{"answer":{"query":"Inlyta","resolved_as":"applications","packages":4,"applications":["NDA202324"],"identity":{"application_numbers":["NDA202324"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2012-01-27","latest":"2012-01-27","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA202324","date":"2037-07-12","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":"10869924*PED","productNo":"001"},"latest_patent_expiry":"2037-07-12","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":16,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":0,"fact_id":"7b3e1d9b7a613bb41b3cfc90"}],"label_history":{"events_total":10,"non_cmc_events":8,"counts_by_class":{"LABELING":6,"EFFICACY":2},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA202324","submission_no":16,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-07-16","documents":[{"type":"Letter","date":"2024-07-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202324Orig1s016ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-07-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202324s016lbl.pdf","untrusted":true}}],"fact_id":"654036639023533fa5f95be1"},{"application":"NDA202324","submission_no":14,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-09-22","documents":[{"type":"Label","date":"2022-10-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/202324Orig1s014CorrectedLbl.pdf","untrusted":true}},{"type":"Letter","date":"2022-09-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/202324Orig1s014Correctedltr.pdf","untrusted":true}}],"fact_id":"8ae9e3a8d617ecd5722882d7"},{"application":"NDA202324","submission_no":11,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2020-06-04","documents":[{"type":"Label","date":"2020-06-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202324s011lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-06-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202324Orig1s011ltr.pdf","untrusted":true}}],"fact_id":"89af71d061b6762153a201e9"},{"application":"NDA202324","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-01-23","documents":[{"type":"Letter","date":"2020-01-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/202324Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-01-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/202324s010lbl.pdf","untrusted":true}}],"fact_id":"52e7df5ea7a08b30b8af5e59"},{"application":"NDA202324","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-08-10","documents":[{"type":"Label","date":"2018-08-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202324s008lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-08-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202324Orig1s008ltr.pdf","untrusted":true}}],"fact_id":"2e6899dac61b89378b4d7f06"}],"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":"NDA202324","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INLYTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"5MG","untrusted":true}},{"application":"NDA202324","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"INLYTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"1MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Axitinib","untrusted":true},"brand":{"text":"Inlyta","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":263233497.04,"claims":17260,"beneficiaries":3797,"average_spending_per_claim_usd":15251.071671,"fact_id":"fff205ef5d2da1c93d31904d"},{"year":2021,"gross_spending_usd":376064184.98,"claims":23538,"beneficiaries":4636,"average_spending_per_claim_usd":15976.896295,"fact_id":"3cebbeb9964cd5dd2aa7c8cd"},{"year":2022,"gross_spending_usd":417577746.44,"claims":24578,"beneficiaries":4737,"average_spending_per_claim_usd":16989.899359,"fact_id":"c9ebe84dc3409d332bbc1cd2"},{"year":2023,"gross_spending_usd":466771313.72,"claims":25243,"beneficiaries":4739,"average_spending_per_claim_usd":18491.118873,"fact_id":"a5d859c63d495f79bc32a9ed"},{"year":2024,"gross_spending_usd":438904955.79,"claims":24770,"beneficiaries":4465,"average_spending_per_claim_usd":17719.21501,"fact_id":"0eef52defc2cafaa84bc2cde"}],"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; 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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":"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":"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."}