{"answer":{"query":"Relistor","resolved_as":"applications","packages":6,"applications":["NDA021964","NDA208271"],"identity":{"application_numbers":["NDA021964","NDA208271"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true},{"text":"INJECTION, SOLUTION","untrusted":true}],"marketing_start":{"earliest":"2008-04-24","latest":"2016-07-19","packages_with_a_start_date":6}},"generic_entry":[{"application":"NDA021964","date":"2030-12-31","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":"8247425","productNo":"001"},"latest_patent_expiry":"2030-12-31","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":18,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":6,"exclusivities_listed":0,"fact_id":"acdccdd186dfe1ec580e5a2a"},{"application":"NDA208271","date":"2031-03-10","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":"10307417","productNo":"001"},"latest_patent_expiry":"2031-03-10","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":9,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":9,"exclusivities_listed":0,"fact_id":"650b550185a8b2c6256ad991"}],"label_history":{"events_total":15,"non_cmc_events":11,"counts_by_class":{"LABELING":10,"EFFICACY":1},"cmc_events":4,"recent_non_cmc_events":[{"application":"NDA021964","submission_no":19,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-03-14","documents":[{"type":"Label","date":"2018-03-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-03-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021964Orig1s019,208271Orig1s003ltr.pdf","untrusted":true}}],"fact_id":"eb6aecffac31d57f89044318"},{"application":"NDA208271","submission_no":3,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2018-03-14","documents":[{"type":"Label","date":"2018-03-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021964s019,208271s003lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-03-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021964Orig1s019,208271Orig1s003ltr.pdf","untrusted":true}}],"fact_id":"2bcf5ba1508fb70530b7ff6c"},{"application":"NDA021964","submission_no":18,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-08-01","documents":[{"type":"Label","date":"2017-08-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-08-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021964Orig1s018;208271Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"c5aed21905f2d00aee33ca3f"},{"application":"NDA208271","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-08-01","documents":[{"type":"Label","date":"2017-08-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s018,208271s002lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-08-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021964Orig1s018;208271Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"b1f1e939df0273ae664475d3"},{"application":"NDA021964","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-05-16","documents":[{"type":"Label","date":"2017-05-18","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021964s017,208271s001lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-05-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021964Orig1s017,208271Orig1s001ltr.pdf","untrusted":true}}],"fact_id":"d4b1cde28efa143f4ef4dc7c"}],"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":{"AP":3,"NOT_PROVIDED":1},"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":"NDA021964","product_no":"002","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"RELISTOR","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"8MG/0.4ML (8MG/0.4ML)","untrusted":true}},{"application":"NDA021964","product_no":"003","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"RELISTOR","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"12MG/0.6ML (12MG/0.6ML)","untrusted":true}},{"application":"NDA021964","product_no":"001","te_code":"AP","marketing_status":"Prescription","drug_name":{"text":"RELISTOR","untrusted":true},"form":{"text":"SOLUTION;SUBCUTANEOUS","untrusted":true},"strength":{"text":"12MG/0.6ML (12MG/0.6ML)","untrusted":true}},{"application":"NDA208271","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"RELISTOR","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"150MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Methylnaltrexone Bromide","untrusted":true},"brand":{"text":"Relistor*","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":82678459.28,"claims":43315,"beneficiaries":11497,"average_spending_per_claim_usd":1908.7720023,"fact_id":"ef68705eab0c22aec44dea63"},{"year":2021,"gross_spending_usd":95717741.17,"claims":45986,"beneficiaries":12960,"average_spending_per_claim_usd":2081.4539462,"fact_id":"ce5c11a6aa3f282c35e405d5"},{"year":2022,"gross_spending_usd":117077747.78,"claims":50798,"beneficiaries":14184,"average_spending_per_claim_usd":2304.7708134,"fact_id":"2457f2541486a52976c559a1"},{"year":2023,"gross_spending_usd":132882335.1,"claims":54947,"beneficiaries":15141,"average_spending_per_claim_usd":2418.3728884,"fact_id":"7ff287e87e31acefbba1a0e8"},{"year":2024,"gross_spending_usd":134570149.87,"claims":56864,"beneficiaries":15616,"average_spending_per_claim_usd":2366.5262709,"fact_id":"7be0af3a2b3a4555a01e82f8"}],"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":1,"all_states_medicaid_reimbursed_usd":399597.08,"all_states_medicaid_paid_prescriptions":171,"top_states":[{"state":"TN","medicaid_paid_prescriptions":171,"medicaid_reimbursed_usd":399597.08,"total_reimbursed_usd":400086.08,"packages":1,"covers":"all_record_types","fact_id":"1d4ad3af1247b97a82282f1a"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":41,"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":"52f9a2dc8d399773c8dd0c86","field":"ndc.listing","entity":"ndc:65649015006"},{"fact_id":"c1193ad90ce938e414cf3c24","field":"ndc.listing","entity":"ndc:65649015090"},{"fact_id":"0ba27ad964b2e3b95bed4af2","field":"ndc.listing","entity":"ndc:65649055102"},{"fact_id":"acdccdd186dfe1ec580e5a2a","field":"drug.generic_entry_earliest","entity":"application:NDA021964"},{"fact_id":"0677559789b95fbf746d4a42","field":"drug.patent","entity":"application:NDA021964"},{"fact_id":"650b550185a8b2c6256ad991","field":"drug.generic_entry_earliest","entity":"application:NDA208271"},{"fact_id":"5b4f2a0a058dd2a86297baae","field":"drug.patent","entity":"application:NDA208271"},{"fact_id":"eb6aecffac31d57f89044318","field":"drug.label_event","entity":"application:NDA021964"},{"fact_id":"2bcf5ba1508fb70530b7ff6c","field":"drug.label_event","entity":"application:NDA208271"},{"fact_id":"c5aed21905f2d00aee33ca3f","field":"drug.label_event","entity":"application:NDA021964"},{"fact_id":"b1f1e939df0273ae664475d3","field":"drug.label_event","entity":"application:NDA208271"},{"fact_id":"d4b1cde28efa143f4ef4dc7c","field":"drug.label_event","entity":"application:NDA021964"},{"fact_id":"9c91fa564583fb6e9c32aebf","field":"drug.te_code","entity":"application:NDA021964"},{"fact_id":"1499cb020cbfa42b2f2b22f3","field":"drug.marketing_status","entity":"application:NDA021964"},{"fact_id":"458c7cc83456a39cd0a14efa","field":"drug.te_code","entity":"application:NDA021964"},{"fact_id":"ee212c51f9b8db5bb297b0a3","field":"drug.marketing_status","entity":"application:NDA021964"},{"fact_id":"0fd5189ec971f95981900469","field":"drug.te_code","entity":"application:NDA021964"},{"fact_id":"8279af25680c99ce04f28b6c","field":"drug.marketing_status","entity":"application:NDA021964"},{"fact_id":"14d6f20deb1807e3ff4dc817","field":"drug.marketing_status","entity":"application:NDA208271"},{"fact_id":"ef68705eab0c22aec44dea63","field":"drug.partd_spending","entity":"drug:methylnaltrexone-bromide|relistor"},{"fact_id":"ce5c11a6aa3f282c35e405d5","field":"drug.partd_spending","entity":"drug:methylnaltrexone-bromide|relistor"},{"fact_id":"2457f2541486a52976c559a1","field":"drug.partd_spending","entity":"drug:methylnaltrexone-bromide|relistor"},{"fact_id":"7ff287e87e31acefbba1a0e8","field":"drug.partd_spending","entity":"drug:methylnaltrexone-bromide|relistor"},{"fact_id":"7be0af3a2b3a4555a01e82f8","field":"drug.partd_spending","entity":"drug:methylnaltrexone-bromide|relistor"},{"fact_id":"1d4ad3af1247b97a82282f1a","field":"ndc.medicaid_state_utilization","entity":"ndc_state:65649015090:TN"}],"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."}