{"answer":{"query":"Zenpep","resolved_as":"applications","packages":14,"applications":["BLA022210"],"identity":{"application_numbers":["BLA022210"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE, DELAYED RELEASE","untrusted":true}],"marketing_start":{"earliest":"2020-11-01","latest":"2023-10-27","packages_with_a_start_date":14}},"label_history":{"events_total":13,"non_cmc_events":7,"counts_by_class":{"LABELING":6,"REMS":1},"cmc_events":6,"recent_non_cmc_events":[{"application":"BLA022210","submission_no":26,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-02-28","documents":[{"type":"Letter","date":"2024-02-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022210Orig1s026ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-02-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022210s026lbl.pdf","untrusted":true}}],"fact_id":"8cdde49962f7abc08099670d"},{"application":"BLA022210","submission_no":27,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-10-27","documents":[{"type":"Letter","date":"2023-10-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022210Orig1s027ltr.pdf","untrusted":true}}],"fact_id":"a356c7e41b547ecc84fce0e4"},{"application":"BLA022210","submission_no":24,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-09-28","documents":[{"type":"Label","date":"2022-12-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022210Orig1s024_CorrectedLbl.pdf","untrusted":true}},{"type":"Letter","date":"2022-12-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022210Orig1s024CorrectedLtr.pdf","untrusted":true}}],"fact_id":"7978c4a229b8a7745f5f1683"},{"application":"BLA022210","submission_no":21,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-03-20","documents":[{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022210s021lbl.pdf","untrusted":true}}],"fact_id":"91474150d9927f6a274d834a"},{"application":"BLA022210","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2013-04-11","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022210Orig1s009,s012ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022210s009s012lbl.pdf","untrusted":true}}],"fact_id":"21370796039877761ee4465f"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":8,"te_code_counts":{"NOT_PROVIDED":8},"marketing_status_counts":{"Prescription":8},"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":"BLA022210","product_no":"005","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ZENPEP","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"14,000USP UNITS;3,000USP UNITS;10,000USP UNITS","untrusted":true}},{"application":"BLA022210","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ZENPEP","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"84,000USP UNITS;20,000USP UNITS;63,000USP UNITS","untrusted":true}},{"application":"BLA022210","product_no":"007","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ZENPEP","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"168,000USP UNITS;40,000USP UNITS;126,000USP UNITS","untrusted":true}},{"application":"BLA022210","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ZENPEP","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"24,000USP UNITS;5,000USP UNITS;17,000USP UNITS","untrusted":true}},{"application":"BLA022210","product_no":"008","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ZENPEP","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"252,600USP UNITS;60,000USP UNITS;189,600USP UNITS","untrusted":true}},{"application":"BLA022210","product_no":"006","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ZENPEP","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"105,000USP UNITS;25,000USP UNITS;79,000USP UNITS","untrusted":true}},{"application":"BLA022210","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ZENPEP","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"63,000USP UNITS;15,000USP UNITS;47,000USP UNITS","untrusted":true}},{"application":"BLA022210","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ZENPEP","untrusted":true},"form":{"text":"CAPSULE, DELAYED RELEASE;ORAL","untrusted":true},"strength":{"text":"42,000USP UNITS;10,000USP UNITS;32,000USP UNITS","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Lipase/Protease/Amylase","untrusted":true},"brand":{"text":"Zenpep","untrusted":true}},"latest_year":2024,"series":[{"year":2021,"gross_spending_usd":143420728.4,"claims":67668,"beneficiaries":35828,"average_spending_per_claim_usd":2119.4763906,"fact_id":"09a46c9d10dcb32933bdde87"},{"year":2022,"gross_spending_usd":328785215.53,"claims":159064,"beneficiaries":39178,"average_spending_per_claim_usd":2066.9995444,"fact_id":"ad5fdb739204fbc386b6ab1e"},{"year":2023,"gross_spending_usd":442806701.76,"claims":189873,"beneficiaries":46322,"average_spending_per_claim_usd":2332.1204266,"fact_id":"349584e97d55a271e5a4e960"},{"year":2024,"gross_spending_usd":597436409.02,"claims":259162,"beneficiaries":58375,"average_spending_per_claim_usd":2305.2623804,"fact_id":"37497e0d0e5ebf51a167a323"}],"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":"BLA022210","status":"Reference","name":{"text":"Zenpep","untrusted":true},"proper_name":{"text":"pancrelipase","untrusted":true},"license_status":"Licensed","approval_date":"2009-08-27","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":"cbf78a6c43084e9d70c18365"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"rems":{"programs":[{"application":"BLA022210","program":{"text":"Zenpep","untrusted":true},"rems_id":"300","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":false,"program_date":"2009-08-27","last_modified":"2011-06-10","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=300","other_programs":0,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"9d3bb1540a17c65fdbb661fa"}],"reading":"what the FDA REMS@FDA files tie to the application on the read date; it does not say which prescribers or pharmacies take part or whether a patient needs the program"},"medicaid_state_utilization":{"year":2025,"states_with_data":22,"all_states_medicaid_reimbursed_usd":13184501.6,"all_states_medicaid_paid_prescriptions":3751,"top_states":[{"state":"NY","medicaid_paid_prescriptions":683,"medicaid_reimbursed_usd":2685281.42,"total_reimbursed_usd":2685281.42,"packages":1,"covers":"all_record_types","fact_id":"fdbd4acb3532cbcd8b38e039"},{"state":"IL","medicaid_paid_prescriptions":473,"medicaid_reimbursed_usd":2137184.65,"total_reimbursed_usd":2145798.48,"packages":1,"covers":"fee_for_service_only","fact_id":"86d1905ad0253cdb26af5525"},{"state":"PA","medicaid_paid_prescriptions":309,"medicaid_reimbursed_usd":1296672.33,"total_reimbursed_usd":1296672.33,"packages":1,"covers":"all_record_types","fact_id":"bf964b67f87dd11de882e822"},{"state":"CO","medicaid_paid_prescriptions":198,"medicaid_reimbursed_usd":674002.58,"total_reimbursed_usd":676166.54,"packages":1,"covers":"fee_for_service_only","fact_id":"2c3c088438361d86729f6fd8"},{"state":"ME","medicaid_paid_prescriptions":146,"medicaid_reimbursed_usd":632834.52,"total_reimbursed_usd":657750.24,"packages":2,"covers":"all_record_types","fact_id":"69bc20b96715ebc46d889dbf"},{"state":"MN","medicaid_paid_prescriptions":239,"medicaid_reimbursed_usd":622868.11,"total_reimbursed_usd":622868.11,"packages":3,"covers":"fee_for_service_only","fact_id":"be4ddc0a83e1c7b02f014ebe"},{"state":"NC","medicaid_paid_prescriptions":126,"medicaid_reimbursed_usd":591424.79,"total_reimbursed_usd":600684.81,"packages":1,"covers":"fee_for_service_only","fact_id":"c1a110b2d51593b137c4fc8e"},{"state":"MI","medicaid_paid_prescriptions":139,"medicaid_reimbursed_usd":558043.36,"total_reimbursed_usd":558043.36,"packages":1,"covers":"fee_for_service_only","fact_id":"00d7138fd2b8c38202441b53"},{"state":"MO","medicaid_paid_prescriptions":117,"medicaid_reimbursed_usd":506475.39,"total_reimbursed_usd":506475.39,"packages":1,"covers":"all_record_types","fact_id":"9c7449476b6b9472b12d2690"},{"state":"FL","medicaid_paid_prescriptions":107,"medicaid_reimbursed_usd":419749.18,"total_reimbursed_usd":419749.18,"packages":1,"covers":"fee_for_service_only","fact_id":"fc60d5ddeebc3eec6702398f"}],"unlabelled_state_code_xx":null,"built_from_facts":30,"facts_fee_for_service_only":19,"older_year_facts_not_used":188,"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). 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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:BLA022210","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":"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."}