{"answer":{"query":"Vascepa","resolved_as":"applications","packages":9,"applications":["NDA202057"],"identity":{"application_numbers":["NDA202057"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true}],"marketing_start":{"earliest":"2012-10-01","latest":"2026-04-07","packages_with_a_start_date":9}},"generic_entry":[{"application":"NDA202057","date":"2033-06-28","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":"10278935","productNo":"001"},"latest_patent_expiry":"2033-06-28","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":119,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":61,"exclusivities_listed":0,"fact_id":"035cb2450caf4e02d272d5bd"}],"label_history":{"events_total":18,"non_cmc_events":2,"counts_by_class":{"EFFICACY":1,"LABELING":1},"cmc_events":16,"recent_non_cmc_events":[{"application":"NDA202057","submission_no":35,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2019-12-13","documents":[{"type":"Label","date":"2019-12-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202057s035lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-12-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202057Orig1s035ltr.pdf","untrusted":true}}],"fact_id":"5a8f0cc8561a54bbc8cd0152"},{"application":"NDA202057","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2013-11-25","documents":[{"type":"Letter","date":"2013-11-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202057Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2013-11-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202057s009lbl.pdf","untrusted":true}}],"fact_id":"7a93bd39b1cc5383c14f0e3a"}],"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":"NDA202057","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VASCEPA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"500MG","untrusted":true}},{"application":"NDA202057","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"VASCEPA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"1GM","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Icosapent Ethyl","untrusted":true},"brand":{"text":"Vascepa","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":754811701.2,"claims":1711456,"beneficiaries":333614,"average_spending_per_claim_usd":441.03482719,"fact_id":"162375bf0c6ab446c2ae4227"},{"year":2021,"gross_spending_usd":831994327.51,"claims":1698206,"beneficiaries":344027,"average_spending_per_claim_usd":489.92544339,"fact_id":"be969e9a2e8b96232543fb17"},{"year":2022,"gross_spending_usd":787854458.4,"claims":1527133,"beneficiaries":303971,"average_spending_per_claim_usd":515.90428496,"fact_id":"93b69ceecfef13d1456dbd47"},{"year":2023,"gross_spending_usd":763988446.53,"claims":1424930,"beneficiaries":279946,"average_spending_per_claim_usd":536.15858079,"fact_id":"35651d92576dd3d34b5a0a28"},{"year":2024,"gross_spending_usd":724180333.53,"claims":1474990,"beneficiaries":301070,"average_spending_per_claim_usd":490.97304628,"fact_id":"5045b584f55676b3b18a6c29"}],"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":2024,"states_with_data":8,"all_states_medicaid_reimbursed_usd":4646676.38,"all_states_medicaid_paid_prescriptions":11946,"top_states":[{"state":"FL","medicaid_paid_prescriptions":3866,"medicaid_reimbursed_usd":1315145.22,"total_reimbursed_usd":1325202.45,"packages":1,"covers":"all_record_types","fact_id":"5975e0ccb01f474cf5c25944"},{"state":"CT","medicaid_paid_prescriptions":3299,"medicaid_reimbursed_usd":1210674.63,"total_reimbursed_usd":1215166.02,"packages":1,"covers":"all_record_types","fact_id":"8998313547bce513f6a50e7a"},{"state":"WV","medicaid_paid_prescriptions":2124,"medicaid_reimbursed_usd":947605.69,"total_reimbursed_usd":960492.9,"packages":1,"covers":"all_record_types","fact_id":"79c6ec79596ab3fd886166ea"},{"state":"NC","medicaid_paid_prescriptions":1437,"medicaid_reimbursed_usd":650367.38,"total_reimbursed_usd":686829.29,"packages":1,"covers":"fee_for_service_only","fact_id":"67ad16a26d9b99389fa8393a"},{"state":"NE","medicaid_paid_prescriptions":414,"medicaid_reimbursed_usd":180952.03,"total_reimbursed_usd":180952.03,"packages":1,"covers":"all_record_types","fact_id":"284dabc3a3b04f5216a4edf2"},{"state":"TN","medicaid_paid_prescriptions":390,"medicaid_reimbursed_usd":126267.31,"total_reimbursed_usd":127840,"packages":1,"covers":"all_record_types","fact_id":"bdf1af37f879437ab9b7969f"},{"state":"IN","medicaid_paid_prescriptions":284,"medicaid_reimbursed_usd":122057.99,"total_reimbursed_usd":122057.99,"packages":1,"covers":"fee_for_service_only","fact_id":"fead0f789d1ff403a64776a7"},{"state":"MA","medicaid_paid_prescriptions":132,"medicaid_reimbursed_usd":93606.13,"total_reimbursed_usd":99069.79,"packages":1,"covers":"fee_for_service_only","fact_id":"2a0719b8c88d2da403e535f9"}],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":111741,"medicaid_reimbursed_usd":45654273.19,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":9,"facts_fee_for_service_only":3,"older_year_facts_not_used":0,"dataset":"State Drug Utilization Data 2024","read_on":"2026-11-07T23:59:45.983Z","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":"f2c2e6f95bfa0216ffe0e115","field":"ndc.listing","entity":"ndc:52937000120"},{"fact_id":"e54852b86e11a49ba62bdd6f","field":"ndc.listing","entity":"ndc:52937000316"},{"fact_id":"b1792c7d7fb6141a460756f1","field":"ndc.listing","entity":"ndc:52937000340"},{"fact_id":"035cb2450caf4e02d272d5bd","field":"drug.generic_entry_earliest","entity":"application:NDA202057"},{"fact_id":"70c4e2779253826d94dbd7b9","field":"drug.patent","entity":"application:NDA202057"},{"fact_id":"5a8f0cc8561a54bbc8cd0152","field":"drug.label_event","entity":"application:NDA202057"},{"fact_id":"7a93bd39b1cc5383c14f0e3a","field":"drug.label_event","entity":"application:NDA202057"},{"fact_id":"d4e4bf9fde861adec56ca59c","field":"drug.te_code","entity":"application:NDA202057"},{"fact_id":"8d99bfa599e200b56ad8e3c1","field":"drug.marketing_status","entity":"application:NDA202057"},{"fact_id":"089e2dc44ab3dcd90c5c76e1","field":"drug.te_code","entity":"application:NDA202057"},{"fact_id":"a74b69ab4f016e5f36e4b24c","field":"drug.marketing_status","entity":"application:NDA202057"},{"fact_id":"162375bf0c6ab446c2ae4227","field":"drug.partd_spending","entity":"drug:icosapent-ethyl|vascepa"},{"fact_id":"be969e9a2e8b96232543fb17","field":"drug.partd_spending","entity":"drug:icosapent-ethyl|vascepa"},{"fact_id":"93b69ceecfef13d1456dbd47","field":"drug.partd_spending","entity":"drug:icosapent-ethyl|vascepa"},{"fact_id":"35651d92576dd3d34b5a0a28","field":"drug.partd_spending","entity":"drug:icosapent-ethyl|vascepa"},{"fact_id":"5045b584f55676b3b18a6c29","field":"drug.partd_spending","entity":"drug:icosapent-ethyl|vascepa"},{"fact_id":"5975e0ccb01f474cf5c25944","field":"ndc.medicaid_state_utilization","entity":"ndc_state:52937000120:FL"},{"fact_id":"8998313547bce513f6a50e7a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:52937000120:CT"},{"fact_id":"79c6ec79596ab3fd886166ea","field":"ndc.medicaid_state_utilization","entity":"ndc_state:52937000120:WV"},{"fact_id":"67ad16a26d9b99389fa8393a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:52937000120:NC"},{"fact_id":"284dabc3a3b04f5216a4edf2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:52937000120:NE"},{"fact_id":"bdf1af37f879437ab9b7969f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:52937000120:TN"},{"fact_id":"fead0f789d1ff403a64776a7","field":"ndc.medicaid_state_utilization","entity":"ndc_state:52937000120:IN"},{"fact_id":"2a0719b8c88d2da403e535f9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:52937000120:MA"}],"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":"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."}