{"answer":{"query":"Sucraid","resolved_as":"applications","packages":2,"applications":["BLA020772"],"identity":{"application_numbers":["BLA020772"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION","untrusted":true}],"marketing_start":{"earliest":"1998-04-09","latest":"2022-05-25","packages_with_a_start_date":2}},"label_history":{"events_total":15,"non_cmc_events":4,"counts_by_class":{"LABELING":3,"REMS":1},"cmc_events":11,"recent_non_cmc_events":[{"application":"BLA020772","submission_no":31,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-02","documents":[{"type":"Letter","date":"2024-08-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020772Orig1s031ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-08-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020772s031lbl.pdf","untrusted":true}}],"fact_id":"7baaf80cc7fe8d6c7a757319"},{"application":"BLA020772","submission_no":30,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-07-24","documents":[{"type":"Letter","date":"2024-07-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020772Orig1s030ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-07-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020772s030lbl.pdf","untrusted":true}}],"fact_id":"c660ee2a4d263809e7d07a38"},{"application":"BLA020772","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2011-06-15","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020772s008ltr.pdf","untrusted":true}}],"fact_id":"eae8a4556c89d4161c8cfa3e"},{"application":"BLA020772","submission_no":11,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2010-12-09","documents":[{"type":"Letter","date":"2020-03-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020772s011ltr.pdf","untrusted":true}}],"fact_id":"bc4348ce4d2f4fae3d47a6cb"}],"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":"BLA020772","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"SUCRAID","untrusted":true},"form":{"text":"SOLUTION;ORAL","untrusted":true},"strength":{"text":"8,500 IU/ML","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Sacrosidase","untrusted":true},"brand":{"text":"Sucraid","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":37834002.55,"claims":3429,"beneficiaries":798,"average_spending_per_claim_usd":11033.538218,"fact_id":"443fa2af1178a746ed344dae"},{"year":2021,"gross_spending_usd":46624899.14,"claims":4053,"beneficiaries":976,"average_spending_per_claim_usd":11503.799442,"fact_id":"8dccf0281bd0c74a01f69e99"},{"year":2022,"gross_spending_usd":53127582.01,"claims":4551,"beneficiaries":1159,"average_spending_per_claim_usd":11673.825975,"fact_id":"b8543c0bc69072d16ad417ff"},{"year":2023,"gross_spending_usd":77406308.15,"claims":6130,"beneficiaries":1656,"average_spending_per_claim_usd":12627.456468,"fact_id":"e7022f4881ee77abe0b8cb35"},{"year":2024,"gross_spending_usd":107661425.15,"claims":8121,"beneficiaries":2168,"average_spending_per_claim_usd":13257.163545,"fact_id":"e0b8993e0c6e9502d73b55bb"}],"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":"BLA020772","status":"Reference","name":{"text":"Sucraid","untrusted":true},"proper_name":{"text":"sacrosidase","untrusted":true},"license_status":"Licensed","approval_date":"1998-04-09","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":"ad7f594df232ddcfe1654ad5"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"rems":{"programs":[{"application":"BLA020772","program":{"text":"Sucraid","untrusted":true},"rems_id":"267","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":true,"program_date":"2008-11-20","last_modified":"2010-12-09","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=267","other_programs":0,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"8472f0e4c286c2d88a3877c0"}],"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"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"Sacrosidase","untrusted":true},"designation_count":1,"approved_count":1,"recent":[{"designated":"1993-12-10","use":{"text":"Treatment of congenital sucrase-isomaltase deficiency","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"QOL Medical, LLC","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"87e6c05211b0f00047f75b37"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"}},"receipts":[{"fact_id":"02bf7f5e5eba867251a23cd2","field":"ndc.listing","entity":"ndc:67871011104"},{"fact_id":"4e948a751cab18a013c5eb55","field":"ndc.listing","entity":"ndc:67871011107"},{"fact_id":"7baaf80cc7fe8d6c7a757319","field":"drug.label_event","entity":"application:BLA020772"},{"fact_id":"c660ee2a4d263809e7d07a38","field":"drug.label_event","entity":"application:BLA020772"},{"fact_id":"eae8a4556c89d4161c8cfa3e","field":"drug.label_event","entity":"application:BLA020772"},{"fact_id":"bc4348ce4d2f4fae3d47a6cb","field":"drug.label_event","entity":"application:BLA020772"},{"fact_id":"e17576ed39424882bd546f56","field":"drug.marketing_status","entity":"application:BLA020772"},{"fact_id":"443fa2af1178a746ed344dae","field":"drug.partd_spending","entity":"drug:sacrosidase|sucraid"},{"fact_id":"8dccf0281bd0c74a01f69e99","field":"drug.partd_spending","entity":"drug:sacrosidase|sucraid"},{"fact_id":"b8543c0bc69072d16ad417ff","field":"drug.partd_spending","entity":"drug:sacrosidase|sucraid"},{"fact_id":"e7022f4881ee77abe0b8cb35","field":"drug.partd_spending","entity":"drug:sacrosidase|sucraid"},{"fact_id":"e0b8993e0c6e9502d73b55bb","field":"drug.partd_spending","entity":"drug:sacrosidase|sucraid"},{"fact_id":"ad7f594df232ddcfe1654ad5","field":"drug.biologic_status","entity":"application:BLA020772"},{"fact_id":"8472f0e4c286c2d88a3877c0","field":"drug.rems","entity":"application:BLA020772"},{"fact_id":"87e6c05211b0f00047f75b37","field":"drug.orphan_designation","entity":"drug:sacrosidase"}],"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:BLA020772","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":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"},{"code":"NO_DATA","field":"medicaid_state_utilization","reason":"no CMS State Drug Utilization figure for this drug's packages is in the edition (suppressed, out of scope or unreported)"}],"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."}