{"id":"ceftobiprole-medocaril","rwe":[],"tags":[{"label":"ceftobiprole medocaril","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01DI01","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Infection of skin AND/OR subcutaneous tissue","category":"indication"},{"label":"Advanz Pharma","category":"company"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"}],"phase":"discontinued","safety":{},"trials":[],"aliases":["ceftobiprole"],"company":"Advanz","patents":[],"pricing":[],"allNames":"ro 65-5788","offLabel":[],"synonyms":["ceftobiprole medocaril","BAL5788","Ro 65-5788","ceftobiprole medocaril sodium","BAL9141","BAL-9141","BAL 9141","BAL 9141-000"],"timeline":[{"date":"2029-04-03","type":"negative","source":"FDA Orange Book","milestone":"New Chemical Entity exclusivity expires"},{"date":"2034-04-03","type":"negative","source":"FDA Orange Book","milestone":"GAIN exclusivity expires"}],"aiSummary":"Ceftobiprole medocaril is a small molecule antibiotic in the ceftobiprole class, originally developed by Advanz Pharma and currently owned by Istx. It is used to treat infections of the skin and/or subcutaneous tissue. Ceftobiprole medocaril is off-patent, meaning it is no longer protected by active patents. It is not clear if it has been approved by the FDA. As an off-patent medication, it may be available from generic manufacturers.","brandName":"Ro 65-5788","ecosystem":[{"indication":"Infection of skin AND/OR subcutaneous tissue","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"}],"globalPrevalence":null}],"mechanism":{"modality":"Small Molecule","drugClass":"ceftobiprole medocaril","explanation":"Imagine your body's cells are like buildings, and bacteria are like construction workers. Ceftobiprole medocaril stops the bacteria from building new walls around themselves, which is essential for their survival. Without these walls, the bacteria can't function properly and eventually die.","oneSentence":"Ceftobiprole medocaril works by inhibiting bacterial cell wall synthesis, ultimately leading to bacterial cell death.","technicalDetail":"Ceftobiprole medocaril exerts its antibacterial effect by binding to penicillin-binding proteins (PBPs) located inside the bacterial cell wall, thereby inhibiting the transpeptidation reaction that is essential for bacterial cell wall synthesis."},"commercial":{},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4402","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=Ceftobiprole%20medocaril","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Ceftobiprole medocaril","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"}],"_enrichedAt":"2026-03-30T09:20:07.540399","biosimilars":[],"competitors":[{"drugName":"ceftaroline fosamil","drugSlug":"ceftaroline-fosamil","fdaApproval":"2010-10-29","patentExpiry":"Sep 21, 2030","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"cefiderocol","drugSlug":"cefiderocol","fdaApproval":"2019-11-14","patentExpiry":"Sep 3, 2035","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"ceftolozane","drugSlug":"ceftolozane","fdaApproval":"2014-12-19","relationship":"same-class"}],"exclusivity":[{"code":"NCE","date":"Apr 3, 2029"},{"code":"GAIN","date":"Apr 3, 2034"}],"genericName":"ceftobiprole medocaril","indications":{"approved":[{"name":"Infection of skin AND/OR subcutaneous tissue","source":"DrugCentral","snomedId":19824006,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Istx","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"ceftaroline-fosamil","brandName":"ceftaroline fosamil","genericName":"ceftaroline fosamil","approvalYear":"2010","relationship":"same-class"},{"drugId":"cefiderocol","brandName":"cefiderocol","genericName":"cefiderocol","approvalYear":"2019","relationship":"same-class"},{"drugId":"ceftolozane","brandName":"ceftolozane","genericName":"ceftolozane","approvalYear":"2014","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07494981","phase":"","title":"Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations","status":"NOT_YET_RECRUITING","sponsor":"Chinese PLA General 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(EC)","status":"UNKNOWN","sponsor":"Azienda Sanitaria-Universitaria Integrata di Udine","startDate":"2019-10-01","conditions":["Therapeutic Drug Monitoring","Subarachnoid Hemorrhage","Intracerebral Hemorrhage"],"enrollment":104,"completionDate":"2021-10"},{"nctId":"NCT03317093","phase":"PHASE2","title":"Open and Exploratory Trial to Investigate the Pharmacokinetic of Ceftobiprole Medocaril in Patients With CSF Device","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire Dijon","startDate":"2018-03-29","conditions":["Inflamed Meninges","Suspected Meningitis","Ventriculitis"],"enrollment":5,"completionDate":"2019-11-04"},{"nctId":"NCT04409769","phase":"","title":"Evaluation of the Tolerance of Ceftaroline and Ceftobiprole in the Management of BJI / PJI","status":"COMPLETED","sponsor":"Hospices Civils de Lyon","startDate":"2020-02-01","conditions":["Bone and Joint Infection","Antibiotic 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