{"answer":{"query":"Forteo","resolved_as":"applications","packages":4,"applications":["NDA021318"],"identity":{"application_numbers":["NDA021318"],"marketing_categories":["NDA","NDA AUTHORIZED GENERIC"],"labelers":[{"text":"ELI LILLY AND COMPANY","untrusted":true}],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2008-10-01","latest":"2025-06-16","packages_with_a_start_date":4}},"label_history":{"events_total":25,"non_cmc_events":15,"counts_by_class":{"LABELING":11,"EFFICACY":2,"REMS":2},"cmc_events":10,"recent_non_cmc_events":[{"application":"NDA021318","submission_no":59,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-08-03","documents":[{"type":"Letter","date":"2026-08-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021318Orig1s059ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-08-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021318Orig1s059lbl.pdf","untrusted":true}}],"fact_id":"7498b98581a3ee787bf285fe"},{"application":"NDA021318","submission_no":57,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-07-24","documents":[{"type":"Label","date":"2024-07-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021318s057lbl.pdf","untrusted":true}}],"fact_id":"d44b220da6aa15e506c1ad37"},{"application":"NDA021318","submission_no":56,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-09-07","documents":[{"type":"Letter","date":"2021-09-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021318Orig1s056ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-09-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021318Orig1s056lbl.pdf","untrusted":true}}],"fact_id":"179e5fc44e3ee91452efbd80"},{"application":"NDA021318","submission_no":54,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2020-11-16","documents":[{"type":"Letter","date":"2020-12-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021318Orig1s054ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-12-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318Orig1s054lbl.pdf","untrusted":true}}],"fact_id":"18284989a418c61776a19deb"},{"application":"NDA021318","submission_no":53,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-04-06","documents":[{"type":"Letter","date":"2020-04-07","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021318Orig1s053ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-04-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021318s053lbl.pdf","untrusted":true}}],"fact_id":"e0399e982e1e91911e80751a"}],"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":{"AP":1,"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":1,"Discontinued":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":"NDA021318","product_no":"002","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"FORTEO","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"0.56MG/2.24ML (0.25MG/ML)","untrusted":true}},{"application":"NDA021318","product_no":"001","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"FORTEO","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"0.75MG/3ML (0.25MG/ML)","untrusted":true}}]},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":1,"next_package_termination_dates":[],"packages_with_future_termination_date":0,"termination_meaning":"manufacturer-reported last-lot expiry or withdrawal date of one package; other packages and generics can remain"},"spending":{"reported_under":{"generic":{"text":"Teriparatide","untrusted":true},"brand":{"text":"Forteo","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":457345879.93,"claims":113852,"beneficiaries":19160,"average_spending_per_claim_usd":4017.0210443,"fact_id":"d2726a9e5c51f5a2182737d9"},{"year":2021,"gross_spending_usd":371324573.67,"claims":90142,"beneficiaries":15671,"average_spending_per_claim_usd":4119.3292102,"fact_id":"b464633558134f2c6bdfbebb"},{"year":2022,"gross_spending_usd":368538666.72,"claims":87421,"beneficiaries":14551,"average_spending_per_claim_usd":4215.6766306,"fact_id":"230ce92174853c7630f541ef"},{"year":2023,"gross_spending_usd":425012974.57,"claims":97244,"beneficiaries":15602,"average_spending_per_claim_usd":4370.5830136,"fact_id":"954a612e173d9e8a590876a8"},{"year":2024,"gross_spending_usd":266352817.64,"claims":67653,"beneficiaries":11433,"average_spending_per_claim_usd":3937.043703,"fact_id":"d0654dc629ab0d387af0e575"}],"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}}},"rems":{"programs":[{"application":"NDA021318","program":{"text":"Forteo","untrusted":true},"rems_id":"19","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":false,"program_date":"2009-07-22","last_modified":"2017-04-28","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=19","other_programs":0,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"0d6ce51d50dab0c0a62d1b17"}],"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":"Teriparatide; teriparatide","untrusted":true},"designation_count":3,"approved_count":1,"recent":[{"designated":"2014-04-18","use":{"text":"Treatment of hypoparathyroidism","untrusted":true},"status":"Designated","sponsor":{"text":"Entera Bio, Ltd.","untrusted":true},"approved":false},{"designated":"1999-10-28","use":{"text":"Treatment of idiopathic osteoporosis.","untrusted":true},"status":"Designated","sponsor":{"text":"Biomeasure, Inc.","untrusted":true},"approved":false},{"designated":"1987-01-09","use":{"text":"Diagnostic agent to assist in establishing the diagnosis in patients presenting with clinical and laboratory evidence of hypocalcemia due to either hypoparathyroidism or pseudohypoparathyroidism.","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Rhone-Poulenc Rorer Pharmaceuticals, Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"67a5c08aac9e552b877c0d90"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":4,"all_states_medicaid_reimbursed_usd":1129987.24,"all_states_medicaid_paid_prescriptions":426,"top_states":[{"state":"CO","medicaid_paid_prescriptions":153,"medicaid_reimbursed_usd":672974.1,"total_reimbursed_usd":672974.1,"packages":1,"covers":"all_record_types","fact_id":"f4f23a527935e0584cf19207"},{"state":"PR","medicaid_paid_prescriptions":116,"medicaid_reimbursed_usd":220808.87,"total_reimbursed_usd":229450.29,"packages":1,"covers":"all_record_types","fact_id":"3099b9335ee1ce8baacea3fe"},{"state":"NC","medicaid_paid_prescriptions":65,"medicaid_reimbursed_usd":138197.99,"total_reimbursed_usd":138197.99,"packages":1,"covers":"fee_for_service_only","fact_id":"482a4c8975ef1ec328f68b99"},{"state":"VA","medicaid_paid_prescriptions":92,"medicaid_reimbursed_usd":98006.28,"total_reimbursed_usd":100056.25,"packages":1,"covers":"fee_for_service_only","fact_id":"5b201dcee3f0a2b4ee3cbaf0"}],"unlabelled_state_code_xx":null,"built_from_facts":4,"facts_fee_for_service_only":2,"older_year_facts_not_used":29,"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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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":"9635634c4ce2039a2a226d3a","field":"ndc.listing","entity":"ndc:00002840001"},{"fact_id":"a71eb79acd5ab56dc117e785","field":"ndc.listing","entity":"ndc:00002967801"},{"fact_id":"a8bc961193a1bab21ecc8726","field":"ndc.listing","entity":"ndc:66993049528"},{"fact_id":"7498b98581a3ee787bf285fe","field":"drug.label_event","entity":"application:NDA021318"},{"fact_id":"d44b220da6aa15e506c1ad37","field":"drug.label_event","entity":"application:NDA021318"},{"fact_id":"179e5fc44e3ee91452efbd80","field":"drug.label_event","entity":"application:NDA021318"},{"fact_id":"18284989a418c61776a19deb","field":"drug.label_event","entity":"application:NDA021318"},{"fact_id":"e0399e982e1e91911e80751a","field":"drug.label_event","entity":"application:NDA021318"},{"fact_id":"9f8d5c0a203926735c3d489c","field":"drug.te_code","entity":"application:NDA021318"},{"fact_id":"7e61be25a956fda9907c6695","field":"drug.marketing_status","entity":"application:NDA021318"},{"fact_id":"f554785d67452748afe65992","field":"drug.marketing_status","entity":"application:NDA021318"},{"fact_id":"d2726a9e5c51f5a2182737d9","field":"drug.partd_spending","entity":"drug:teriparatide|forteo"},{"fact_id":"b464633558134f2c6bdfbebb","field":"drug.partd_spending","entity":"drug:teriparatide|forteo"},{"fact_id":"230ce92174853c7630f541ef","field":"drug.partd_spending","entity":"drug:teriparatide|forteo"},{"fact_id":"954a612e173d9e8a590876a8","field":"drug.partd_spending","entity":"drug:teriparatide|forteo"},{"fact_id":"d0654dc629ab0d387af0e575","field":"drug.partd_spending","entity":"drug:teriparatide|forteo"},{"fact_id":"0d6ce51d50dab0c0a62d1b17","field":"drug.rems","entity":"application:NDA021318"},{"fact_id":"67a5c08aac9e552b877c0d90","field":"drug.orphan_designation","entity":"drug:teriparatide"},{"fact_id":"f4f23a527935e0584cf19207","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00002840001:CO"},{"fact_id":"3099b9335ee1ce8baacea3fe","field":"ndc.medicaid_state_utilization","entity":"ndc_state:66993049528:PR"},{"fact_id":"482a4c8975ef1ec328f68b99","field":"ndc.medicaid_state_utilization","entity":"ndc_state:66993049528:NC"},{"fact_id":"5b201dcee3f0a2b4ee3cbaf0","field":"ndc.medicaid_state_utilization","entity":"ndc_state:66993049528:VA"}],"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:NDA021318","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":"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":"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"}],"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."}