{"answer":{"query":"Velphoro","resolved_as":"applications","packages":2,"applications":["NDA205109"],"identity":{"application_numbers":["NDA205109"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, CHEWABLE","untrusted":true}],"marketing_start":{"earliest":"2013-11-27","latest":"2013-11-27","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA205109","date":"2035-05-26","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":"10624855*PED","productNo":"001"},"latest_patent_expiry":"2035-05-26","latest_exclusivity_expiry":"2028-01-01","dated_barriers":24,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":11,"exclusivities_listed":2,"fact_id":"61d9b2ae1499727adc734ee0"}],"label_history":{"events_total":8,"non_cmc_events":7,"counts_by_class":{"EFFICACY":2,"LABELING":5},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA205109","submission_no":14,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-10-13","documents":[{"type":"Letter","date":"2026-10-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/205109Orig1s014ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-10-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/205109s014lbl.pdf","untrusted":true}}],"fact_id":"a74db952ef228f29560584eb"},{"application":"NDA205109","submission_no":10,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-08-27","documents":[{"type":"Letter","date":"2024-08-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205109Orig1s010ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-08-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205109s010lbl.pdf","untrusted":true}}],"fact_id":"351a6f77a5fda7e8f22a5c74"},{"application":"NDA205109","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-07-01","documents":[{"type":"Letter","date":"2024-07-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/205109Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-07-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/205109s009lbl.pdf","untrusted":true}}],"fact_id":"4b8487ee3d04c1f8963f06b8"},{"application":"NDA205109","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-02-28","documents":[{"type":"Label","date":"2020-03-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/205109s008lbl.pdf","untrusted":true}},{"type":"Letter","date":"2020-03-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/205109Orig1s008ltr.pdf","untrusted":true}}],"fact_id":"1dc4c19f762357d4d80d094c"},{"application":"NDA205109","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-04-25","documents":[{"type":"Label","date":"2018-04-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/205109s006lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-04-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/205109Orig1s006ltr.pdf","untrusted":true}}],"fact_id":"9bd84f07c441c2e5f694a930"}],"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":"NDA205109","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"VELPHORO","untrusted":true},"form":{"text":"TABLET, CHEWABLE;ORAL","untrusted":true},"strength":{"text":"EQ 250MG IRON","untrusted":true}},{"application":"NDA205109","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"VELPHORO","untrusted":true},"form":{"text":"TABLET, CHEWABLE;ORAL","untrusted":true},"strength":{"text":"EQ 500MG IRON","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Sucroferric Oxyhydroxide","untrusted":true},"brand":{"text":"Velphoro","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":343032074.74,"claims":123235,"beneficiaries":29839,"average_spending_per_claim_usd":2783.5604718,"fact_id":"c2ab12f544ad01860f33edb3"},{"year":2021,"gross_spending_usd":380608096.36,"claims":126367,"beneficiaries":30774,"average_spending_per_claim_usd":3011.9263444,"fact_id":"0c88d54d47e7314487ed9949"},{"year":2022,"gross_spending_usd":426893782.41,"claims":139368,"beneficiaries":33445,"average_spending_per_claim_usd":3063.068871,"fact_id":"f7b2d081335e849a23d16a85"},{"year":2023,"gross_spending_usd":465812435.29,"claims":153366,"beneficiaries":36082,"average_spending_per_claim_usd":3037.2601182,"fact_id":"8f926acb77bd9e9fa590f073"},{"year":2024,"gross_spending_usd":438436195.16,"claims":156980,"beneficiaries":38351,"average_spending_per_claim_usd":2792.9430192,"fact_id":"7e08a706180eb2c21ffc9542"}],"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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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":"7c8b3f80d3f142add1dd7fd7","field":"ndc.listing","entity":"ndc:49230064551"},{"fact_id":"60bb75382d64501725ccffa6","field":"ndc.listing","entity":"ndc:49230064661"},{"fact_id":"61d9b2ae1499727adc734ee0","field":"drug.generic_entry_earliest","entity":"application:NDA205109"},{"fact_id":"9a15240d5de8ddf961a71a9c","field":"drug.patent","entity":"application:NDA205109"},{"fact_id":"af24e394b6f2d6fb6ab20fb5","field":"drug.exclusivity","entity":"application:NDA205109"},{"fact_id":"a74db952ef228f29560584eb","field":"drug.label_event","entity":"application:NDA205109"},{"fact_id":"351a6f77a5fda7e8f22a5c74","field":"drug.label_event","entity":"application:NDA205109"},{"fact_id":"4b8487ee3d04c1f8963f06b8","field":"drug.label_event","entity":"application:NDA205109"},{"fact_id":"1dc4c19f762357d4d80d094c","field":"drug.label_event","entity":"application:NDA205109"},{"fact_id":"9bd84f07c441c2e5f694a930","field":"drug.label_event","entity":"application:NDA205109"},{"fact_id":"f6cedfd6218baaea93b3541e","field":"drug.marketing_status","entity":"application:NDA205109"},{"fact_id":"2529c6269a8a9463beaddcba","field":"drug.marketing_status","entity":"application:NDA205109"},{"fact_id":"c2ab12f544ad01860f33edb3","field":"drug.partd_spending","entity":"drug:sucroferric-oxyhydroxide|velphoro"},{"fact_id":"0c88d54d47e7314487ed9949","field":"drug.partd_spending","entity":"drug:sucroferric-oxyhydroxide|velphoro"},{"fact_id":"f7b2d081335e849a23d16a85","field":"drug.partd_spending","entity":"drug:sucroferric-oxyhydroxide|velphoro"},{"fact_id":"8f926acb77bd9e9fa590f073","field":"drug.partd_spending","entity":"drug:sucroferric-oxyhydroxide|velphoro"},{"fact_id":"7e08a706180eb2c21ffc9542","field":"drug.partd_spending","entity":"drug:sucroferric-oxyhydroxide|velphoro"},{"fact_id":"cc927c838c31523deda7ba05","field":"ndc.medicaid_state_utilization","entity":"ndc_state:49230064551:SC"},{"fact_id":"31212315fa474c0f942db6a1","field":"ndc.medicaid_state_utilization","entity":"ndc_state:49230064551:NE"},{"fact_id":"8e4decbedefdb633c4a91657","field":"ndc.medicaid_state_utilization","entity":"ndc_state:49230064551:UT"}],"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."}