{"answer":{"query":"Gocovri","resolved_as":"applications","packages":10,"applications":["NDA208944"],"identity":{"application_numbers":["NDA208944"],"marketing_categories":["NDA"],"labelers":[{"text":"ADAMAS PHARMA LLC","untrusted":true}],"dosage_forms":[{"text":"CAPSULE, COATED PELLETS","untrusted":true}],"marketing_start":{"earliest":"2017-08-24","latest":"2017-08-24","packages_with_a_start_date":10}},"generic_entry":[{"application":"NDA208944","date":"2038-08-23","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":"11065213","productNo":"001"},"latest_patent_expiry":"2038-08-23","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":26,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":13,"exclusivities_listed":0,"fact_id":"de6efbaed2abe6c66f276422"}],"label_history":{"events_total":3,"non_cmc_events":3,"counts_by_class":{"LABELING":2,"EFFICACY":1},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA208944","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-07-10","documents":[{"type":"Letter","date":"2025-07-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/208944Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-07-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/208944s009lbl.pdf","untrusted":true}}],"fact_id":"3d570d3798bafc0b161fe7d0"},{"application":"NDA208944","submission_no":4,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2021-02-01","documents":[{"type":"Label","date":"2021-02-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208944s004lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-02-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208944Orig1s004ltr.pdf","untrusted":true}}],"fact_id":"3bae688e295a5cac475b1cda"},{"application":"NDA208944","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2020-03-10","documents":[{"type":"Letter","date":"2020-03-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/208944Orig1s003ltr.pdf","untrusted":true}},{"type":"Label","date":"2020-03-10","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/208944s003lbl.pdf","untrusted":true}}],"fact_id":"a6befc9bf8f6cd9bc52d2b33"}],"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":1,"NOT_PROVIDED":1},"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":"NDA208944","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"GOCOVRI","untrusted":true},"form":{"text":"CAPSULE, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"EQ 68.5MG BASE","untrusted":true}},{"application":"NDA208944","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"GOCOVRI","untrusted":true},"form":{"text":"CAPSULE, EXTENDED RELEASE;ORAL","untrusted":true},"strength":{"text":"EQ 137MG BASE","untrusted":true}}]},"supply":{"fda_shortage_status_counts":{},"packages_with_a_termination_date":2,"next_package_termination_dates":["2030-03-31","2030-10-31"],"packages_with_future_termination_date":2,"termination_meaning":"manufacturer-reported last-lot expiry or withdrawal date of one package; other packages and generics can remain"},"spending":{"reported_under":{"generic":{"text":"Amantadine HCl","untrusted":true},"brand":{"text":"Gocovri","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":53349152.54,"claims":20249,"beneficiaries":3092,"average_spending_per_claim_usd":2634.6561578,"fact_id":"88c45420795659e8bd18b749"},{"year":2021,"gross_spending_usd":70562667.58,"claims":25613,"beneficiaries":4092,"average_spending_per_claim_usd":2754.9552017,"fact_id":"afb459c7c02f53df3ab50756"},{"year":2022,"gross_spending_usd":82318372.45,"claims":28142,"beneficiaries":4252,"average_spending_per_claim_usd":2925.1074,"fact_id":"7579f54a5b0cdccf7c3556b8"},{"year":2023,"gross_spending_usd":91875721.08,"claims":29098,"beneficiaries":4464,"average_spending_per_claim_usd":3157.4582817,"fact_id":"6b7898a7a6a9d874bef016a3"},{"year":2024,"gross_spending_usd":99842781.69,"claims":30705,"beneficiaries":4906,"average_spending_per_claim_usd":3251.6782833,"fact_id":"4d9928e4295989840b902dde"}],"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}}},"medicaid_state_utilization":{"year":2025,"states_with_data":2,"all_states_medicaid_reimbursed_usd":398282.66,"all_states_medicaid_paid_prescriptions":127,"top_states":[{"state":"PA","medicaid_paid_prescriptions":70,"medicaid_reimbursed_usd":219020.21,"total_reimbursed_usd":224751.94,"packages":1,"covers":"all_record_types","fact_id":"01abe265e28652578781b7fe"},{"state":"VA","medicaid_paid_prescriptions":57,"medicaid_reimbursed_usd":179262.45,"total_reimbursed_usd":179262.45,"packages":1,"covers":"all_record_types","fact_id":"2d78ea1c53eb0de5b76267d8"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":0,"older_year_facts_not_used":7,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","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":"eab03c8cfc55e1c7254f8255","field":"ndc.listing","entity":"ndc:17772008521"},{"fact_id":"3e876d17c40316f815053022","field":"ndc.listing","entity":"ndc:17772008560"},{"fact_id":"10a66a4ebebd542d08acfda0","field":"ndc.listing","entity":"ndc:17772017021"},{"fact_id":"de6efbaed2abe6c66f276422","field":"drug.generic_entry_earliest","entity":"application:NDA208944"},{"fact_id":"eea27dad88c7d63a12ec433c","field":"drug.patent","entity":"application:NDA208944"},{"fact_id":"3d570d3798bafc0b161fe7d0","field":"drug.label_event","entity":"application:NDA208944"},{"fact_id":"3bae688e295a5cac475b1cda","field":"drug.label_event","entity":"application:NDA208944"},{"fact_id":"a6befc9bf8f6cd9bc52d2b33","field":"drug.label_event","entity":"application:NDA208944"},{"fact_id":"2b8ce0646a5ae0ae1a255b0a","field":"drug.te_code","entity":"application:NDA208944"},{"fact_id":"b648dd63ba450a6b3d584704","field":"drug.marketing_status","entity":"application:NDA208944"},{"fact_id":"4a6dcb55480835e163b12d86","field":"drug.marketing_status","entity":"application:NDA208944"},{"fact_id":"fc802448c0a846338e5d08e6","field":"ndc.product","entity":"ndc:70482008560"},{"fact_id":"2d5005dd5452f3e9000700bc","field":"ndc.product","entity":"ndc:70482017060"},{"fact_id":"88c45420795659e8bd18b749","field":"drug.partd_spending","entity":"drug:amantadine-hcl|gocovri"},{"fact_id":"afb459c7c02f53df3ab50756","field":"drug.partd_spending","entity":"drug:amantadine-hcl|gocovri"},{"fact_id":"7579f54a5b0cdccf7c3556b8","field":"drug.partd_spending","entity":"drug:amantadine-hcl|gocovri"},{"fact_id":"6b7898a7a6a9d874bef016a3","field":"drug.partd_spending","entity":"drug:amantadine-hcl|gocovri"},{"fact_id":"4d9928e4295989840b902dde","field":"drug.partd_spending","entity":"drug:amantadine-hcl|gocovri"},{"fact_id":"01abe265e28652578781b7fe","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70482017060:PA"},{"fact_id":"2d78ea1c53eb0de5b76267d8","field":"ndc.medicaid_state_utilization","entity":"ndc_state:70482017060:VA"}],"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":"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."}