{"answer":{"query":"Lumigan","resolved_as":"applications","packages":4,"applications":["NDA022184"],"identity":{"application_numbers":["NDA022184"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION/ DROPS","untrusted":true}],"marketing_start":{"earliest":"2010-09-10","latest":"2010-09-10","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA022184","date":"2027-06-13","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":"7851504","productNo":"001"},"latest_patent_expiry":"2027-06-13","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":1,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":0,"fact_id":"ec845d562ea9894413faec22"}],"label_history":{"events_total":7,"non_cmc_events":5,"counts_by_class":{"LABELING":5},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA022184","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-03-08","documents":[{"type":"Letter","date":"2022-03-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022184Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-03-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022184s009lbl.pdf","untrusted":true}}],"fact_id":"bbaa23837c7a43410f86cc8b"},{"application":"NDA022184","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-09-29","documents":[{"type":"Letter","date":"2020-09-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022184Orig1s008ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-10-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022184s008lbl.pdf","untrusted":true}}],"fact_id":"8a3d26092c80732576f5664b"},{"application":"NDA022184","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-07-29","documents":[{"type":"Label","date":"2017-07-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022184s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-08-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022184Orig1s006ltr.pdf","untrusted":true}}],"fact_id":"39cac34abfa03bec028638a4"},{"application":"NDA022184","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2014-09-29","documents":[{"type":"Letter","date":"2014-10-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022184Orig1s005ltr.pdf","untrusted":true}},{"type":"Label","date":"2014-09-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022184s005lbl.pdf","untrusted":true}}],"fact_id":"f898920e59f271d9c74d5372"},{"application":"NDA022184","submission_no":1,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2012-03-15","documents":[{"type":"Label","date":"2012-03-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022184s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2012-03-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022184s001ltr.pdf","untrusted":true}}],"fact_id":"bd4b8fa46932848966030b0a"}],"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":"NDA022184","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"LUMIGAN","untrusted":true},"form":{"text":"SOLUTION/DROPS;OPHTHALMIC","untrusted":true},"strength":{"text":"0.01%","untrusted":true}}]},"recalls":{"recalls_total":2,"counts_by_class":{"Class III":2},"packages_of_these_applications":4,"most_recent":[{"recall_number":"D-0078-2018","classification":"Class III","status":"Terminated","report_date":"2017-11-22","recall_initiated":"2017-10-19","recalling_firm":{"text":"Allergan Sales, LLC","untrusted":true},"reason":{"text":"Failed Impurities/Degradation Specifications.","untrusted":true},"packages_named":4,"fact_id":"fc5c5fb5e92eda8cc8b0e0ae"},{"recall_number":"D-0667-2017","classification":"Class III","status":"Terminated","report_date":"2017-04-19","recall_initiated":"2017-03-16","recalling_firm":{"text":"Allergan Sales, LLC","untrusted":true},"reason":{"text":"Failed Impurities/Degradation Specifications","untrusted":true},"packages_named":4,"fact_id":"e56605412a0e9b7dd19173b4"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Bimatoprost","untrusted":true},"brand":{"text":"Lumigan","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":633540095.98,"claims":1718576,"beneficiaries":382851,"average_spending_per_claim_usd":368.64246677,"fact_id":"466237b82e3221f6bb4f793a"},{"year":2021,"gross_spending_usd":668670324.97,"claims":1674825,"beneficiaries":388372,"average_spending_per_claim_usd":399.24787663,"fact_id":"c0997d12a76737709e1e2ee3"},{"year":2022,"gross_spending_usd":701339025.04,"claims":1606849,"beneficiaries":366333,"average_spending_per_claim_usd":436.46853254,"fact_id":"2ecce09ee1003df8c4d27e7d"},{"year":2023,"gross_spending_usd":697002199.46,"claims":1480360,"beneficiaries":347753,"average_spending_per_claim_usd":470.83290514,"fact_id":"c4128ee63c4dc278dae55b67"},{"year":2024,"gross_spending_usd":647209310.14,"claims":1407999,"beneficiaries":336870,"average_spending_per_claim_usd":459.66602969,"fact_id":"1c2f9a552d1cf4c2f65a2363"}],"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":5,"all_states_medicaid_reimbursed_usd":177595.39,"all_states_medicaid_paid_prescriptions":311,"top_states":[{"state":"NC","medicaid_paid_prescriptions":75,"medicaid_reimbursed_usd":56579.56,"total_reimbursed_usd":58146.16,"packages":1,"covers":"fee_for_service_only","fact_id":"7450d74b4ced5edbc1f8b3d3"},{"state":"OK","medicaid_paid_prescriptions":53,"medicaid_reimbursed_usd":40621.39,"total_reimbursed_usd":40749.39,"packages":1,"covers":"fee_for_service_only","fact_id":"61b59067bb00019fb12058c9"},{"state":"IN","medicaid_paid_prescriptions":67,"medicaid_reimbursed_usd":34051.84,"total_reimbursed_usd":34051.84,"packages":1,"covers":"fee_for_service_only","fact_id":"a02c6150c7ddc605b4f0ecb2"},{"state":"AR","medicaid_paid_prescriptions":61,"medicaid_reimbursed_usd":31368.11,"total_reimbursed_usd":31368.11,"packages":1,"covers":"fee_for_service_only","fact_id":"51ff823de187ac7c090395d3"},{"state":"UT","medicaid_paid_prescriptions":55,"medicaid_reimbursed_usd":14974.49,"total_reimbursed_usd":14974.49,"packages":1,"covers":"fee_for_service_only","fact_id":"986c1ca376aff801c3aa5258"}],"unlabelled_state_code_xx":null,"built_from_facts":5,"facts_fee_for_service_only":5,"older_year_facts_not_used":63,"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":"cb6bfeac60df3bf81e4ff44f","field":"ndc.listing","entity":"ndc:00023320502"},{"fact_id":"2a08a318ff0ba8d7eab5a521","field":"ndc.listing","entity":"ndc:00023320503"},{"fact_id":"796959b751af240adbcaf481","field":"ndc.listing","entity":"ndc:00023320505"},{"fact_id":"ec845d562ea9894413faec22","field":"drug.generic_entry_earliest","entity":"application:NDA022184"},{"fact_id":"5b504ff237f1e7a072b6be96","field":"drug.patent","entity":"application:NDA022184"},{"fact_id":"bbaa23837c7a43410f86cc8b","field":"drug.label_event","entity":"application:NDA022184"},{"fact_id":"8a3d26092c80732576f5664b","field":"drug.label_event","entity":"application:NDA022184"},{"fact_id":"39cac34abfa03bec028638a4","field":"drug.label_event","entity":"application:NDA022184"},{"fact_id":"f898920e59f271d9c74d5372","field":"drug.label_event","entity":"application:NDA022184"},{"fact_id":"bd4b8fa46932848966030b0a","field":"drug.label_event","entity":"application:NDA022184"},{"fact_id":"ebada928d636918204ec5779","field":"drug.te_code","entity":"application:NDA022184"},{"fact_id":"3db2c24546e5b6f378dcfb25","field":"drug.marketing_status","entity":"application:NDA022184"},{"fact_id":"fc5c5fb5e92eda8cc8b0e0ae","field":"ndc.recall","entity":"ndc:00023320505"},{"fact_id":"e56605412a0e9b7dd19173b4","field":"ndc.recall","entity":"ndc:00023320505"},{"fact_id":"466237b82e3221f6bb4f793a","field":"drug.partd_spending","entity":"drug:bimatoprost|lumigan"},{"fact_id":"c0997d12a76737709e1e2ee3","field":"drug.partd_spending","entity":"drug:bimatoprost|lumigan"},{"fact_id":"2ecce09ee1003df8c4d27e7d","field":"drug.partd_spending","entity":"drug:bimatoprost|lumigan"},{"fact_id":"c4128ee63c4dc278dae55b67","field":"drug.partd_spending","entity":"drug:bimatoprost|lumigan"},{"fact_id":"1c2f9a552d1cf4c2f65a2363","field":"drug.partd_spending","entity":"drug:bimatoprost|lumigan"},{"fact_id":"7450d74b4ced5edbc1f8b3d3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023320508:NC"},{"fact_id":"61b59067bb00019fb12058c9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023320508:OK"},{"fact_id":"a02c6150c7ddc605b4f0ecb2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023320505:IN"},{"fact_id":"51ff823de187ac7c090395d3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023320505:AR"},{"fact_id":"986c1ca376aff801c3aa5258","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023320503:UT"}],"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":"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":"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."}