{"answer":{"query":"Ubrelvy","resolved_as":"applications","packages":17,"applications":["NDA211765"],"identity":{"application_numbers":["NDA211765"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2019-12-23","latest":"2026-09-29","packages_with_a_start_date":17}},"generic_entry":[{"application":"NDA211765","date":"2041-12-22","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":"11717515","productNo":"001"},"latest_patent_expiry":"2041-12-22","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":27,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":16,"exclusivities_listed":0,"fact_id":"0babfc3e459f08bc4bba637c"}],"label_history":{"events_total":4,"non_cmc_events":4,"counts_by_class":{"LABELING":4},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA211765","submission_no":12,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-05","documents":[{"type":"Letter","date":"2025-06-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211765Orig1s012ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-06-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211765s012lbl.pdf","untrusted":true}}],"fact_id":"7de33407437c7d9772b318ab"},{"application":"NDA211765","submission_no":13,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-21","documents":[{"type":"Label","date":"2025-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/211765s013lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/211765Orig1s013ltr.pdf","untrusted":true}}],"fact_id":"1bd9ba1f153e070cc50d1c1b"},{"application":"NDA211765","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-02-17","documents":[{"type":"Letter","date":"2023-02-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/211765Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-02-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/211765s007lbl.pdf","untrusted":true}}],"fact_id":"770951ccd9edcbc67fdb9c05"},{"application":"NDA211765","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-03-03","documents":[{"type":"Letter","date":"2021-03-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/211765Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"79f0f74592fdfd5acf408814"}],"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":{"NOT_PROVIDED":2},"marketing_status_counts":{"Prescription":2},"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":"NDA211765","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"UBRELVY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}},{"application":"NDA211765","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"UBRELVY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"100MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Ubrogepant","untrusted":true},"brand":{"text":"Ubrelvy","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":46916765.43,"claims":46590,"beneficiaries":16345,"average_spending_per_claim_usd":1007.0136388,"fact_id":"cca23b6cbb1eba4e690e4318"},{"year":2021,"gross_spending_usd":132378259.89,"claims":121560,"beneficiaries":33871,"average_spending_per_claim_usd":1088.9952278,"fact_id":"76dd4b1cdd0b3ebcd8fe5aa2"},{"year":2022,"gross_spending_usd":232438289.53,"claims":189716,"beneficiaries":48669,"average_spending_per_claim_usd":1225.1907563,"fact_id":"74109a0fc96f08892890d2a2"},{"year":2023,"gross_spending_usd":314665015.55,"claims":235391,"beneficiaries":58411,"average_spending_per_claim_usd":1336.7758986,"fact_id":"8f3cc012c9d6352e7c999da3"},{"year":2024,"gross_spending_usd":429537897.96,"claims":328213,"beneficiaries":83437,"average_spending_per_claim_usd":1308.7168941,"fact_id":"79586fb05a03ea35940668e8"}],"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":5,"all_states_medicaid_reimbursed_usd":1856169.64,"all_states_medicaid_paid_prescriptions":1362,"top_states":[{"state":"WA","medicaid_paid_prescriptions":834,"medicaid_reimbursed_usd":1176782.95,"total_reimbursed_usd":1187047.37,"packages":1,"covers":"fee_for_service_only","fact_id":"709efc10661228744525f7fe"},{"state":"OK","medicaid_paid_prescriptions":207,"medicaid_reimbursed_usd":297908.78,"total_reimbursed_usd":304421.25,"packages":2,"covers":"fee_for_service_only","fact_id":"8bca68fe5b452c9bd4fe4760"},{"state":"PR","medicaid_paid_prescriptions":140,"medicaid_reimbursed_usd":157777.13,"total_reimbursed_usd":157777.13,"packages":1,"covers":"all_record_types","fact_id":"9e7eb8ae3b862a070a60c807"},{"state":"MT","medicaid_paid_prescriptions":104,"medicaid_reimbursed_usd":154976.67,"total_reimbursed_usd":154976.67,"packages":1,"covers":"all_record_types","fact_id":"a61d6d6d1dc291de4a013ff9"},{"state":"MO","medicaid_paid_prescriptions":77,"medicaid_reimbursed_usd":68724.11,"total_reimbursed_usd":71111.29,"packages":1,"covers":"all_record_types","fact_id":"f124d1d9e463f44beab44467"}],"unlabelled_state_code_xx":null,"built_from_facts":6,"facts_fee_for_service_only":3,"older_year_facts_not_used":130,"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":"404534139db9520912650015","field":"ndc.listing","entity":"ndc:00023649801"},{"fact_id":"371cc456bccd50ee60db98b1","field":"ndc.listing","entity":"ndc:00023649804"},{"fact_id":"83be9c783d37291661d50cef","field":"ndc.listing","entity":"ndc:00023649810"},{"fact_id":"0babfc3e459f08bc4bba637c","field":"drug.generic_entry_earliest","entity":"application:NDA211765"},{"fact_id":"f85dcdef2ea2d4347fb4aae9","field":"drug.patent","entity":"application:NDA211765"},{"fact_id":"7de33407437c7d9772b318ab","field":"drug.label_event","entity":"application:NDA211765"},{"fact_id":"1bd9ba1f153e070cc50d1c1b","field":"drug.label_event","entity":"application:NDA211765"},{"fact_id":"770951ccd9edcbc67fdb9c05","field":"drug.label_event","entity":"application:NDA211765"},{"fact_id":"79f0f74592fdfd5acf408814","field":"drug.label_event","entity":"application:NDA211765"},{"fact_id":"af839270088038578177f537","field":"drug.marketing_status","entity":"application:NDA211765"},{"fact_id":"88d97cfff1e077e273f97258","field":"drug.marketing_status","entity":"application:NDA211765"},{"fact_id":"cca23b6cbb1eba4e690e4318","field":"drug.partd_spending","entity":"drug:ubrogepant|ubrelvy"},{"fact_id":"76dd4b1cdd0b3ebcd8fe5aa2","field":"drug.partd_spending","entity":"drug:ubrogepant|ubrelvy"},{"fact_id":"74109a0fc96f08892890d2a2","field":"drug.partd_spending","entity":"drug:ubrogepant|ubrelvy"},{"fact_id":"8f3cc012c9d6352e7c999da3","field":"drug.partd_spending","entity":"drug:ubrogepant|ubrelvy"},{"fact_id":"79586fb05a03ea35940668e8","field":"drug.partd_spending","entity":"drug:ubrogepant|ubrelvy"},{"fact_id":"709efc10661228744525f7fe","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023650116:WA"},{"fact_id":"8bca68fe5b452c9bd4fe4760","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023650116:OK"},{"fact_id":"9e7eb8ae3b862a070a60c807","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023650110:PR"},{"fact_id":"a61d6d6d1dc291de4a013ff9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023650116:MT"},{"fact_id":"f124d1d9e463f44beab44467","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00023650116:MO"}],"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."}