{"answer":{"query":"Invokana","resolved_as":"applications","packages":16,"applications":["NDA204042"],"identity":{"application_numbers":["NDA204042"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2013-03-29","latest":"2020-05-05","packages_with_a_start_date":16}},"generic_entry":[{"application":"NDA204042","date":"2029-08-26","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":"7943582*PED","productNo":"001"},"latest_patent_expiry":"2029-08-26","latest_exclusivity_expiry":"2028-06-18","dated_barriers":16,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":3,"exclusivities_listed":2,"fact_id":"19fc662bbc39bb79a6b10ce6"}],"label_history":{"events_total":26,"non_cmc_events":21,"counts_by_class":{"LABELING":14,"EFFICACY":7},"cmc_events":5,"recent_non_cmc_events":[{"application":"NDA204042","submission_no":44,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-06-03","documents":[{"type":"Letter","date":"2026-06-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/204042Orig1s044ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-06-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204042s044lbl.pdf","untrusted":true}}],"fact_id":"4d28050c1d7559e1046a1039"},{"application":"NDA204042","submission_no":43,"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/2024/204042s043lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-12-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204042Orig1s043;204353Orig1s046;205879Orig1s023ltr.pdf","untrusted":true}}],"fact_id":"fa3499e48c36ae798a90f841"},{"application":"NDA204042","submission_no":42,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-23","documents":[{"type":"Label","date":"2024-08-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204042s041s042lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-08-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204042Orig1s041, s042ltr.pdf","untrusted":true}}],"fact_id":"d99280dbcd266fc393483238"},{"application":"NDA204042","submission_no":41,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-23","documents":[{"type":"Label","date":"2024-08-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/204042s041s042lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-08-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/204042Orig1s041, s042ltr.pdf","untrusted":true}}],"fact_id":"4b99d0d2f830166dffd45ed5"},{"application":"NDA204042","submission_no":40,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-07-05","documents":[{"type":"Label","date":"2023-07-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204042s040lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-07-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/204042Orig1s040ltr.pdf","untrusted":true}}],"fact_id":"78f213ee6a91251f323c636b"}],"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":{"AB":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":"NDA204042","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INVOKANA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"300MG","untrusted":true}},{"application":"NDA204042","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INVOKANA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"100MG","untrusted":true}}]},"assistance_and_offers":{"programs_listing_this_drug":[{"name":{"text":"Johnson & Johnson Patient Assistance Program","untrusted":true},"type":"manufacturer","url":"https://www.jnjwithme.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. 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":"Canagliflozin","untrusted":true},"brand":{"text":"Invokana","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":571448118.91,"claims":621988,"beneficiaries":133550,"average_spending_per_claim_usd":918.74460425,"fact_id":"2efbd3ea4da877b9359a57df"},{"year":2021,"gross_spending_usd":456386877.99,"claims":468582,"beneficiaries":109273,"average_spending_per_claim_usd":973.97441214,"fact_id":"45b585e9cf8c463517644f16"},{"year":2022,"gross_spending_usd":427366294.95,"claims":396347,"beneficiaries":88388,"average_spending_per_claim_usd":1078.262974,"fact_id":"5616871bd863def5808d26e6"},{"year":2023,"gross_spending_usd":357419494.24,"claims":305908,"beneficiaries":69576,"average_spending_per_claim_usd":1168.3888432,"fact_id":"f8b4c4014e534594f4f7bd82"},{"year":2024,"gross_spending_usd":272062235.32,"claims":255843,"beneficiaries":55993,"average_spending_per_claim_usd":1063.3952671,"fact_id":"d5202c9b0fb5cc3cba49e751"}],"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}}},"safety_communication":{"notices":[{"title":{"text":"FDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)","untrusted":true},"issued":"2020-08-26","url":"https://www.fda.gov/drugs/drug-safety-and-availability/fda-removes-boxed-warning-about-risk-leg-and-foot-amputations-diabetes-medicine-canagliflozin","read_on":"2026-11-07T20:11:11.310Z","fact_id":"7d2248c8fc4db6a42fe42f27"}],"reading":"the notice as FDA published it, listed unchanged; OmniRx does not interpret it or say whether it applies to a given treatment; only the newest notice per drug is held"},"medicaid_state_utilization":{"year":2025,"states_with_data":1,"all_states_medicaid_reimbursed_usd":154602.07,"all_states_medicaid_paid_prescriptions":226,"top_states":[{"state":"OK","medicaid_paid_prescriptions":226,"medicaid_reimbursed_usd":154602.07,"total_reimbursed_usd":154602.07,"packages":2,"covers":"fee_for_service_only","fact_id":"8ea56b51120fb9ea4d372299"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":2,"older_year_facts_not_used":123,"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":"16329641b657874390f1c703","field":"ndc.listing","entity":"ndc:50090436400"},{"fact_id":"9db9295197d7f274eb0ce8d4","field":"ndc.listing","entity":"ndc:50090502900"},{"fact_id":"120968076aadede21aa2d52c","field":"ndc.listing","entity":"ndc:50090503400"},{"fact_id":"19fc662bbc39bb79a6b10ce6","field":"drug.generic_entry_earliest","entity":"application:NDA204042"},{"fact_id":"c3fb781d2b406fa197174716","field":"drug.patent","entity":"application:NDA204042"},{"fact_id":"0518350f3a1b973757c6fb48","field":"drug.exclusivity","entity":"application:NDA204042"},{"fact_id":"4d28050c1d7559e1046a1039","field":"drug.label_event","entity":"application:NDA204042"},{"fact_id":"fa3499e48c36ae798a90f841","field":"drug.label_event","entity":"application:NDA204042"},{"fact_id":"d99280dbcd266fc393483238","field":"drug.label_event","entity":"application:NDA204042"},{"fact_id":"4b99d0d2f830166dffd45ed5","field":"drug.label_event","entity":"application:NDA204042"},{"fact_id":"78f213ee6a91251f323c636b","field":"drug.label_event","entity":"application:NDA204042"},{"fact_id":"cadb37b24fe04832b1067ffa","field":"drug.te_code","entity":"application:NDA204042"},{"fact_id":"063f97e539923cb7d6f9f0a8","field":"drug.marketing_status","entity":"application:NDA204042"},{"fact_id":"5fba5c1cdf275a5427bf158d","field":"drug.te_code","entity":"application:NDA204042"},{"fact_id":"2ac21893373378b21fd4659f","field":"drug.marketing_status","entity":"application:NDA204042"},{"fact_id":"2efbd3ea4da877b9359a57df","field":"drug.partd_spending","entity":"drug:canagliflozin|invokana"},{"fact_id":"45b585e9cf8c463517644f16","field":"drug.partd_spending","entity":"drug:canagliflozin|invokana"},{"fact_id":"5616871bd863def5808d26e6","field":"drug.partd_spending","entity":"drug:canagliflozin|invokana"},{"fact_id":"f8b4c4014e534594f4f7bd82","field":"drug.partd_spending","entity":"drug:canagliflozin|invokana"},{"fact_id":"d5202c9b0fb5cc3cba49e751","field":"drug.partd_spending","entity":"drug:canagliflozin|invokana"},{"fact_id":"7d2248c8fc4db6a42fe42f27","field":"drug.safety_communication","entity":"drug:canagliflozin"},{"fact_id":"8ea56b51120fb9ea4d372299","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50458014130:OK"}],"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":"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"}],"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."}