{"answer":{"query":"Glyxambi","resolved_as":"applications","packages":6,"applications":["NDA206073"],"identity":{"application_numbers":["NDA206073"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2015-01-30","latest":"2015-01-30","packages_with_a_start_date":6}},"generic_entry":[{"application":"NDA206073","date":"2037-12-08","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":"12364700*PED","productNo":"001"},"latest_patent_expiry":"2037-12-08","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":54,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":15,"exclusivities_listed":0,"fact_id":"07749ff833f651206d8a4cea"}],"label_history":{"events_total":20,"non_cmc_events":20,"counts_by_class":{"LABELING":17,"EFFICACY":3},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA206073","submission_no":44,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-10-24","documents":[{"type":"Label","date":"2025-10-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/206073s044lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204629Orig1s063,206111Orig1s046,208658Orig1s034,206073Orig1s044,212614Orig1s029ltr.pdf","untrusted":true}}],"fact_id":"050e39ec4c23881c64c6304a"},{"application":"NDA206073","submission_no":36,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-10-30","documents":[{"type":"Label","date":"2023-10-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206073s036lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-10-31","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206073Orig1s036; 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enrollment is decided by the study team.","ingredients":[{"ingredient":{"text":"EMPAGLIFLOZIN","untrusted":true},"recruiting_interventional_count":94,"not_yet_recruiting_count":29,"by_phase":{"PHASE1/PHASE2":4,"PHASE3":18,"PHASE1":7,"PHASE4":29,"PHASE2":18,"EARLY_PHASE1":8,"NA":6,"PHASE2/PHASE3":4},"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":"NCT05972564","title":{"text":"The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function","untrusted":true},"phase":["PHASE1","PHASE2"],"sponsor":{"text":"Vanderbilt University Medical Center","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-11-05","start_date":"2023-09-06","link":{"text":"https://clinicaltrials.gov/study/NCT05972564","untrusted":true}},{"nct_id":"NCT07038356","title":{"text":"Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure","untrusted":true},"phase":["PHASE3"],"sponsor":{"text":"Christian Schulze","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-11-04","start_date":"2025-12-08","link":{"text":"https://clinicaltrials.gov/study/NCT07038356","untrusted":true}},{"nct_id":"NCT07845630","title":{"text":"A Study in Healthy People to Compare How 2 Different Formulations of Vicadrostat / Empagliflozin Tablets Are Taken up in the Body","untrusted":true},"phase":["PHASE1"],"sponsor":{"text":"Boehringer Ingelheim","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-10-29","start_date":"2026-10-14","link":{"text":"https://clinicaltrials.gov/study/NCT07845630","untrusted":true}},{"nct_id":"NCT06249932","title":{"text":"Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease","untrusted":true},"phase":["PHASE4"],"sponsor":{"text":"National Taiwan University Hospital","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-10-28","start_date":"2024-03-13","link":{"text":"https://clinicaltrials.gov/study/NCT06249932","untrusted":true}}],"fact_id":"ab0e426b6d1a73f39080ec45"},{"ingredient":{"text":"LINAGLIPTIN","untrusted":true},"recruiting_interventional_count":6,"not_yet_recruiting_count":6,"by_phase":{"PHASE4":4,"PHASE3":1,"NA":1},"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":"NCT06862739","title":{"text":"Glycemic Control With Triple Pathway Approach Through Empagliflozin, Linagliptin and Metformin Combination","untrusted":true},"phase":["PHASE4"],"sponsor":{"text":"Nabiqasim Industries (Pvt) Ltd","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-04-17","start_date":"2025-10-30","link":{"text":"https://clinicaltrials.gov/study/NCT06862739","untrusted":true}},{"nct_id":"NCT07442006","title":{"text":"Glycemic Variability of Combination Therapies in T2DM","untrusted":true},"phase":["PHASE4"],"sponsor":{"text":"JW Pharmaceutical","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-03-02","start_date":"2025-10-29","link":{"text":"https://clinicaltrials.gov/study/NCT07442006","untrusted":true}},{"nct_id":"NCT04670666","title":{"text":"Efficacy and Safety of Madalena Association in the Treatment of Type II Diabetes Mellitus","untrusted":true},"phase":["PHASE3"],"sponsor":{"text":"EMS","untrusted":true},"status":"RECRUITING","last_update_posted":"2025-12-08","start_date":"2024-11-18","link":{"text":"https://clinicaltrials.gov/study/NCT04670666","untrusted":true}},{"nct_id":"NCT07019012","title":{"text":"Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.","untrusted":true},"phase":["PHASE4"],"sponsor":{"text":"Huazhong University of Science and Technology","untrusted":true},"status":"RECRUITING","last_update_posted":"2025-06-13","start_date":"2025-07-30","link":{"text":"https://clinicaltrials.gov/study/NCT07019012","untrusted":true}},{"nct_id":"NCT06095492","title":{"text":"Effect of Empagliflozin vs Linagliptin on Glycemic Outcomes,Renal Outcomes & Body Composition in Renal Transplant Recipients With Diabetes Mellitus","untrusted":true},"phase":["NA"],"sponsor":{"text":"Medanta, The Medicity, India","untrusted":true},"status":"RECRUITING","last_update_posted":"2024-12-05","start_date":"2023-10-30","link":{"text":"https://clinicaltrials.gov/study/NCT06095492","untrusted":true}}],"fact_id":"602880f8078a0b44009e6d5f"}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Boehringer Ingelheim Cares Foundation","untrusted":true},"type":"manufacturer","url":"https://www.boehringer-ingelheim.com/us/boehringer-ingelheim-cares-foundation","status":{"state":"limited","effective":"2026-10-15","applies_to":null,"detail":{"text":"No new patient enrollments for individuals with Medicare Part D or Medicare Advantage prescription drug coverage for Boehringer Ingelheim primary care products (Combivent Respimat, Glyxambi, Jardiance, Jentadueto, Jentadueto XR, Spiriva Respimat, Stiolto Respimat, Synjardy, Synjardy XR, Tradjenta, Trijardy XR). Part D patients actively enrolled as of 2026-10-15 continue through their current enrollment period and may be eligible in 2027 only after annual re-enrollment. Product removals: Cyltezo 2026-07-15; OFEV 2026-09-11 (active patients continue through the end of their enrollment or 2027-12-31); no new enrollments for Aptivus, Atrovent and Striverdi from 2026-10-15.","untrusted":true},"read_on":"2026-11-06T12:00:00.000Z","source_url":"https://www.boehringer-ingelheim.com/us/about-us/sustainable-development/our-commitment/pdf/pap-important-updates","proof_state":"eyes_checked"},"needs_status_check":true,"has_offer":false},{"name":{"text":"Jardiance Savings Card (BI/Lilly)","untrusted":true},"type":"manufacturer","url":"https://patient.boehringer-ingelheim.com/us/products/jardiance/savings/","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. Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Empagliflozin/Linagliptin","untrusted":true},"brand":{"text":"Glyxambi","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":71473721.59,"claims":78812,"beneficiaries":17258,"average_spending_per_claim_usd":906.88881883,"fact_id":"975658297388d9938edf26ca"},{"year":2021,"gross_spending_usd":91483191.59,"claims":95763,"beneficiaries":20850,"average_spending_per_claim_usd":955.30832984,"fact_id":"3ff045b068329fe861afd357"},{"year":2022,"gross_spending_usd":114232906,"claims":111877,"beneficiaries":24241,"average_spending_per_claim_usd":1021.0580012,"fact_id":"3dc4c88c11c26d6e64b8884c"},{"year":2023,"gross_spending_usd":136590647.79,"claims":124359,"beneficiaries":27116,"average_spending_per_claim_usd":1098.3575599,"fact_id":"3b01d24f7dd3e75445ef4001"},{"year":2024,"gross_spending_usd":141061135.08,"claims":136734,"beneficiaries":28725,"average_spending_per_claim_usd":1031.6463724,"fact_id":"074bf7fd1d7c8d486d021bee"}],"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}}},"orphan_designation":{"ingredients":[{"ingredient":{"text":"empagliflozin","untrusted":true},"designation_count":1,"approved_count":0,"recent":[{"designated":"2026-11-02","use":{"text":"treatment of glycogen storage disease type 1b (GSD1b)","untrusted":true},"status":"Designated","sponsor":{"text":"Vitalis Scientia LLC","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"2bdcac1644e899b98d840283"}],"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":1,"all_states_medicaid_reimbursed_usd":77178.26,"all_states_medicaid_paid_prescriptions":112,"top_states":[{"state":"KY","medicaid_paid_prescriptions":112,"medicaid_reimbursed_usd":77178.26,"total_reimbursed_usd":77178.26,"packages":1,"covers":"all_record_types","fact_id":"62ef1cdcf24b5b5bce8dbf53"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":43,"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":"a2471d617545b779073ee50b","field":"ndc.listing","entity":"ndc:00597016430"},{"fact_id":"4b85b7e9e1ced8b0deaeccea","field":"ndc.listing","entity":"ndc:00597016439"},{"fact_id":"b254a6e5a4b1d9380518d7ed","field":"ndc.listing","entity":"ndc:00597016490"},{"fact_id":"07749ff833f651206d8a4cea","field":"drug.generic_entry_earliest","entity":"application:NDA206073"},{"fact_id":"bc7a81745263f6108208b181","field":"drug.patent","entity":"application:NDA206073"},{"fact_id":"050e39ec4c23881c64c6304a","field":"drug.label_event","entity":"application:NDA206073"},{"fact_id":"8de8fba2d7a75b5ca2034470","field":"drug.label_event","entity":"application:NDA206073"},{"fact_id":"059b6516a700d4fde670840c","field":"drug.label_event","entity":"application:NDA206073"},{"fact_id":"874dc628196205c85d960ba3","field":"drug.label_event","entity":"application:NDA206073"},{"fact_id":"6ed332cd1a4c5ecb75065151","field":"drug.label_event","entity":"application:NDA206073"},{"fact_id":"9de892cc3cf1dcdb8a06d28e","field":"drug.marketing_status","entity":"application:NDA206073"},{"fact_id":"37bd42c564bbf7d46ce6310e","field":"drug.marketing_status","entity":"application:NDA206073"},{"fact_id":"5092f686ae27ac6007bd6482","field":"ndc.recall","entity":"ndc:00597016430"},{"fact_id":"ab0e426b6d1a73f39080ec45","field":"drug.trial_access","entity":"drug:empagliflozin"},{"fact_id":"602880f8078a0b44009e6d5f","field":"drug.trial_access","entity":"drug:linagliptin"},{"fact_id":"68df1ac006fe0604fce257f6","field":"program.status","entity":"program:boehringer-ingelheim-cares"},{"fact_id":"975658297388d9938edf26ca","field":"drug.partd_spending","entity":"drug:empagliflozin-linagliptin|glyxambi"},{"fact_id":"3ff045b068329fe861afd357","field":"drug.partd_spending","entity":"drug:empagliflozin-linagliptin|glyxambi"},{"fact_id":"3dc4c88c11c26d6e64b8884c","field":"drug.partd_spending","entity":"drug:empagliflozin-linagliptin|glyxambi"},{"fact_id":"3b01d24f7dd3e75445ef4001","field":"drug.partd_spending","entity":"drug:empagliflozin-linagliptin|glyxambi"},{"fact_id":"074bf7fd1d7c8d486d021bee","field":"drug.partd_spending","entity":"drug:empagliflozin-linagliptin|glyxambi"},{"fact_id":"2bdcac1644e899b98d840283","field":"drug.orphan_designation","entity":"drug:empagliflozin"},{"fact_id":"62ef1cdcf24b5b5bce8dbf53","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00597016430:KY"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["AMBER","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":"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":"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."}