{"answer":{"query":"Amvuttra","resolved_as":"applications","packages":1,"applications":["NDA215515"],"identity":{"application_numbers":["NDA215515"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"INJECTION","untrusted":true}],"marketing_start":{"earliest":"2022-06-13","latest":"2022-06-13","packages_with_a_start_date":1}},"generic_entry":[{"application":"NDA215515","date":"2036-07-28","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":"10208307","productNo":"001"},"latest_patent_expiry":"2036-07-28","latest_exclusivity_expiry":"2032-03-20","dated_barriers":17,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":13,"exclusivities_listed":4,"fact_id":"ee2e86eee62c6570f10c41f7"}],"label_history":{"events_total":3,"non_cmc_events":3,"counts_by_class":{"EFFICACY":1,"LABELING":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA215515","submission_no":6,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-03-20","documents":[{"type":"Letter","date":"2025-03-24","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215515Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-03-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215515s006lbl.pdf","untrusted":true}}],"fact_id":"34915194b57028138b186329"},{"application":"NDA215515","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-11","documents":[{"type":"Letter","date":"2025-03-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/215515Orig1s005ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-03-14","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215515s005lbl.pdf","untrusted":true}}],"fact_id":"c070d1d536f0075f414b7abe"},{"application":"NDA215515","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-02-16","documents":[{"type":"Letter","date":"2023-02-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215515Orig1s002ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-02-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215515s002lbl.pdf","untrusted":true}}],"fact_id":"14d9679d420518ec9c321ac2"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":1,"te_code_counts":{"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":1},"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":"NDA215515","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"AMVUTTRA","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Vutrisiran Sodium","untrusted":true},"brand":{"text":"Amvuttra","untrusted":true}},"latest_year":2024,"series":[{"year":2022,"gross_spending_usd":11434837.68,"claims":98,"beneficiaries":68,"average_spending_per_claim_usd":116682.01714,"fact_id":"ccfdd086622fc4d83aa90832"},{"year":2023,"gross_spending_usd":67368549.29,"claims":562,"beneficiaries":195,"average_spending_per_claim_usd":119872.86351,"fact_id":"5fd7d6d96acc15de847e1869"},{"year":2024,"gross_spending_usd":140924646.88,"claims":1192,"beneficiaries":409,"average_spending_per_claim_usd":118225.3749,"fact_id":"59415b52c6ff6790a8e3c180"}],"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}}},"payment_limit":{"codes":[{"hcpcs":"J0225","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":5008.939,"dosage_descriptor":{"text":"1 MG","untrusted":true},"packages_matched":1,"read_on":"2026-11-07T07:31:28.000Z","source_url":{"text":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","untrusted":true},"fact_id":"c3d3dd38be1f0806cc2f9b5c"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; not a price a patient pays, and the presence of a code does not indicate that Medicare covers a product"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"vutrisiran","untrusted":true},"designation_count":2,"approved_count":2,"recent":[{"designated":"2018-05-25","use":{"text":"Treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis)","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Alnylam Pharmaceuticals, Inc.","untrusted":true},"approved":true},{"designated":"2018-05-25","use":{"text":"Treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis)","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Alnylam Pharmaceuticals, Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"1589e7f1af49c73fbd7eec0a"}],"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":2024,"states_with_data":0,"all_states_medicaid_reimbursed_usd":0,"all_states_medicaid_paid_prescriptions":0,"top_states":[],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":116,"medicaid_reimbursed_usd":10905737.84,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":1,"facts_fee_for_service_only":1,"older_year_facts_not_used":0,"dataset":"State Drug Utilization Data 2024","read_on":"2026-11-07T23:59:45.983Z","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":"53ac55d66cdb0e3eae809d4e","field":"ndc.listing","entity":"ndc:71336100301"},{"fact_id":"ee2e86eee62c6570f10c41f7","field":"drug.generic_entry_earliest","entity":"application:NDA215515"},{"fact_id":"82cb6982b7a2f4ff174bc50c","field":"drug.patent","entity":"application:NDA215515"},{"fact_id":"174b225cc8b362e7590137c4","field":"drug.exclusivity","entity":"application:NDA215515"},{"fact_id":"34915194b57028138b186329","field":"drug.label_event","entity":"application:NDA215515"},{"fact_id":"c070d1d536f0075f414b7abe","field":"drug.label_event","entity":"application:NDA215515"},{"fact_id":"14d9679d420518ec9c321ac2","field":"drug.label_event","entity":"application:NDA215515"},{"fact_id":"816b8c50281f113091973d38","field":"drug.marketing_status","entity":"application:NDA215515"},{"fact_id":"ccfdd086622fc4d83aa90832","field":"drug.partd_spending","entity":"drug:vutrisiran-sodium|amvuttra"},{"fact_id":"5fd7d6d96acc15de847e1869","field":"drug.partd_spending","entity":"drug:vutrisiran-sodium|amvuttra"},{"fact_id":"59415b52c6ff6790a8e3c180","field":"drug.partd_spending","entity":"drug:vutrisiran-sodium|amvuttra"},{"fact_id":"c3d3dd38be1f0806cc2f9b5c","field":"drug.asp_price","entity":"hcpcs:J0225"},{"fact_id":"1589e7f1af49c73fbd7eec0a","field":"drug.orphan_designation","entity":"drug:vutrisiran"}],"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":"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."}