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Orlaam's unique mechanism of action, targeting the potassium voltage-gated channel subfamily H member 2, distinguishes it from other opioids and may offer a novel approach to managing withdrawal symptoms and cravings. The primary risk to Orlaam's market position is the strong presence of off-patent generics, particularly methadone, which has 13 generic formulations, and the upcoming key composition patent expiry in 2028.","approvals":[{"date":"1993-07-09","orphan":true,"company":"ROXANE","regulator":"FDA"},{"date":"1997-01-07","orphan":false,"company":"","regulator":"EMA"}],"brandName":"Orlaam","ecosystem":[{"indication":"Opioid dependence","otherDrugs":[{"name":"buprenorphine","slug":"buprenorphine","company":"Reckitt Benckiser"},{"name":"naloxone","slug":"naloxone","company":"Adapt"}],"globalPrevalence":null}],"mechanism":{"target":"Potassium voltage-gated channel subfamily H member 2","novelty":"Follow-on","targets":[{"gene":"KCNH2","source":"DrugCentral","target":"Potassium voltage-gated channel subfamily H member 2","protein":"Potassium voltage-gated channel subfamily H member 2"},{"gene":"OPRM1","source":"DrugCentral","target":"Mu-type opioid receptor","protein":"Mu-type opioid receptor"}],"modality":"Small Molecule","drugClass":"High Risk QT Prolonging Agents","explanation":"","oneSentence":"","technicalDetail":"Orlaam (Levomethadyl Acetate) acts as a non-selective antagonist of the potassium voltage-gated channel subfamily H member 2 (hKv11.1), a critical component of the delayed rectifier potassium current (IKr) in the heart, which can lead to QT interval prolongation."},"commercial":{"launchDate":"1993","_launchSource":"DrugCentral (FDA 1993-07-09, ROXANE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/1571","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=LEVOMETHADYL%20ACETATE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=LEVOMETHADYL ACETATE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_emaChecked":true,"_enrichedAt":"2026-03-30T14:59:49.774819","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:41:58.063290+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"buprenorphine","drugSlug":"buprenorphine","fdaApproval":"1981-12-29","patentExpiry":"Sep 5, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"methadone","drugSlug":"methadone","fdaApproval":"1947-08-13","genericCount":13,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"lofexidine","drugSlug":"lofexidine","fdaApproval":"2018-05-16","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-class"}],"genericName":"levomethadyl acetate","indications":{"approved":[{"name":"Opioid dependence","source":"DrugCentral","snomedId":75544000,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Roxane","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"buprenorphine","brandName":"buprenorphine","genericName":"buprenorphine","approvalYear":"1981","relationship":"same-class"},{"drugId":"methadone","brandName":"methadone","genericName":"methadone","approvalYear":"1947","relationship":"same-class"},{"drugId":"lofexidine","brandName":"lofexidine","genericName":"lofexidine","approvalYear":"2018","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT00580827","phase":"NA","title":"Clinical Efficacy of Disulfiram in LAAM-Maintained Cocaine Abusers","status":"COMPLETED","sponsor":"Yale University","startDate":"2003-09","conditions":["Cocaine-Related Disorder","Opiate Dependence"],"enrollment":126,"completionDate":""},{"nctId":"NCT01935830","phase":"EARLY_PHASE1","title":"LAAM-HAART PET Imaging","status":"COMPLETED","sponsor":"Washington University School of Medicine","startDate":"2013-08","conditions":["Healthy Volunteers"],"enrollment":10,"completionDate":"2015-09"},{"nctId":"NCT00000300","phase":"PHASE4","title":"Feasibility Study of Take-Home LAAM Medication - 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