{"answer":{"query":"verzenio","resolved_as":"name","packages":5,"applications":["NDA208716"],"identity":{"application_numbers":["NDA208716"],"marketing_categories":["NDA"],"labelers":[{"text":"ELI LILLY AND COMPANY","untrusted":true}],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2017-10-06","latest":"2025-02-15","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA208716","date":"2031-09-28","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":"7855211","productNo":"002"},"latest_patent_expiry":"2031-09-28","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":4,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":0,"fact_id":"67cc878ef5f45655aa939511"}],"label_history":{"events_total":12,"non_cmc_events":12,"counts_by_class":{"EFFICACY":9,"LABELING":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA208716","submission_no":22,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-09-18","documents":[{"type":"Label","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208716s022lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-09-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208716Orig1s022ltr.pdf","untrusted":true}}],"fact_id":"b354a8d59cbf80641e1e996f"},{"application":"NDA208716","submission_no":21,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-07-13","documents":[{"type":"Label","date":"2026-07-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208716s021lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-07-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/208716Orig1s021ltr.pdf","untrusted":true}}],"fact_id":"02c0b2f07d0099e5ad975b43"},{"application":"NDA208716","submission_no":19,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-02-27","documents":[{"type":"Letter","date":"2025-02-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208716Orig1s019ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-03-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208716s019lbl.pdf","untrusted":true}}],"fact_id":"459fa2f5de3f8755bf3e8a1f"},{"application":"NDA208716","submission_no":17,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-11-13","documents":[{"type":"Label","date":"2024-11-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/208716s017lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-11-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208716Orig1s017ltr.pdf","untrusted":true}}],"fact_id":"9178c4445d8e7336c8d07848"},{"application":"NDA208716","submission_no":11,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-03-03","documents":[{"type":"Label","date":"2023-03-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-03-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208716Orig1s010,s011ltr.pdf","untrusted":true}}],"fact_id":"810407a68208ec72bdc0d7b6"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":4,"te_code_counts":{"NOT_PROVIDED":4},"marketing_status_counts":{"Prescription":4},"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":"NDA208716","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"VERZENIO","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}},{"application":"NDA208716","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"VERZENIO","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"200MG","untrusted":true}},{"application":"NDA208716","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"VERZENIO","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"150MG","untrusted":true}},{"application":"NDA208716","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"VERZENIO","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"100MG","untrusted":true}}]},"trials":{"attribution":"Source: ClinicalTrials.gov","modification_statement":"OmniRx has summarized and trimmed this ClinicalTrials.gov data.","not_an_offer":"A recruiting trial listing is not an offer of free drug and not medical advice; enrollment is decided by the study team.","ingredients":[{"ingredient":{"text":"ABEMACICLIB","untrusted":true},"recruiting_interventional_count":88,"not_yet_recruiting_count":16,"by_phase":{"PHASE4":2,"PHASE1/PHASE2":22,"NA":7,"PHASE1":10,"PHASE3":8,"PHASE2":37,"EARLY_PHASE1":2},"registry_processing_date":"2026-11-06T10:00:05","modifications":"Counts and phase tallies computed here from the full recruiting result set; trials trimmed to the 25 most recently updated, conditions to 3, countries to 10 distinct; no text edited.","recent_trials":[{"nct_id":"NCT03424005","title":{"text":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer","untrusted":true},"phase":["PHASE1","PHASE2"],"sponsor":{"text":"Hoffmann-La Roche","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-11-06","start_date":"2018-03-30","link":{"text":"https://clinicaltrials.gov/study/NCT03424005","untrusted":true}},{"nct_id":"NCT06169371","title":{"text":"Abemaciclib Dose Escalation to Maintain Intensity (ADE-MI)","untrusted":true},"phase":["PHASE4"],"sponsor":{"text":"University of Illinois Chicago","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-11-06","start_date":"2023-12-28","link":{"text":"https://clinicaltrials.gov/study/NCT06169371","untrusted":true}},{"nct_id":"NCT07214532","title":{"text":"Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer","untrusted":true},"phase":["NA"],"sponsor":{"text":"Natera, Inc.","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-11-05","start_date":"2026-05-08","link":{"text":"https://clinicaltrials.gov/study/NCT07214532","untrusted":true}},{"nct_id":"NCT04633239","title":{"text":"Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer","untrusted":true},"phase":["PHASE1"],"sponsor":{"text":"National Cancer Institute (NCI)","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-11-04","start_date":"2021-07-02","link":{"text":"https://clinicaltrials.gov/study/NCT04633239","untrusted":true}},{"nct_id":"NCT07114601","title":{"text":"A Study of LY4257496 in Participants With Cancer (OMNIRAY)","untrusted":true},"phase":["PHASE1"],"sponsor":{"text":"Eli Lilly and Company","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-11-04","start_date":"2025-08-06","link":{"text":"https://clinicaltrials.gov/study/NCT07114601","untrusted":true}}],"fact_id":"c9465043705339e23ce77cc3"}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Lilly Cares Foundation","untrusted":true},"type":"manufacturer","url":"https://www.lillycares.com/","status":null,"needs_status_check":false,"has_offer":false}],"manufacturer_offers":[],"note":"A program that lists a drug has not decided anything about any person: each program decides who qualifies, and a status other than open means it may not take new patients. 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A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Abemaciclib","untrusted":true},"brand":{"text":"Verzenio","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":286188072.97,"claims":22862,"beneficiaries":4118,"average_spending_per_claim_usd":12518.068103,"fact_id":"731f3a54a2ae005901d0fd38"},{"year":2021,"gross_spending_usd":324570465.28,"claims":24509,"beneficiaries":4406,"average_spending_per_claim_usd":13242.909351,"fact_id":"aa5adc23df0f1dd1fa1272ef"},{"year":2022,"gross_spending_usd":474171738.47,"claims":33805,"beneficiaries":6042,"average_spending_per_claim_usd":14026.674707,"fact_id":"16ace91d5f91db7285df51db"},{"year":2023,"gross_spending_usd":756850867.48,"claims":50481,"beneficiaries":8217,"average_spending_per_claim_usd":14992.786741,"fact_id":"d5af0cf2d5bd16de8ba7d0ab"},{"year":2024,"gross_spending_usd":1056757309.4,"claims":71933,"beneficiaries":11239,"average_spending_per_claim_usd":14690.85551,"fact_id":"4e2bd758520c8f7c6b32acd9"}],"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":8,"all_states_medicaid_reimbursed_usd":12663091.03,"all_states_medicaid_paid_prescriptions":882,"top_states":[{"state":"NV","medicaid_paid_prescriptions":321,"medicaid_reimbursed_usd":4409455.07,"total_reimbursed_usd":4423696.97,"packages":2,"covers":"fee_for_service_only","fact_id":"0a45befbda628c9785c11003"},{"state":"KY","medicaid_paid_prescriptions":127,"medicaid_reimbursed_usd":1624971.78,"total_reimbursed_usd":1624971.78,"packages":1,"covers":"all_record_types","fact_id":"f94b087bd5c8a90e39ef81fc"},{"state":"WI","medicaid_paid_prescriptions":97,"medicaid_reimbursed_usd":1474878.91,"total_reimbursed_usd":1475370.91,"packages":1,"covers":"all_record_types","fact_id":"889c54ec18d81beb9068b805"},{"state":"FL","medicaid_paid_prescriptions":97,"medicaid_reimbursed_usd":1380895.17,"total_reimbursed_usd":1396666.98,"packages":1,"covers":"fee_for_service_only","fact_id":"2e96605c71fb940a9f7b9fd6"},{"state":"AL","medicaid_paid_prescriptions":67,"medicaid_reimbursed_usd":1013657.31,"total_reimbursed_usd":1035536.84,"packages":1,"covers":"all_record_types","fact_id":"56cdf868178f9471b4843b61"},{"state":"OK","medicaid_paid_prescriptions":62,"medicaid_reimbursed_usd":1011196.16,"total_reimbursed_usd":1011323.66,"packages":1,"covers":"fee_for_service_only","fact_id":"f5cba41d77f47480b3d677aa"},{"state":"NM","medicaid_paid_prescriptions":63,"medicaid_reimbursed_usd":948257.42,"total_reimbursed_usd":964334.99,"packages":1,"covers":"all_record_types","fact_id":"da5768084c42b2df4979ab26"},{"state":"CA","medicaid_paid_prescriptions":48,"medicaid_reimbursed_usd":799779.21,"total_reimbursed_usd":799779.21,"packages":1,"covers":"all_record_types","fact_id":"74ef90a5b7d44a942600c927"}],"unlabelled_state_code_xx":null,"built_from_facts":9,"facts_fee_for_service_only":4,"older_year_facts_not_used":90,"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":"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":"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."}