{"answer":{"query":"Tymlos","resolved_as":"applications","packages":2,"applications":["NDA208743"],"identity":{"application_numbers":["NDA208743"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2017-05-01","latest":"2017-05-01","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA208743","date":"2040-01-10","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled)","driver":{"kind":"patent","ref":"11255842","productNo":"001"},"latest_patent_expiry":"2040-01-10","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":9,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":9,"exclusivities_listed":0,"fact_id":"ad15a5fcd7926099f8d20b7c"}],"label_history":{"events_total":10,"non_cmc_events":10,"counts_by_class":{"LABELING":6,"EFFICACY":4},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA208743","submission_no":18,"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/2026/208743Orig1s018ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-08-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208743s018lbl.pdf","untrusted":true}}],"fact_id":"13d7f7a005118aeb9f60c004"},{"application":"NDA208743","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-28","documents":[{"type":"Letter","date":"2025-04-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208743Orig1s017ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-03-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208743s017lbl.pdf","untrusted":true}}],"fact_id":"143553290d3a6dbe7dd60d64"},{"application":"NDA208743","submission_no":15,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-12-21","documents":[{"type":"Letter","date":"2023-12-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208743Orig1s015ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-12-27","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208743Orig1s015lbl.pdf","untrusted":true}}],"fact_id":"877b63e96087afdceaeae431"},{"application":"NDA208743","submission_no":13,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-12-19","documents":[{"type":"Label","date":"2022-12-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208743s013lbl.pdf","untrusted":true}}],"fact_id":"58f9804da8be37c96a6b1118"},{"application":"NDA208743","submission_no":10,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-12-22","documents":[{"type":"Label","date":"2021-12-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208743s010lbl.pdf","untrusted":true}}],"fact_id":"03a613db6064797e30206e1b"}],"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":"NDA208743","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"TYMLOS","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"3.12MG/1.56ML (2MG/ML)","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Abaloparatide","untrusted":true},"brand":{"text":"Tymlos","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":132756710,"claims":60036,"beneficiaries":11704,"average_spending_per_claim_usd":2211.2850623,"fact_id":"febd892c58a11625cf5d964e"},{"year":2021,"gross_spending_usd":137835466.38,"claims":58817,"beneficiaries":11638,"average_spending_per_claim_usd":2343.4630529,"fact_id":"8cd99f8b5d1a41416e2ad16b"},{"year":2022,"gross_spending_usd":156712783.57,"claims":60207,"beneficiaries":11168,"average_spending_per_claim_usd":2602.8997221,"fact_id":"ba50ec039c934daa123d4fe3"},{"year":2023,"gross_spending_usd":197623448.36,"claims":69151,"beneficiaries":12979,"average_spending_per_claim_usd":2857.8538034,"fact_id":"455f6d29b060806f8e7a3296"},{"year":2024,"gross_spending_usd":257643485.05,"claims":88564,"beneficiaries":16530,"average_spending_per_claim_usd":2909.1220479,"fact_id":"53bac968935fec8637229331"}],"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}}},"medicaid_state_utilization":{"year":2025,"states_with_data":4,"all_states_medicaid_reimbursed_usd":711558.86,"all_states_medicaid_paid_prescriptions":248,"top_states":[{"state":"CT","medicaid_paid_prescriptions":76,"medicaid_reimbursed_usd":226585.46,"total_reimbursed_usd":226585.46,"packages":1,"covers":"all_record_types","fact_id":"9f0af33bd180cb1e37a8c766"},{"state":"UT","medicaid_paid_prescriptions":64,"medicaid_reimbursed_usd":200367.73,"total_reimbursed_usd":200367.73,"packages":1,"covers":"fee_for_service_only","fact_id":"76c17e37057e3bfad285685a"},{"state":"IA","medicaid_paid_prescriptions":56,"medicaid_reimbursed_usd":155512.01,"total_reimbursed_usd":155512.01,"packages":1,"covers":"all_record_types","fact_id":"75c9351b26716380b2fde61a"},{"state":"MA","medicaid_paid_prescriptions":52,"medicaid_reimbursed_usd":129093.66,"total_reimbursed_usd":129093.66,"packages":1,"covers":"fee_for_service_only","fact_id":"b9296e518a7d4d04937725d4"}],"unlabelled_state_code_xx":null,"built_from_facts":4,"facts_fee_for_service_only":2,"older_year_facts_not_used":23,"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":"05b74699964de39c65bc8e2e","field":"ndc.listing","entity":"ndc:70539000102"},{"fact_id":"1767a312d866a841c734804b","field":"ndc.listing","entity":"ndc:70539000198"},{"fact_id":"ad15a5fcd7926099f8d20b7c","field":"drug.generic_entry_earliest","entity":"application:NDA208743"},{"fact_id":"507389e12d95c3946046b329","field":"drug.patent","entity":"application:NDA208743"},{"fact_id":"13d7f7a005118aeb9f60c004","field":"drug.label_event","entity":"application:NDA208743"},{"fact_id":"143553290d3a6dbe7dd60d64","field":"drug.label_event","entity":"application:NDA208743"},{"fact_id":"877b63e96087afdceaeae431","field":"drug.label_event","entity":"application:NDA208743"},{"fact_id":"58f9804da8be37c96a6b1118","field":"drug.label_event","entity":"application:NDA208743"},{"fact_id":"03a613db6064797e30206e1b","field":"drug.label_event","entity":"application:NDA208743"},{"fact_id":"3566696b13562c02352d46f8","field":"drug.marketing_status","entity":"application:NDA208743"},{"fact_id":"febd892c58a11625cf5d964e","field":"drug.partd_spending","entity":"drug:abaloparatide|tymlos"},{"fact_id":"8cd99f8b5d1a41416e2ad16b","field":"drug.partd_spending","entity":"drug:abaloparatide|tymlos"},{"fact_id":"ba50ec039c934daa123d4fe3","field":"drug.partd_spending","entity":"drug:abaloparatide|tymlos"},{"fact_id":"455f6d29b060806f8e7a3296","field":"drug.partd_spending","entity":"drug:abaloparatide|tymlos"},{"fact_id":"53bac968935fec8637229331","field":"drug.partd_spending","entity":"drug:abaloparatide|tymlos"},{"fact_id":"9f0af33bd180cb1e37a8c766","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70539000102:CT"},{"fact_id":"76c17e37057e3bfad285685a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70539000102:UT"},{"fact_id":"75c9351b26716380b2fde61a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70539000102:IA"},{"fact_id":"b9296e518a7d4d04937725d4","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70539000102:MA"}],"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":"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":"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":"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."}