{"answer":{"query":"Lybalvi","resolved_as":"applications","packages":8,"applications":["NDA213378"],"identity":{"application_numbers":["NDA213378"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2021-09-20","latest":"2021-09-20","packages_with_a_start_date":8}},"generic_entry":[{"application":"NDA213378","date":"2041-11-12","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":"11707466","productNo":"001"},"latest_patent_expiry":"2041-11-12","latest_exclusivity_expiry":"2026-05-28","dated_barriers":60,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":14,"exclusivities_listed":1,"fact_id":"aafdb586c97d0b4b169b5389"}],"label_history":{"events_total":5,"non_cmc_events":5,"counts_by_class":{"LABELING":5},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA213378","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-01-30","documents":[{"type":"Letter","date":"2026-02-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/213378Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-02-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/213378s011lbl.pdf","untrusted":true}}],"fact_id":"f636159b425d6623aef83813"},{"application":"NDA213378","submission_no":8,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-02-28","documents":[{"type":"Label","date":"2025-03-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213378s008lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-04","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213378Orig1s008ltr.pdf","untrusted":true}}],"fact_id":"38c6663dfe42ea73726e6b66"},{"application":"NDA213378","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-01-22","documents":[{"type":"Label","date":"2025-02-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213378s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-02-07","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213378Orig1s009ltr.pdf","untrusted":true}}],"fact_id":"2b19f728efe003e78fadca95"},{"application":"NDA213378","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-01-30","documents":[{"type":"Letter","date":"2024-01-31","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/213378Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-01-31","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/213378s007lbl.pdf","untrusted":true}}],"fact_id":"7a0668e0fa6f42e86c0f6c7c"},{"application":"NDA213378","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-09-25","documents":[{"type":"Label","date":"2023-09-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/213378Orig1s005lbl.pdf","untrusted":true}},{"type":"Letter","date":"2023-09-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/213378Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"e51fae9705af0589cc44c40c"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":4,"te_code_counts":{"NOT_PROVIDED":4},"marketing_status_counts":{"Prescription":4},"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":"NDA213378","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"LYBALVI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"10MG;EQ 10MG BASE","untrusted":true}},{"application":"NDA213378","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"LYBALVI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"15MG;EQ 10MG BASE","untrusted":true}},{"application":"NDA213378","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"LYBALVI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"20MG;EQ 10MG BASE","untrusted":true}},{"application":"NDA213378","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"LYBALVI","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"5MG;EQ 10MG BASE","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Olanzapine/Samidorphan Malate","untrusted":true},"brand":{"text":"Lybalvi","untrusted":true}},"latest_year":2024,"series":[{"year":2021,"gross_spending_usd":1692534.38,"claims":1163,"beneficiaries":766,"average_spending_per_claim_usd":1455.3176096,"fact_id":"7906aac6e82c286b38a964c7"},{"year":2022,"gross_spending_usd":39162463.94,"claims":26490,"beneficiaries":5745,"average_spending_per_claim_usd":1478.3867097,"fact_id":"11a47dfce54033bfb7ebfa62"},{"year":2023,"gross_spending_usd":89971771.28,"claims":56531,"beneficiaries":9246,"average_spending_per_claim_usd":1591.5474922,"fact_id":"cc5ab878e1d266c837ce80e2"},{"year":2024,"gross_spending_usd":127260664.12,"claims":78389,"beneficiaries":11665,"average_spending_per_claim_usd":1623.4505367,"fact_id":"527cd59d01b1756da45a3269"}],"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":"AMBIGUOUS","field":"spending","reason":"2 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"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."}