,"gross_spending_usd":559524804.15,"claims":269526,"beneficiaries":31242,"average_spending_per_claim_usd":2075.95855,"fact_id":"725b2b842b60157f906949bb"},{"year":2022,"gross_spending_usd":574036753.46,"claims":259325,"beneficiaries":30228,"average_spending_per_claim_usd":2213.5804626,"fact_id":"afbdc1cbf686b84a4ce726c3"},{"year":2023,"gross_spending_usd":589840789.31,"claims":249185,"beneficiaries":29514,"average_spending_per_claim_usd":2367.0798375,"fact_id":"190147bd58d6ebcb5638dcfa"},{"year":2024,"gross_spending_usd":544696049.72,"claims":238782,"beneficiaries":30179,"average_spending_per_claim_usd":2281.143678,"fact_id":"f3b4d215e61712b8559db524"}],"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":3,"all_states_medicaid_reimbursed_usd":5770557.95,"all_states_medicaid_paid_prescriptions":2653,"top_states":[{"state":"PR","medicaid_paid_prescriptions":2477,"medicaid_reimbursed_usd":5315313.51,"total_reimbursed_usd":5363906.16,"packages":1,"covers":"all_record_types","fact_id":"a9840bf57ce2adb80dddd2a9"},{"state":"CA","medicaid_paid_prescriptions":98,"medicaid_reimbursed_usd":230169.5,"total_reimbursed_usd":266575.47,"packages":1,"covers":"all_record_types","fact_id":"ee9e4b75a6965bafe1af6d4b"},{"state":"NY","medicaid_paid_prescriptions":78,"medicaid_reimbursed_usd":225074.94,"total_reimbursed_usd":226933.44,"packages":1,"covers":"all_record_types","fact_id":"ca28982b08f0621138d41da1"}],"unlabelled_state_code_xx":null,"built_from_facts":3,"facts_fee_for_service_only":0,"older_year_facts_not_used":80,"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":"1f51db3e5548ee82afb03a0e","field":"ndc.listing","entity":"ndc:61958200201"},{"fact_id":"ec33f15127936baa76e6dfd8","field":"ndc.listing","entity":"ndc:61958200202"},{"fact_id":"4b1974eafaf4b7dbacef1751","field":"ndc.listing","entity":"ndc:61958200501"},{"fact_id":"73d878c60ae98d5d91d90f0a","field":"drug.generic_entry_earliest","entity":"application:NDA208215"},{"fact_id":"e25e66228c629f584594cd54","field":"drug.patent","entity":"application:NDA208215"},{"fact_id":"c2ef4eddb0d8318e5009f147","field":"drug.exclusivity","entity":"application:NDA208215"},{"fact_id":"37d49691c5c199e5dcce7c3b","field":"drug.label_event","entity":"application:NDA208215"},{"fact_id":"fd6f18bc21ea5b31f6c0cced","field":"drug.label_event","entity":"application:NDA208215"},{"fact_id":"797b81fd9d36e118b6282012","field":"drug.label_event","entity":"application:NDA208215"},{"fact_id":"3da00404f0d7cd1debe62d53","field":"drug.label_event","entity":"application:NDA208215"},{"fact_id":"56781f744a3dec71816d1176","field":"drug.label_event","entity":"application:NDA208215"},{"fact_id":"f1be2f03a439aa05b8078f8c","field":"drug.te_code","entity":"application:NDA208215"},{"fact_id":"887d736494b2450eff820645","field":"drug.marketing_status","entity":"application:NDA208215"},{"fact_id":"c162948dfe2f7dc1de238ba8","field":"drug.te_code","entity":"application:NDA208215"},{"fact_id":"6469f50e7d06fb71f298a287","field":"drug.marketing_status","entity":"application:NDA208215"},{"fact_id":"44c0ef2415d99be7c7cada54","field":"program.offer","entity":"program:gilead-copay-savings-program"},{"fact_id":"9181f6d60c9501393a37d8a3","field":"drug.partd_spending","entity":"drug:emtricitabine-tenofov-alafenam|descovy"},{"fact_id":"725b2b842b60157f906949bb","field":"drug.partd_spending","entity":"drug:emtricitabine-tenofov-alafenam|descovy"},{"fact_id":"afbdc1cbf686b84a4ce726c3","field":"drug.partd_spending","entity":"drug:emtricitabine-tenofov-alafenam|descovy"},{"fact_id":"190147bd58d6ebcb5638dcfa","field":"drug.partd_spending","entity":"drug:emtricitabine-tenofov-alafenam|descovy"},{"fact_id":"f3b4d215e61712b8559db524","field":"drug.partd_spending","entity":"drug:emtricitabine-tenofov-alafenam|descovy"},{"fact_id":"a9840bf57ce2adb80dddd2a9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61958200201:PR"},{"fact_id":"ee9e4b75a6965bafe1af6d4b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61958200501:CA"},{"fact_id":"ca28982b08f0621138d41da1","field":"ndc.medicaid_state_utilization","entity":"ndc_state:61958200501:NY"}],"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."}