{"answer":{"query":"Teriparatide","resolved_as":"applications","packages":10,"applications":["ANDA208569","ANDA211097","ANDA213641","NDA021318","NDA211939"],"identity":{"application_numbers":["ANDA208569","ANDA211097","ANDA213641","NDA021318","NDA211939"],"marketing_categories":["NDA","ANDA","NDA AUTHORIZED GENERIC"],"labelers":[{"text":"ELI LILLY AND COMPANY","untrusted":true}],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true},{"text":"INJECTION","untrusted":true}],"marketing_start":{"earliest":"2008-10-01","latest":"2026-03-19","packages_with_a_start_date":10}},"label_history":{"events_total":30,"non_cmc_events":20,"counts_by_class":{"LABELING":15,"EFFICACY":3,"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":"NDA211939","submission_no":21,"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/2026/211939Orig1s021ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-08-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/211939s021lbl.pdf","untrusted":true}}],"fact_id":"be7994f90db779bca92f7211"},{"application":"NDA211939","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-24","documents":[{"type":"Label","date":"2025-02-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211939Orig1s017lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211939Orig1s017ltr.pdf","untrusted":true}}],"fact_id":"f28cab24a9792cf53431a1fc"},{"application":"ANDA211097","submission_no":1,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-11-07","documents":[],"fact_id":"b89a5a83d5001a796959cdd0"},{"application":"ANDA208569","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-11-06","documents":[],"fact_id":"936d04ce8a3dc32e092ced00"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":6,"te_code_counts":{"AP":4,"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":5,"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":"ANDA208569","product_no":"001","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"TERIPARATIDE","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"0.56MG/2.24ML (0.25MG/ML)","untrusted":true}},{"application":"ANDA211097","product_no":"001","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"TERIPARATIDE","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"0.56MG/2.24ML (0.25MG/ML)","untrusted":true}},{"application":"ANDA213641","product_no":"001","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"TERIPARATIDE","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"0.56MG/2.24ML (0.25MG/ML)","untrusted":true}},{"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}},{"application":"NDA211939","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"BONSITY","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"0.56MG/2.24ML (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":"Teriparatide","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":956570.3,"claims":334,"beneficiaries":138,"average_spending_per_claim_usd":2863.9829341,"fact_id":"5ae9c147ef1a0d5bdc894a23"},{"year":2021,"gross_spending_usd":24618812.87,"claims":8478,"beneficiaries":2408,"average_spending_per_claim_usd":2903.8467646,"fact_id":"2079e27d002992175621e5b9"},{"year":2022,"gross_spending_usd":62447672.57,"claims":21705,"beneficiaries":3949,"average_spending_per_claim_usd":2877.1100009,"fact_id":"405a60f231145ce9cfb2b32f"},{"year":2023,"gross_spending_usd":89084656.19,"claims":30242,"beneficiaries":7021,"average_spending_per_claim_usd":2945.7263471,"fact_id":"5bfe23fa7c3b9ecf4e1bc794"},{"year":2024,"gross_spending_usd":212620906.39,"claims":81093,"beneficiaries":15831,"average_spending_per_claim_usd":2621.9390871,"fact_id":"b337119939eb5c3e9d93c175"}],"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":9,"all_states_medicaid_reimbursed_usd":3107937.98,"all_states_medicaid_paid_prescriptions":1457,"top_states":[{"state":"PA","medicaid_paid_prescriptions":478,"medicaid_reimbursed_usd":1045808.12,"total_reimbursed_usd":1053200.51,"packages":2,"covers":"all_record_types","fact_id":"88dc8e1f92ffb4f3a6bd12ae"},{"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":"LA","medicaid_paid_prescriptions":112,"medicaid_reimbursed_usd":281092.16,"total_reimbursed_usd":282005.75,"packages":1,"covers":"all_record_types","fact_id":"9dca6be6ba0efdfedcc996e6"},{"state":"NY","medicaid_paid_prescriptions":177,"medicaid_reimbursed_usd":272245.8,"total_reimbursed_usd":275645.22,"packages":1,"covers":"fee_for_service_only","fact_id":"a681f40a1235171de5986996"},{"state":"WA","medicaid_paid_prescriptions":150,"medicaid_reimbursed_usd":229859.16,"total_reimbursed_usd":229859.16,"packages":1,"covers":"all_record_types","fact_id":"99f74d1b95ed30819797a5b5"},{"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":"NJ","medicaid_paid_prescriptions":114,"medicaid_reimbursed_usd":148945.5,"total_reimbursed_usd":148945.5,"packages":1,"covers":"all_record_types","fact_id":"24a70cbfc16e1c87984a24e8"},{"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":10,"facts_fee_for_service_only":3,"older_year_facts_not_used":45,"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:ANDA208569","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:ANDA211097","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:ANDA213641","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: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:NDA211939","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":"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."}