{"answer":{"query":"Strensiq","resolved_as":"applications","packages":4,"applications":["BLA125513"],"identity":{"application_numbers":["BLA125513"],"marketing_categories":["BLA"],"labelers":[],"dosage_forms":[{"text":"SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2015-10-23","latest":"2015-10-23","packages_with_a_start_date":4}},"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"LABELING":3,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"BLA125513","submission_no":33,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-07-10","documents":[{"type":"Letter","date":"2024-07-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125513Orig1s033ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-07-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125513s033lbl.pdf","untrusted":true}}],"fact_id":"163ec054e9936d6d9029fc2e"},{"application":"BLA125513","submission_no":18,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2020-06-12","documents":[{"type":"Label","date":"2020-06-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125513s018lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-06-16","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125513Orig1s018ltr.pdf","untrusted":true}}],"fact_id":"df94672dd6d0d9d71681e87f"},{"application":"BLA125513","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-01-26","documents":[{"type":"Label","date":"2018-01-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125513s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-01-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125513Orig1s003ltr.pdf","untrusted":true}}],"fact_id":"a4e49d1d878956c5802ede4c"},{"application":"BLA125513","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-10-18","documents":[{"type":"Letter","date":"2016-10-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125513Orig1s002ltr.pdf","untrusted":true}},{"type":"Label","date":"2017-02-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125513s002lbl.pdf","untrusted":true}}],"fact_id":"602b7a41595dd4ec2aa64474"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":4,"te_code_counts":{"NOT_PROVIDED":4},"marketing_status_counts":{"Prescription":4},"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":"BLA125513","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"STRENSIQ","untrusted":true},"form":{"text":"SOLUTION;INJECTION","untrusted":true},"strength":{"text":"18MG/0.45ML","untrusted":true}},{"application":"BLA125513","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"STRENSIQ","untrusted":true},"form":{"text":"SOLUTION;INJECTION","untrusted":true},"strength":{"text":"28MG/0.7ML","untrusted":true}},{"application":"BLA125513","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"STRENSIQ","untrusted":true},"form":{"text":"SOLUTION;INJECTION","untrusted":true},"strength":{"text":"80MG/0.8ML","untrusted":true}},{"application":"BLA125513","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"STRENSIQ","untrusted":true},"form":{"text":"SOLUTION;INJECTION","untrusted":true},"strength":{"text":"40MG/ML","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Asfotase Alfa","untrusted":true},"brand":{"text":"Strensiq","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":139626523.03,"claims":1404,"beneficiaries":103,"average_spending_per_claim_usd":99449.090477,"fact_id":"29f2be3acfe3726d1ec86c29"},{"year":2021,"gross_spending_usd":179636997.61,"claims":1758,"beneficiaries":126,"average_spending_per_claim_usd":102182.5925,"fact_id":"840bc4ea53393cd150dd746b"},{"year":2022,"gross_spending_usd":220781958.21,"claims":2155,"beneficiaries":167,"average_spending_per_claim_usd":102451.02469,"fact_id":"9606c544badf1f3a0d530d79"},{"year":2023,"gross_spending_usd":258940106.05,"claims":2533,"beneficiaries":207,"average_spending_per_claim_usd":102226.65063,"fact_id":"d7cacdbe58c6ce056674ea12"},{"year":2024,"gross_spending_usd":345971143.7,"claims":3431,"beneficiaries":290,"average_spending_per_claim_usd":100836.82416,"fact_id":"d7edc5612f7716e606b7f7b1"}],"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":"BLA125513","status":"Reference","name":{"text":"Strensiq","untrusted":true},"proper_name":{"text":"asfotase alfa","untrusted":true},"license_status":"Licensed","approval_date":"2015-10-23","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":"d5cf82ca9da6e50cdb0fc277"}],"reading":"what the FDA Purple Book lists on its read date, a record and not a forecast of launch or substitution"},"medicaid_state_utilization":{"year":2025,"states_with_data":4,"all_states_medicaid_reimbursed_usd":15270131.61,"all_states_medicaid_paid_prescriptions":242,"top_states":[{"state":"TX","medicaid_paid_prescriptions":72,"medicaid_reimbursed_usd":8266600.63,"total_reimbursed_usd":8401214.4,"packages":1,"covers":"all_record_types","fact_id":"f2ab22aa9d29633ffec7dc38"},{"state":"WI","medicaid_paid_prescriptions":65,"medicaid_reimbursed_usd":3178822.43,"total_reimbursed_usd":3283544.75,"packages":1,"covers":"all_record_types","fact_id":"f2336eb180fb8e4c73076eda"},{"state":"NJ","medicaid_paid_prescriptions":54,"medicaid_reimbursed_usd":2649115.49,"total_reimbursed_usd":2649115.49,"packages":1,"covers":"all_record_types","fact_id":"360fac892d85d95b0e87e552"},{"state":"PA","medicaid_paid_prescriptions":51,"medicaid_reimbursed_usd":1175593.06,"total_reimbursed_usd":1439156.26,"packages":1,"covers":"all_record_types","fact_id":"0d1e2a5ac5c8264ed5d1b6cc"}],"unlabelled_state_code_xx":null,"built_from_facts":4,"facts_fee_for_service_only":0,"older_year_facts_not_used":13,"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":"e321e195d00a592587273606","field":"ndc.listing","entity":"ndc:25682001012"},{"fact_id":"6895afb527009baa667ac515","field":"ndc.listing","entity":"ndc:25682001312"},{"fact_id":"329a126bed782b0d3f3bd475","field":"ndc.listing","entity":"ndc:25682001612"},{"fact_id":"163ec054e9936d6d9029fc2e","field":"drug.label_event","entity":"application:BLA125513"},{"fact_id":"df94672dd6d0d9d71681e87f","field":"drug.label_event","entity":"application:BLA125513"},{"fact_id":"a4e49d1d878956c5802ede4c","field":"drug.label_event","entity":"application:BLA125513"},{"fact_id":"602b7a41595dd4ec2aa64474","field":"drug.label_event","entity":"application:BLA125513"},{"fact_id":"e06e43beae278a98b5a654fc","field":"drug.marketing_status","entity":"application:BLA125513"},{"fact_id":"8584d5834fe2a79e63174f2f","field":"drug.marketing_status","entity":"application:BLA125513"},{"fact_id":"5a67d46e545dbfaf15d08520","field":"drug.marketing_status","entity":"application:BLA125513"},{"fact_id":"567a27b10f31e137c5686d55","field":"drug.marketing_status","entity":"application:BLA125513"},{"fact_id":"29f2be3acfe3726d1ec86c29","field":"drug.partd_spending","entity":"drug:asfotase-alfa|strensiq"},{"fact_id":"840bc4ea53393cd150dd746b","field":"drug.partd_spending","entity":"drug:asfotase-alfa|strensiq"},{"fact_id":"9606c544badf1f3a0d530d79","field":"drug.partd_spending","entity":"drug:asfotase-alfa|strensiq"},{"fact_id":"d7cacdbe58c6ce056674ea12","field":"drug.partd_spending","entity":"drug:asfotase-alfa|strensiq"},{"fact_id":"d7edc5612f7716e606b7f7b1","field":"drug.partd_spending","entity":"drug:asfotase-alfa|strensiq"},{"fact_id":"d5cf82ca9da6e50cdb0fc277","field":"drug.biologic_status","entity":"application:BLA125513"},{"fact_id":"f2ab22aa9d29633ffec7dc38","field":"ndc.medicaid_state_utilization","entity":"ndc_state:25682001912:TX"},{"fact_id":"f2336eb180fb8e4c73076eda","field":"ndc.medicaid_state_utilization","entity":"ndc_state:25682001612:WI"},{"fact_id":"360fac892d85d95b0e87e552","field":"ndc.medicaid_state_utilization","entity":"ndc_state:25682001612:NJ"},{"fact_id":"0d1e2a5ac5c8264ed5d1b6cc","field":"ndc.medicaid_state_utilization","entity":"ndc_state:25682001312:PA"}],"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:BLA125513","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":"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."}