{"answer":{"query":"Xiidra","resolved_as":"applications","packages":4,"applications":["NDA208073"],"identity":{"application_numbers":["NDA208073"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION/ DROPS","untrusted":true}],"marketing_start":{"earliest":"2020-06-04","latest":"2024-01-02","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA208073","date":"2033-12-18","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":"11058677","productNo":"001"},"latest_patent_expiry":"2033-12-18","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":11,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":11,"exclusivities_listed":0,"fact_id":"00ba58af38e18c223863c4a6"}],"label_history":{"events_total":3,"non_cmc_events":2,"counts_by_class":{"LABELING":2},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA208073","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-06-04","documents":[{"type":"Label","date":"2020-06-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208073s005lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-06-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208073Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"872963aab26ffae617df3816"},{"application":"NDA208073","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-12-17","documents":[{"type":"Letter","date":"2017-12-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208073Orig1s002ltr.pdf","untrusted":true}},{"type":"Label","date":"2017-12-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208073s002lbl.pdf","untrusted":true}}],"fact_id":"d676a798656cd846118e9f44"}],"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":"NDA208073","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"XIIDRA","untrusted":true},"form":{"text":"SOLUTION/DROPS;OPHTHALMIC","untrusted":true},"strength":{"text":"5%","untrusted":true}}]},"recalls":{"recalls_total":2,"counts_by_class":{"Class III":2},"packages_of_these_applications":4,"most_recent":[{"recall_number":"D-0982-2022","classification":"Class III","status":"Terminated","report_date":"2022-06-15","recall_initiated":"2022-05-10","recalling_firm":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"reason":{"text":"Failed Impurities/Degradation Specifications.","untrusted":true},"packages_named":2,"fact_id":"a9c702c9bf71d01f6b26aa5b"},{"recall_number":"D-0984-2022","classification":"Class III","status":"Terminated","report_date":"2022-06-15","recall_initiated":"2022-05-10","recalling_firm":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"reason":{"text":"Failed Impurities/Degradation Specifications.","untrusted":true},"packages_named":2,"fact_id":"b3718e35951715533e68f990"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Lifitegrast","untrusted":true},"brand":{"text":"Xiidra","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":28032942.85,"claims":33017,"beneficiaries":74134,"average_spending_per_claim_usd":849.04572947,"fact_id":"d1553b9f644ce67d442b22e5"},{"year":2021,"gross_spending_usd":261124341.37,"claims":289474,"beneficiaries":99941,"average_spending_per_claim_usd":902.06492248,"fact_id":"2a4422703680224fff6bbbb2"},{"year":2022,"gross_spending_usd":332509805.71,"claims":330967,"beneficiaries":121062,"average_spending_per_claim_usd":1004.6615092,"fact_id":"e81fc3c92876177f698d12f8"},{"year":2023,"gross_spending_usd":472699910.94,"claims":420786,"beneficiaries":149642,"average_spending_per_claim_usd":1123.3736649,"fact_id":"55a07ae0c631093a4ef57da3"},{"year":2024,"gross_spending_usd":505334180.32,"claims":477354,"beneficiaries":166361,"average_spending_per_claim_usd":1058.6151584,"fact_id":"6477c4f02f0122dcf97348e5"}],"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":45,"all_states_medicaid_reimbursed_usd":79769203.2,"all_states_medicaid_paid_prescriptions":95171,"top_states":[{"state":"NY","medicaid_paid_prescriptions":33783,"medicaid_reimbursed_usd":31263258.61,"total_reimbursed_usd":31336071.65,"packages":1,"covers":"fee_for_service_only","fact_id":"efeba0c9fc9a0ad31844105d"},{"state":"CA","medicaid_paid_prescriptions":11636,"medicaid_reimbursed_usd":10798938.01,"total_reimbursed_usd":11008911.84,"packages":1,"covers":"all_record_types","fact_id":"2de5d945d91be43b448d23d7"},{"state":"CT","medicaid_paid_prescriptions":7350,"medicaid_reimbursed_usd":5099025.14,"total_reimbursed_usd":5182240.38,"packages":1,"covers":"all_record_types","fact_id":"08603c7a17bc77643827a912"},{"state":"PA","medicaid_paid_prescriptions":4225,"medicaid_reimbursed_usd":3610766.88,"total_reimbursed_usd":3674992.63,"packages":1,"covers":"fee_for_service_only","fact_id":"d13f82434914f2d760ee8bf0"},{"state":"NJ","medicaid_paid_prescriptions":3218,"medicaid_reimbursed_usd":2532296.11,"total_reimbursed_usd":2565230.46,"packages":1,"covers":"fee_for_service_only","fact_id":"0290af66c0395ae42477ad15"},{"state":"LA","medicaid_paid_prescriptions":3623,"medicaid_reimbursed_usd":2448838.27,"total_reimbursed_usd":2537464.62,"packages":1,"covers":"fee_for_service_only","fact_id":"37c891b8d7e462a55d13b776"},{"state":"IN","medicaid_paid_prescriptions":2554,"medicaid_reimbursed_usd":2393287.77,"total_reimbursed_usd":2396108.7,"packages":1,"covers":"all_record_types","fact_id":"fca96f4e27061e81499bb3bf"},{"state":"KY","medicaid_paid_prescriptions":2868,"medicaid_reimbursed_usd":2391355.33,"total_reimbursed_usd":2391355.33,"packages":1,"covers":"fee_for_service_only","fact_id":"9a6bf34b8b287fe48de9c5b9"},{"state":"VA","medicaid_paid_prescriptions":3232,"medicaid_reimbursed_usd":2191284.26,"total_reimbursed_usd":2219153.26,"packages":1,"covers":"fee_for_service_only","fact_id":"290e6ca2fa8f1c620986b281"},{"state":"MI","medicaid_paid_prescriptions":2618,"medicaid_reimbursed_usd":1776118.85,"total_reimbursed_usd":1800879.52,"packages":1,"covers":"all_record_types","fact_id":"6a6f539afe083bc944c5e6ac"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":96107,"medicaid_reimbursed_usd":80456508.74,"note":"the source uses the code XX without defining it; 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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":"f386849dc130095d21743174","field":"ndc.listing","entity":"ndc:00078091112"},{"fact_id":"c6bc92a75e5c3a939c5663e1","field":"ndc.listing","entity":"ndc:00078091194"},{"fact_id":"830fceea7414dd2d71ee6f4d","field":"ndc.listing","entity":"ndc:24208091112"},{"fact_id":"00ba58af38e18c223863c4a6","field":"drug.generic_entry_earliest","entity":"application:NDA208073"},{"fact_id":"b73a6a8a0af0bd7557f02e31","field":"drug.patent","entity":"application:NDA208073"},{"fact_id":"872963aab26ffae617df3816","field":"drug.label_event","entity":"application:NDA208073"},{"fact_id":"d676a798656cd846118e9f44","field":"drug.label_event","entity":"application:NDA208073"},{"fact_id":"13de7e62812caa353192435c","field":"drug.te_code","entity":"application:NDA208073"},{"fact_id":"1e0617b0c47e57d6855e830d","field":"drug.marketing_status","entity":"application:NDA208073"},{"fact_id":"a9c702c9bf71d01f6b26aa5b","field":"ndc.recall","entity":"ndc:00078091112"},{"fact_id":"b3718e35951715533e68f990","field":"ndc.recall","entity":"ndc:00078091194"},{"fact_id":"d1553b9f644ce67d442b22e5","field":"drug.partd_spending","entity":"drug:lifitegrast|xiidra"},{"fact_id":"2a4422703680224fff6bbbb2","field":"drug.partd_spending","entity":"drug:lifitegrast|xiidra"},{"fact_id":"e81fc3c92876177f698d12f8","field":"drug.partd_spending","entity":"drug:lifitegrast|xiidra"},{"fact_id":"55a07ae0c631093a4ef57da3","field":"drug.partd_spending","entity":"drug:lifitegrast|xiidra"},{"fact_id":"6477c4f02f0122dcf97348e5","field":"drug.partd_spending","entity":"drug:lifitegrast|xiidra"},{"fact_id":"efeba0c9fc9a0ad31844105d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208091112:NY"},{"fact_id":"2de5d945d91be43b448d23d7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208091112:CA"},{"fact_id":"08603c7a17bc77643827a912","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208091112:CT"},{"fact_id":"d13f82434914f2d760ee8bf0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208091112:PA"},{"fact_id":"0290af66c0395ae42477ad15","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208091112:NJ"},{"fact_id":"37c891b8d7e462a55d13b776","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208091112:LA"},{"fact_id":"fca96f4e27061e81499bb3bf","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208091112:IN"},{"fact_id":"9a6bf34b8b287fe48de9c5b9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208091112:KY"},{"fact_id":"290e6ca2fa8f1c620986b281","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208091112:VA"},{"fact_id":"6a6f539afe083bc944c5e6ac","field":"ndc.medicaid_state_utilization","entity":"ndc_state:24208091112:MI"}],"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":"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."}