{"answer":{"query":"Gemtesa","resolved_as":"applications","packages":3,"applications":["NDA213006"],"identity":{"application_numbers":["NDA213006"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2020-12-29","latest":"2020-12-29","packages_with_a_start_date":3}},"generic_entry":[{"application":"NDA213006","date":"2042-07-06","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":"12357636","productNo":"001"},"latest_patent_expiry":"2042-07-06","latest_exclusivity_expiry":"2027-12-18","dated_barriers":6,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":5,"exclusivities_listed":1,"fact_id":"dc0f3afe768093e9b6d08c1f"}],"label_history":{"events_total":2,"non_cmc_events":2,"counts_by_class":{"EFFICACY":1,"LABELING":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA213006","submission_no":11,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-12-18","documents":[{"type":"Label","date":"2024-12-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213006s011lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-12-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213006Orig1s011ltr.pdf","untrusted":true}}],"fact_id":"89bdbcaddf7575d522e60a3e"},{"application":"NDA213006","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-10-08","documents":[{"type":"Letter","date":"2024-12-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213006Orig1s013ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-10-10","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213006s013lbl.pdf","untrusted":true}}],"fact_id":"3bc96c15bb11f5620ff0ee9c"}],"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":"NDA213006","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"GEMTESA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"75MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Vibegron","untrusted":true},"brand":{"text":"Gemtesa","untrusted":true}},"latest_year":2024,"series":[{"year":2021,"gross_spending_usd":28352678.97,"claims":50721,"beneficiaries":19287,"average_spending_per_claim_usd":558.99290176,"fact_id":"d35a49853d3b536e0f660601"},{"year":2022,"gross_spending_usd":164478183.11,"claims":274340,"beneficiaries":70495,"average_spending_per_claim_usd":599.54138336,"fact_id":"6db6beb4581438cf9ea2ae95"},{"year":2023,"gross_spending_usd":508474527.15,"claims":758224,"beneficiaries":187161,"average_spending_per_claim_usd":670.61254609,"fact_id":"a32f651c84f363274e6ce5c0"},{"year":2024,"gross_spending_usd":945088935.3,"claims":1361795,"beneficiaries":320270,"average_spending_per_claim_usd":694.00235373,"fact_id":"6775ac0554c6af68bb074fcd"}],"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":9,"all_states_medicaid_reimbursed_usd":891025.48,"all_states_medicaid_paid_prescriptions":1575,"top_states":[{"state":"MA","medicaid_paid_prescriptions":620,"medicaid_reimbursed_usd":288624.56,"total_reimbursed_usd":302103.36,"packages":1,"covers":"all_record_types","fact_id":"a70040257a05ff90d46446c2"},{"state":"NC","medicaid_paid_prescriptions":213,"medicaid_reimbursed_usd":203358.08,"total_reimbursed_usd":223300.61,"packages":1,"covers":"fee_for_service_only","fact_id":"0c54e962a64e09352baed200"},{"state":"UT","medicaid_paid_prescriptions":183,"medicaid_reimbursed_usd":85509.3,"total_reimbursed_usd":91556.91,"packages":1,"covers":"fee_for_service_only","fact_id":"28e443048585b5c4677b7963"},{"state":"WA","medicaid_paid_prescriptions":122,"medicaid_reimbursed_usd":78869.28,"total_reimbursed_usd":85391.14,"packages":1,"covers":"fee_for_service_only","fact_id":"561a0ee7133b83c06188e73e"},{"state":"VT","medicaid_paid_prescriptions":93,"medicaid_reimbursed_usd":67724.12,"total_reimbursed_usd":67724.12,"packages":1,"covers":"all_record_types","fact_id":"cec114a248fabfef52ebfe02"},{"state":"MN","medicaid_paid_prescriptions":103,"medicaid_reimbursed_usd":57036.05,"total_reimbursed_usd":57036.05,"packages":1,"covers":"fee_for_service_only","fact_id":"9d8ea95f832f61fd32a24daf"},{"state":"CO","medicaid_paid_prescriptions":89,"medicaid_reimbursed_usd":53097.26,"total_reimbursed_usd":57233.24,"packages":1,"covers":"fee_for_service_only","fact_id":"492e19f2b923f10b1ddd035f"},{"state":"NV","medicaid_paid_prescriptions":69,"medicaid_reimbursed_usd":30873.85,"total_reimbursed_usd":30873.85,"packages":1,"covers":"fee_for_service_only","fact_id":"a7abe3eca61e68bda9827387"},{"state":"VA","medicaid_paid_prescriptions":83,"medicaid_reimbursed_usd":25932.98,"total_reimbursed_usd":27510.53,"packages":1,"covers":"all_record_types","fact_id":"6ddfa5d0635646986513d137"}],"unlabelled_state_code_xx":null,"built_from_facts":9,"facts_fee_for_service_only":6,"older_year_facts_not_used":66,"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":"2a2d2b3bd13445ac4db396c2","field":"ndc.listing","entity":"ndc:73336007507"},{"fact_id":"d4f3b324115d818d7b76f69a","field":"ndc.listing","entity":"ndc:73336007530"},{"fact_id":"80d39eeff7b55f9fb847990c","field":"ndc.listing","entity":"ndc:73336007590"},{"fact_id":"dc0f3afe768093e9b6d08c1f","field":"drug.generic_entry_earliest","entity":"application:NDA213006"},{"fact_id":"311443c30412f0374abed267","field":"drug.patent","entity":"application:NDA213006"},{"fact_id":"382398da65e27888a49ae2da","field":"drug.exclusivity","entity":"application:NDA213006"},{"fact_id":"89bdbcaddf7575d522e60a3e","field":"drug.label_event","entity":"application:NDA213006"},{"fact_id":"3bc96c15bb11f5620ff0ee9c","field":"drug.label_event","entity":"application:NDA213006"},{"fact_id":"19dbaf83a1dae557412061aa","field":"drug.marketing_status","entity":"application:NDA213006"},{"fact_id":"d35a49853d3b536e0f660601","field":"drug.partd_spending","entity":"drug:vibegron|gemtesa"},{"fact_id":"6db6beb4581438cf9ea2ae95","field":"drug.partd_spending","entity":"drug:vibegron|gemtesa"},{"fact_id":"a32f651c84f363274e6ce5c0","field":"drug.partd_spending","entity":"drug:vibegron|gemtesa"},{"fact_id":"6775ac0554c6af68bb074fcd","field":"drug.partd_spending","entity":"drug:vibegron|gemtesa"},{"fact_id":"a70040257a05ff90d46446c2","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73336007590:MA"},{"fact_id":"0c54e962a64e09352baed200","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73336007590:NC"},{"fact_id":"28e443048585b5c4677b7963","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73336007530:UT"},{"fact_id":"561a0ee7133b83c06188e73e","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73336007590:WA"},{"fact_id":"cec114a248fabfef52ebfe02","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73336007530:VT"},{"fact_id":"9d8ea95f832f61fd32a24daf","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73336007590:MN"},{"fact_id":"492e19f2b923f10b1ddd035f","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73336007590:CO"},{"fact_id":"a7abe3eca61e68bda9827387","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73336007590:NV"},{"fact_id":"6ddfa5d0635646986513d137","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73336007590: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":"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."}