{"answer":{"query":"Vyzulta","resolved_as":"applications","packages":4,"applications":["NDA207795"],"identity":{"application_numbers":["NDA207795"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION/ DROPS","untrusted":true}],"marketing_start":{"earliest":"2017-11-02","latest":"2018-06-11","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA207795","date":"2029-02-21","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":"8058467","productNo":"001"},"latest_patent_expiry":"2029-02-21","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":1,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":0,"fact_id":"25b767f5119379070d391654"}],"label_history":{"events_total":1,"non_cmc_events":1,"counts_by_class":{"LABELING":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA207795","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-06-11","documents":[{"type":"Letter","date":"2018-06-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/207795Orig1s002ltr.pdf","untrusted":true}},{"type":"Label","date":"2018-06-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/207795s002lbl.pdf","untrusted":true}}],"fact_id":"d59f54c07cb9b055268d3e54"}],"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":"NDA207795","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VYZULTA","untrusted":true},"form":{"text":"SOLUTION/DROPS;OPHTHALMIC","untrusted":true},"strength":{"text":"0.024%","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Latanoprostene Bunod","untrusted":true},"brand":{"text":"Vyzulta","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":37642502.51,"claims":101073,"beneficiaries":28139,"average_spending_per_claim_usd":372.4288634,"fact_id":"936f5d433d84dc6e20c2869c"},{"year":2021,"gross_spending_usd":57633322.13,"claims":146081,"beneficiaries":42401,"average_spending_per_claim_usd":394.52989869,"fact_id":"029070e3fed3a42d73fb26bc"},{"year":2022,"gross_spending_usd":86520403.37,"claims":206403,"beneficiaries":57544,"average_spending_per_claim_usd":419.18190806,"fact_id":"b6c22e6c27e2e03aabf8e0dd"},{"year":2023,"gross_spending_usd":117369727.63,"claims":261217,"beneficiaries":69308,"average_spending_per_claim_usd":449.3188714,"fact_id":"e0c67aa60e66a2eed8b2e51f"},{"year":2024,"gross_spending_usd":128286737.76,"claims":292207,"beneficiaries":75825,"average_spending_per_claim_usd":439.02691503,"fact_id":"d76f472c2eff3ab9de620dd7"}],"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":2,"all_states_medicaid_reimbursed_usd":64213.71,"all_states_medicaid_paid_prescriptions":154,"top_states":[{"state":"MA","medicaid_paid_prescriptions":92,"medicaid_reimbursed_usd":46416.75,"total_reimbursed_usd":46416.75,"packages":1,"covers":"fee_for_service_only","fact_id":"b9bcb5a39b533d12a55a83e0"},{"state":"MN","medicaid_paid_prescriptions":62,"medicaid_reimbursed_usd":17796.96,"total_reimbursed_usd":17796.96,"packages":1,"covers":"fee_for_service_only","fact_id":"efa8bf989f1fc5b6b197f281"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":2,"older_year_facts_not_used":43,"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":"95695091a63ce99161093ab5","field":"ndc.listing","entity":"ndc:24208050401"},{"fact_id":"67042b0815b2b1eed2430a1b","field":"ndc.listing","entity":"ndc:24208050402"},{"fact_id":"d4a5481d69dc55d6256cdb46","field":"ndc.listing","entity":"ndc:24208050405"},{"fact_id":"25b767f5119379070d391654","field":"drug.generic_entry_earliest","entity":"application:NDA207795"},{"fact_id":"1cae52e803e9d41d861c10a7","field":"drug.patent","entity":"application:NDA207795"},{"fact_id":"d59f54c07cb9b055268d3e54","field":"drug.label_event","entity":"application:NDA207795"},{"fact_id":"cf8bd41209bbd6a59680f08b","field":"drug.te_code","entity":"application:NDA207795"},{"fact_id":"96eee08515ad7a11168649af","field":"drug.marketing_status","entity":"application:NDA207795"},{"fact_id":"936f5d433d84dc6e20c2869c","field":"drug.partd_spending","entity":"drug:latanoprostene-bunod|vyzulta"},{"fact_id":"029070e3fed3a42d73fb26bc","field":"drug.partd_spending","entity":"drug:latanoprostene-bunod|vyzulta"},{"fact_id":"b6c22e6c27e2e03aabf8e0dd","field":"drug.partd_spending","entity":"drug:latanoprostene-bunod|vyzulta"},{"fact_id":"e0c67aa60e66a2eed8b2e51f","field":"drug.partd_spending","entity":"drug:latanoprostene-bunod|vyzulta"},{"fact_id":"d76f472c2eff3ab9de620dd7","field":"drug.partd_spending","entity":"drug:latanoprostene-bunod|vyzulta"},{"fact_id":"b9bcb5a39b533d12a55a83e0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208050405:MA"},{"fact_id":"efa8bf989f1fc5b6b197f281","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208050402:MN"}],"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":"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."}