{"answer":{"query":"Oxervate","resolved_as":"applications","packages":2,"applications":["BLA761094"],"identity":{"application_numbers":["BLA761094"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"KIT","untrusted":true},{"text":"SOLUTION/ DROPS","untrusted":true}],"marketing_start":{"earliest":"2018-11-26","latest":"2018-11-26","packages_with_a_start_date":2}},"label_history":{"events_total":3,"non_cmc_events":3,"counts_by_class":{"LABELING":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA761094","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-10-20","documents":[{"type":"Letter","date":"2023-10-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761094Orig1s012; 013ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-10-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761094s012s013lbl.pdf","untrusted":true}}],"fact_id":"fe98c37d7c4f88f9f8d591d2"},{"application":"BLA761094","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-10-20","documents":[{"type":"Letter","date":"2023-10-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761094Orig1s012; 013ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-10-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761094s012s013lbl.pdf","untrusted":true}}],"fact_id":"1b3669d9de91175cba509568"},{"application":"BLA761094","submission_no":1,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-10-30","documents":[{"type":"Letter","date":"2019-10-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761094Orig1s001ltr.pdf","untrusted":true}},{"type":"Label","date":"2019-10-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761094s001lbl.pdf","untrusted":true}}],"fact_id":"20cf473039c93c9065fbbf34"}],"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":{"NOT_PROVIDED":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":"BLA761094","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"OXERVATE","untrusted":true},"form":{"text":"SOLUTION;OPHTHALMIC","untrusted":true},"strength":{"text":"0.002%(20MCG/ML)","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Cenegermin-Bkbj","untrusted":true},"brand":{"text":"Oxervate","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":215418306.63,"claims":7358,"beneficiaries":1895,"average_spending_per_claim_usd":29276.7473,"fact_id":"fd3c20fe9df37035ab0c8f3d"},{"year":2021,"gross_spending_usd":274796160.56,"claims":8854,"beneficiaries":2265,"average_spending_per_claim_usd":31036.385878,"fact_id":"1b342494a404df0baa1821e0"},{"year":2022,"gross_spending_usd":367261094.1,"claims":10792,"beneficiaries":2803,"average_spending_per_claim_usd":34030.864909,"fact_id":"7b276b37ebd6110d0a5cb1c0"},{"year":2023,"gross_spending_usd":493161480.5,"claims":13460,"beneficiaries":3526,"average_spending_per_claim_usd":36639.040156,"fact_id":"51dfd1fe9ec60e955555d38d"},{"year":2024,"gross_spending_usd":714549320.33,"claims":18294,"beneficiaries":4781,"average_spending_per_claim_usd":39059.217248,"fact_id":"40bd0dfa0af3797e9dea0ab9"}],"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}}},"biologic_status":{"products":[{"application":"BLA761094","status":"Reference","name":{"text":"Oxervate","untrusted":true},"proper_name":{"text":"cenegermin-bkbj","untrusted":true},"license_status":"Licensed","approval_date":"2018-08-22","reference_product":null,"interchangeable_date":null,"biosimilars_listed":0,"interchangeables_listed":0,"biosimilars":[],"interchangeables":[],"purple_book_version":"purplebook-2026-10","read_on":"2026-11-07T07:33:31.186Z","fact_id":"c026461e2f9d17a8d1550e38"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"cenegermin-bkbj","untrusted":true},"designation_count":2,"approved_count":1,"recent":[{"designated":"2024-10-28","use":{"text":"treatment of neonatal hypoxic ischemic encephalopathy","untrusted":true},"status":"Designated","sponsor":{"text":"Dompé farmaceutici S.p.A.","untrusted":true},"approved":false},{"designated":"2014-06-23","use":{"text":"Treatment of neurotrophic keratitis","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Dompe S.p.A.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"2fc58a10363d4d0532d5d792"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":3,"all_states_medicaid_reimbursed_usd":9568449.53,"all_states_medicaid_paid_prescriptions":222,"top_states":[{"state":"CT","medicaid_paid_prescriptions":105,"medicaid_reimbursed_usd":5302239.25,"total_reimbursed_usd":5302239.25,"packages":1,"covers":"all_record_types","fact_id":"c721ac71899b94f361acade0"},{"state":"NC","medicaid_paid_prescriptions":71,"medicaid_reimbursed_usd":2539022.78,"total_reimbursed_usd":2655510.54,"packages":1,"covers":"all_record_types","fact_id":"9df0c2d99de9bfa04281b249"},{"state":"WV","medicaid_paid_prescriptions":46,"medicaid_reimbursed_usd":1727187.5,"total_reimbursed_usd":1727187.5,"packages":1,"covers":"all_record_types","fact_id":"4683259b6ef625bbaa8fe9fc"}],"unlabelled_state_code_xx":null,"built_from_facts":3,"facts_fee_for_service_only":0,"older_year_facts_not_used":7,"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":"e7d40c3880bdbf0b2964e5cd","field":"ndc.listing","entity":"ndc:71981000101"},{"fact_id":"3b4b2c6ca9465897a94a48cb","field":"ndc.listing","entity":"ndc:71981002007"},{"fact_id":"fe98c37d7c4f88f9f8d591d2","field":"drug.label_event","entity":"application:BLA761094"},{"fact_id":"1b3669d9de91175cba509568","field":"drug.label_event","entity":"application:BLA761094"},{"fact_id":"20cf473039c93c9065fbbf34","field":"drug.label_event","entity":"application:BLA761094"},{"fact_id":"42415e75e1845cb021382139","field":"drug.marketing_status","entity":"application:BLA761094"},{"fact_id":"fd3c20fe9df37035ab0c8f3d","field":"drug.partd_spending","entity":"drug:cenegermin-bkbj|oxervate"},{"fact_id":"1b342494a404df0baa1821e0","field":"drug.partd_spending","entity":"drug:cenegermin-bkbj|oxervate"},{"fact_id":"7b276b37ebd6110d0a5cb1c0","field":"drug.partd_spending","entity":"drug:cenegermin-bkbj|oxervate"},{"fact_id":"51dfd1fe9ec60e955555d38d","field":"drug.partd_spending","entity":"drug:cenegermin-bkbj|oxervate"},{"fact_id":"40bd0dfa0af3797e9dea0ab9","field":"drug.partd_spending","entity":"drug:cenegermin-bkbj|oxervate"},{"fact_id":"c026461e2f9d17a8d1550e38","field":"drug.biologic_status","entity":"application:BLA761094"},{"fact_id":"2fc58a10363d4d0532d5d792","field":"drug.orphan_designation","entity":"drug:cenegermin-bkbj"},{"fact_id":"c721ac71899b94f361acade0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:71981002007:CT"},{"fact_id":"9df0c2d99de9bfa04281b249","field":"ndc.medicaid_state_utilization","entity":"ndc_state:71981002007:NC"},{"fact_id":"4683259b6ef625bbaa8fe9fc","field":"ndc.medicaid_state_utilization","entity":"ndc_state:71981002007:WV"}],"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":"generic_entry:BLA761094","reason":"no generic-entry fact for this application: no patent or exclusivity is listed for it in the Orange Book edition read, so no date is stated"},{"code":"NO_DATA","field":"generic_entry","reason":"no application of this drug has a generic-entry fact; no date is stated"},{"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":"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":"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."}