{"answer":{"query":"Prevymis","resolved_as":"applications","packages":8,"applications":["NDA209939","NDA209940","NDA219104"],"identity":{"application_numbers":["NDA209939","NDA209940","NDA219104"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true},{"text":"INJECTION, SOLUTION","untrusted":true},{"text":"PELLET","untrusted":true}],"marketing_start":{"earliest":"2017-11-08","latest":"2024-08-30","packages_with_a_start_date":8}},"generic_entry":[{"application":"NDA209939","date":"2031-08-30","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":"exclusivity","ref":"ODE-495","productNo":"001"},"latest_patent_expiry":"2029-01-18","latest_exclusivity_expiry":"2031-08-30","dated_barriers":14,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":6,"fact_id":"ba1a6b367ad16d8c22e7535a"},{"application":"NDA209940","date":"2033-02-28","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; 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209940Orig1s012, 016lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-09-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209939Orig1s013, s016; 209940Orig1s012, 016ltr.pdf","untrusted":true}}],"fact_id":"659dd63822d397e68a80691f"},{"application":"NDA209940","submission_no":16,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-08-30","documents":[{"type":"Label","date":"2024-10-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209939Orig1s013, s016; 209940Orig1s012, 016lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-09-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209939Orig1s013, s016; 209940Orig1s012, 016ltr.pdf","untrusted":true}}],"fact_id":"899daa7ce801f14a01d39063"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":6,"te_code_counts":{"NOT_PROVIDED":6},"marketing_status_counts":{"Prescription":6},"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":"NDA209939","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PREVYMIS","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"240MG","untrusted":true}},{"application":"NDA209939","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PREVYMIS","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"480MG","untrusted":true}},{"application":"NDA209940","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PREVYMIS","untrusted":true},"form":{"text":"SOLUTION;INTRAVENOUS","untrusted":true},"strength":{"text":"480MG/24ML (20MG/ML)","untrusted":true}},{"application":"NDA209940","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PREVYMIS","untrusted":true},"form":{"text":"SOLUTION;INTRAVENOUS","untrusted":true},"strength":{"text":"240MG/12ML (20MG/ML)","untrusted":true}},{"application":"NDA219104","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PREVYMIS","untrusted":true},"form":{"text":"PELLETS;ORAL","untrusted":true},"strength":{"text":"20MG/PACKET","untrusted":true}},{"application":"NDA219104","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PREVYMIS","untrusted":true},"form":{"text":"PELLETS;ORAL","untrusted":true},"strength":{"text":"120MG/PACKET","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Letermovir","untrusted":true},"brand":{"text":"Prevymis*","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":28098444.74,"claims":4225,"beneficiaries":1157,"average_spending_per_claim_usd":6650.5194651,"fact_id":"e03cfd0c8fe7dcace03d18eb"},{"year":2021,"gross_spending_usd":38109251.45,"claims":5406,"beneficiaries":1463,"average_spending_per_claim_usd":7049.4360803,"fact_id":"f0e10baecdba9db13b21cac3"},{"year":2022,"gross_spending_usd":48827212.32,"claims":6698,"beneficiaries":1723,"average_spending_per_claim_usd":7289.8196954,"fact_id":"d284d2223c1ac5c14ce97b05"},{"year":2023,"gross_spending_usd":73949061.88,"claims":9840,"beneficiaries":2391,"average_spending_per_claim_usd":7515.148565,"fact_id":"c1efd9c484282140b75d88e2"},{"year":2024,"gross_spending_usd":120450530.64,"claims":16441,"beneficiaries":3884,"average_spending_per_claim_usd":7326.2289788,"fact_id":"a6ded8afbbcf306e6e090f7e"}],"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."}