{"id":"doripenem","rwe":[{"pmid":"41858919","year":"2026","title":"In vitro Screening for Synergistic Polymyxin B-Based Combinations Against KPC- Producing Carbapenem-Resistant Klebsiella pneumoniae.","finding":"","journal":"Drug design, development and therapy","studyType":"Clinical Study"},{"pmid":"41807528","year":"2026","title":"Adsorption of doripenem and meropenem antibiotics on activated carbon derived from snake fruit seeds: single-compound and binary mechanism via experiments and modelling.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41718700","year":"2026","title":"A pharmacovigilance analysis of carbapenem-related utilizing the FDA adverse event reporting system (FAERS) database from 2013 to 2025.","finding":"","journal":"The Journal of antimicrobial chemotherapy","studyType":"Clinical Study"},{"pmid":"41586323","year":"2026","title":"Association between antimicrobial use and the detection rates of carbapenem-resistant Enterobacterales: long-term surveillance results from a single centre.","finding":"","journal":"Infection prevention in practice","studyType":"Clinical Study"},{"pmid":"41161476","year":"2025","title":"Development of two methods for detecting Streptococcus mitis/oralis-related species with meropenem-non-susceptibility.","finding":"","journal":"Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy","studyType":"Clinical Study"}],"tags":[{"label":"Penem Antibacterial","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"J01DH04","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Abdominal abscess","category":"indication"},{"label":"Cholecystitis","category":"indication"},{"label":"Complicated Urinary Tract Infections","category":"indication"},{"label":"Complicated appendicitis","category":"indication"},{"label":"Infectious disease of abdomen","category":"indication"},{"label":"Pyelonephritis","category":"indication"},{"label":"Shionogi Inc","category":"company"},{"label":"Approved 2000s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"drugInteractions":[{"url":"/drug/valproic-acid","drug":"valproic acid","action":"Avoid combination","effect":"May interact with Valproic Acid","source":"DrugCentral","drugSlug":"valproic-acid"}],"contraindications":["Impaired renal function disorder","Pseudomembranous enterocolitis"]},"trials":[],"aliases":[],"company":"Shionogi","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DORIPENEM","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:09:11.796980+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:09:19.008270+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DORIPENEM","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:09:19.717880+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Bacterial penicillin-binding protein inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:09:20.297255+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL491571/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:09:20.197634+00:00"}},"allNames":"doribax","offLabel":[],"synonyms":["doribax","doripenem","doripenem hydrate"],"timeline":[{"date":"2007-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from SHIONOGI INC to Shionogi Inc"},{"date":"2007-10-12","type":"positive","source":"DrugCentral","milestone":"FDA approval (Shionogi Inc)"}],"approvals":[{"date":"2007-10-12","orphan":false,"company":"SHIONOGI INC","regulator":"FDA"}],"brandName":"Doribax","ecosystem":[{"indication":"Abdominal abscess","otherDrugs":[{"name":"cefoxitin","slug":"cefoxitin","company":""},{"name":"ceftolozane","slug":"ceftolozane","company":"Cubist Pharms"},{"name":"cilastatin","slug":"cilastatin","company":"Merck"},{"name":"ciprofloxacin","slug":"ciprofloxacin","company":"Bayer Hlthcare"}],"globalPrevalence":89000},{"indication":"Cholecystitis","otherDrugs":[{"name":"ceftolozane","slug":"ceftolozane","company":"Cubist Pharms"},{"name":"tazobactam","slug":"tazobactam","company":""}],"globalPrevalence":null},{"indication":"Complicated Urinary Tract Infections","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"cefepime","slug":"cefepime","company":"Hospira Inc"},{"name":"gentamicin","slug":"gentamicin","company":"Schering"},{"name":"levofloxacin","slug":"levofloxacin","company":"Janssen Pharms"}],"globalPrevalence":null},{"indication":"Complicated appendicitis","otherDrugs":[{"name":"meropenem","slug":"meropenem","company":"Astrazeneca"},{"name":"tigecycline","slug":"tigecycline","company":"Pf Prism Cv"}],"globalPrevalence":null},{"indication":"Infectious disease of abdomen","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"}],"globalPrevalence":null},{"indication":"Pyelonephritis","otherDrugs":[{"name":"avibactam","slug":"avibactam","company":"Cerexa Inc"},{"name":"cefiderocol","slug":"cefiderocol","company":"Shionogi Inc"},{"name":"levofloxacin","slug":"levofloxacin","company":"Janssen Pharms"},{"name":"norfloxacin","slug":"norfloxacin","company":""}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","drugClass":"Penem Antibacterial","explanation":"","oneSentence":"","technicalDetail":"Doribax exerts its antibacterial effects by inhibiting the enzyme penicillin-binding protein 3 (PBP3), which is essential for bacterial cell wall synthesis and cross-linking."},"commercial":{"launchDate":"2007","_launchSource":"DrugCentral (FDA 2007-10-12, SHIONOGI INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4149","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DORIPENEM","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DORIPENEM","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":"2026-03-30T10:46:01.958426","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:09:22.068128+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"meropenem","drugSlug":"meropenem","fdaApproval":"1996-06-21","genericCount":12,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ertapenem","drugSlug":"ertapenem","fdaApproval":"2001-11-21","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"cilastatin","drugSlug":"cilastatin","fdaApproval":"1985-11-26","relationship":"same-class"},{"drugName":"imipenem","drugSlug":"imipenem","fdaApproval":"1985-11-26","relationship":"same-class"},{"drugName":"vaborbactam","drugSlug":"vaborbactam","fdaApproval":"2017-08-29","relationship":"same-class"},{"drugName":"relebactam","drugSlug":"relebactam","fdaApproval":"2019-06-16","relationship":"same-class"}],"genericName":"doripenem","indications":{"approved":[{"name":"Abdominal abscess","source":"DrugCentral","snomedId":75100008,"regulator":"FDA","usPrevalence":null,"globalPrevalence":89000,"prevalenceMethod":"curated","prevalenceSource":"Lancet Infect Dis, 2019 (PMID:31285144)"},{"name":"Cholecystitis","source":"DrugCentral","snomedId":76581006,"regulator":"FDA"},{"name":"Complicated Urinary Tract Infections","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Complicated appendicitis","source":"DrugCentral","snomedId":418171008,"regulator":"FDA"},{"name":"Infectious disease of abdomen","source":"DrugCentral","snomedId":128070006,"regulator":"FDA"},{"name":"Pyelonephritis","source":"DrugCentral","snomedId":45816000,"regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Shionogi Inc","drugCategory":"active","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"meropenem","brandName":"meropenem","genericName":"meropenem","approvalYear":"1996","relationship":"same-class"},{"drugId":"ertapenem","brandName":"ertapenem","genericName":"ertapenem","approvalYear":"2001","relationship":"same-class"},{"drugId":"cilastatin","brandName":"cilastatin","genericName":"cilastatin","approvalYear":"1985","relationship":"same-class"},{"drugId":"imipenem","brandName":"imipenem","genericName":"imipenem","approvalYear":"1985","relationship":"same-class"},{"drugId":"vaborbactam","brandName":"vaborbactam","genericName":"vaborbactam","approvalYear":"2017","relationship":"same-class"},{"drugId":"relebactam","brandName":"relebactam","genericName":"relebactam","approvalYear":"2019","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT01543334","phase":"","title":"Antibiotic Concentrations Among Critically Ill Patients","status":"COMPLETED","sponsor":"Centre Hospitalier Universitaire de Nīmes","startDate":"2012-03","conditions":["Administration of Antibiotics in Intensive Care Units"],"enrollment":98,"completionDate":"2012-04-01"},{"nctId":"NCT00986102","phase":"PHASE4","title":"PROUD Study: A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2009-07-17","conditions":["Pneumonia","Pneumonia, Ventilator-Associated","Urinary Tract Infections"],"enrollment":216,"completionDate":"2011-09-09"},{"nctId":"NCT02134106","phase":"PHASE2,PHASE3","title":"Randomized-controlled Trial (RCT) on Combination Antibiotic for Infections Caused by Gram-negative Bacteria","status":"WITHDRAWN","sponsor":"Tan Tock Seng Hospital","startDate":"2015-01","conditions":["Bacteremia","Healthcare-associated Pneumonia","Ventilator-associated Pneumonia"],"enrollment":0,"completionDate":"2015-12"},{"nctId":"NCT00515034","phase":"PHASE2","title":"A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2007-10","conditions":["Pneumonia, Ventilator-Associated","Pneumonia, Bacterial","Pneumonia","Abdominal Abscess","Bacterial Infections"],"enrollment":146,"completionDate":"2008-11"},{"nctId":"NCT01599806","phase":"PHASE3","title":"Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-10","conditions":["Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis"],"enrollment":641,"completionDate":"2014-08"},{"nctId":"NCT01595438","phase":"PHASE3","title":"Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-10","conditions":["Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis"],"enrollment":598,"completionDate":"2014-08"},{"nctId":"NCT01414959","phase":"","title":"Target Site Pharmacokinetics of Doripenem at Steady State in Intubated Intensive Care Patients","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2011-08","conditions":["Pneumonia","Abdominal Infection","Urinary Tract Infection"],"enrollment":16,"completionDate":"2013-07"},{"nctId":"NCT01517815","phase":"NA","title":"Pharmacokinetic of Doripenem and Piperacillin/Tazobactam in More Than 120 kg Critically Ill Patients","status":"COMPLETED","sponsor":"University Hospital, Montpellier","startDate":"2012-02","conditions":["Septic Shock"],"enrollment":50,"completionDate":"2013-06"},{"nctId":"NCT01797133","phase":"NA","title":"A Comparative Study of ID Fellow-based VS. Pharmacist-based Antibiotic Pre-authorization","status":"COMPLETED","sponsor":"Siriraj Hospital","startDate":"2013-02","conditions":["All Hospitalzied Patients","No Specific Conditions Requires"],"enrollment":984,"completionDate":"2013-12"},{"nctId":"NCT01401010","phase":"PHASE4","title":"Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients","status":"COMPLETED","sponsor":"Gary E. Stein, Pharm.D.","startDate":"2010-08","conditions":["Febrile Neutropenia"],"enrollment":12,"completionDate":"2012-02"},{"nctId":"NCT01110382","phase":"PHASE3","title":"A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections","status":"TERMINATED","sponsor":"Janssen Research & Development, LLC","startDate":"2010-12","conditions":["Abscess, Intra-Abdominal","Abdominal Abscess","Abdomen, Acute","Abdominal Pain","Appendicitis","Rupture","Infection","Intestinal Perforation","Peritonitis","Ileus"],"enrollment":41,"completionDate":"2013-09"},{"nctId":"NCT01110421","phase":"PHASE3","title":"A Safety and Tolerability Study of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia","status":"TERMINATED","sponsor":"Janssen Research & Development, LLC","startDate":"2010-12","conditions":["Pneumonia, Bacterial","Community-Acquired Infections","Nosocomial Infection","Pneumonia, Ventilator-Associated"],"enrollment":7,"completionDate":"2012-03"},{"nctId":"NCT01110408","phase":"PHASE3","title":"A Safety and Tolerability Study of Doripenem Compared With Cefepime in Children Hospitalized With Complicated Urinary Tract Infections","status":"TERMINATED","sponsor":"Janssen Research & Development, LLC","startDate":"2010-12","conditions":["Complicated Urinary Tract Infections or Pyelonephritis"],"enrollment":41,"completionDate":"2013-06"},{"nctId":"NCT02018939","phase":"PHASE3","title":"Multiple-dose Pharmacokinetics of Doripenem During Continuous Venovenous Hemodiafiltration and Molecular Adsorbent Recirculating System in ICU Patients and During Hemodialysis in Longterm Hemodialysis Patients.","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2010-03","conditions":["Infections During Organ Replacement Therapy"],"enrollment":24,"completionDate":"2014-02"},{"nctId":"NCT01281462","phase":"PHASE2","title":"Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2010-12","conditions":["Urinary Tract Infections"],"enrollment":217,"completionDate":"2012-07"},{"nctId":"NCT01027897","phase":"PHASE4","title":"Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients","status":"COMPLETED","sponsor":"Emory University","startDate":"2010-04","conditions":["Sepsis"],"enrollment":30,"completionDate":"2011-12"},{"nctId":"NCT01366651","phase":"PHASE1","title":"A Study of Doripenem in CerebrospinalFluid After Doripenem Administration in Pediatric Patients Less Than 1 Year of Age","status":"TERMINATED","sponsor":"Janssen Research & Development, LLC","startDate":"2012-03","conditions":["Meningitis"],"enrollment":1,"completionDate":"2012-06"},{"nctId":"NCT00965848","phase":"PHASE4","title":"A Safety and Efficacy Study of Doripenem in Participants With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Urinary Tract Infections","status":"COMPLETED","sponsor":"Janssen-Cilag Ltd.,Thailand","startDate":"2009-06","conditions":["Infection","Cross Infection","Bacterial Infections","Pneumonia, Ventilator-Associated","Intra-abdominal Infections","Urinary Tract Infections"],"enrollment":270,"completionDate":"2010-07"},{"nctId":"NCT00502801","phase":"PHASE2","title":"An Effectiveness, Safety, and Microbiology Study of Doripenem in Patients With Nosocomial (Hospital-acquired) Pneumonia","status":"COMPLETED","sponsor":"PriCara, Unit of Ortho-McNeil, Inc.","startDate":"2007-08","conditions":["Pneumonia","Bacterial Pneumonia","Ventilator-Associated Pneumonia","Infections, Nosocomial"],"enrollment":185,"completionDate":"2008-11"},{"nctId":"NCT01763008","phase":"","title":"A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections","status":"COMPLETED","sponsor":"Janssen Pharmaceutica","startDate":"2009-11","conditions":["Pneumonia, Bacterial","Nosocomial Infection","Intraabdominal Infections","Urinary Tract Infection"],"enrollment":170,"completionDate":"2012-11"},{"nctId":"NCT00925392","phase":"PHASE1","title":"Doripenem Intrapulmonary Pharmacokinetics in Healthy Adult Subjects","status":"COMPLETED","sponsor":"Keith A. Rodvold","startDate":"2009-06","conditions":["Healthy"],"enrollment":40,"completionDate":"2010-01"},{"nctId":"NCT01381848","phase":"PHASE1","title":"A Study of Doripenem in Infants Less Than 12 Weeks of Age","status":"COMPLETED","sponsor":"Janssen Research & Development, LLC","startDate":"2009-10","conditions":["Bacterial Infections"],"enrollment":52,"completionDate":"2012-04"},{"nctId":"NCT00589693","phase":"PHASE3","title":"To Compare Safety and Efficacy of Doripenem Versus Imipenem-Cilastatin in Patients With Ventilator-Associated Pneumonia","status":"TERMINATED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2008-04","conditions":["Ventilator-Associated Pneumonia"],"enrollment":274,"completionDate":"2011-06"},{"nctId":"NCT01467648","phase":"PHASE4","title":"The Pharmacodynamics of Doripenem Between 4-hour and 1-hour Infusion in Patients With Ventilator-associated Pneumonia","status":"COMPLETED","sponsor":"Sutep Jaruratanasirikul","startDate":"2010-10","conditions":["Ventilator-Associated Pneumonia"],"enrollment":12,"completionDate":"2011-10"},{"nctId":"NCT00211003","phase":"PHASE3","title":"Doripenem in the Treatment of Hospital-Acquired Pneumonia","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-05","conditions":["Pneumonia"],"enrollment":240,"completionDate":"2006-10"},{"nctId":"NCT00229060","phase":"PHASE3","title":"Doripenem in the Treatment of Complicated Intra-Abdominal Infections","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-03","conditions":["Bacterial Infections and Mycoses","Appendicitis","Cholecystitis","Pancreatitis","Peritonitis"],"enrollment":483,"completionDate":"2006-03"},{"nctId":"NCT00211016","phase":"PHASE3","title":"Doripenem in the Treatment of Ventilator-Associated Pneumonia","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-08","conditions":["Pneumonia","Ventilators, Mechanical"],"enrollment":318,"completionDate":"2006-10"},{"nctId":"NCT00229021","phase":"PHASE3","title":"Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2003-12","conditions":["Urinary Tract Infections","Pyelonephritis"],"enrollment":741,"completionDate":"2006-03"},{"nctId":"NCT00210938","phase":"PHASE3","title":"Doripenem in the Treatment of Complicated Intra-Abdominal Infections","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-03","conditions":["Bacterial Infections and Mycoses","Appendicitis","Cholecystitis","Pancreatitis","Peritonitis"],"enrollment":478,"completionDate":"2006-01"},{"nctId":"NCT00210990","phase":"PHASE3","title":"Doripenem in the Treatment of Complicated Lower Urinary Tract Infection or Pyelonephritis","status":"COMPLETED","sponsor":"Johnson & Johnson Pharmaceutical Research & Development, L.L.C.","startDate":"2004-03","conditions":["Urinary Tract Infections","Pyelonephritis"],"enrollment":403,"completionDate":"2006-04"},{"nctId":"NCT01311141","phase":"PHASE4","title":"Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers Dori_MD_1","status":"COMPLETED","sponsor":"Medical University of Vienna","startDate":"2010-08","conditions":["Healthy"],"enrollment":6,"completionDate":"2011-03"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_patentsChecked":true,"crossReferences":{"MMSL":"121413","NDDF":"012366","UNII":"BHV525JOBH","CHEBI":"CHEBI:135928","VANDF":"4026738","INN_ID":"7975","RXNORM":"119771","UMLSCUI":"C0389169","chemblId":"CHEMBL491571","ChEMBL_ID":"CHEMBL491571","KEGG_DRUG":"D01836","DRUGBANK_ID":"DB06211","PDB_CHEM_ID":" O6P","PUBCHEM_CID":"73303","SNOMEDCT_US":"428352004","IUPHAR_LIGAND_ID":"12183","MESH_DESCRIPTOR_UI":"D000077726"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2007-","companyName":"Shionogi Inc","relationship":"Original Developer"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"1.2 hours","clearance":"3.26 mL/min/kg","fractionUnbound":"0.92%","volumeOfDistribution":"0.23 L/kg"},"publicationCount":844,"therapeuticAreas":["Infectious Disease"],"atcClassification":{"source":"DrugCentral","atcCode":"J01DH04","allCodes":["J01DH04"]},"biosimilarFilings":[],"originalDeveloper":"Shionogi Inc","recentPublications":[{"date":"2026","pmid":"41858919","title":"In vitro Screening for Synergistic Polymyxin B-Based Combinations Against KPC- Producing Carbapenem-Resistant Klebsiella pneumoniae.","journal":"Drug design, development and therapy"},{"date":"2026 Mar 11","pmid":"41807528","title":"Adsorption of doripenem and meropenem antibiotics on activated carbon derived from snake fruit seeds: single-compound and binary mechanism via experiments and modelling.","journal":"Scientific reports"},{"date":"2026 Feb 2","pmid":"41718700","title":"A pharmacovigilance analysis of carbapenem-related utilizing the FDA adverse event reporting system (FAERS) database from 2013 to 2025.","journal":"The Journal of antimicrobial chemotherapy"},{"date":"2026 Mar","pmid":"41586323","title":"Association between antimicrobial use and the detection rates of carbapenem-resistant Enterobacterales: long-term surveillance results from a single centre.","journal":"Infection prevention in practice"},{"date":"2025 Dec","pmid":"41161476","title":"Development of two methods for detecting Streptococcus mitis/oralis-related species with meropenem-non-susceptibility.","journal":"Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy"}],"companionDiagnostics":[],"genericManufacturers":0,"_genericFilersChecked":true,"genericManufacturerList":[],"status":"approved","companyName":"Shionogi Inc","companyId":"shionogi","modality":"Small molecule","firstApprovalDate":"2007","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":"2007-10-12T00:00:00.000Z","mah":"SHIONOGI INC","brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":"2007-10-12T00:00:00.000Z","mah":"SHIONOGI INC","brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":"2007-10-12T00:00:00.000Z","mah":"SHIONOGI INC","brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":"2007-10-12T00:00:00.000Z","mah":"SHIONOGI INC","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":"2007-10-12T00:00:00.000Z","mah":"SHIONOGI INC","brand_name_local":null,"application_number":null},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2007-10-12T00:00:00.000Z","mah":"SHIONOGI INC","brand_name_local":null,"application_number":""},{"country_code":"AR","regulator":"ANMAT","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TR","regulator":"TITCK","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IN","regulator":"CDSCO","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TH","regulator":"FDA-TH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MY","regulator":"NPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"PH","regulator":"FDA-PH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CO","regulator":"INVIMA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"ZA","regulator":"SAHPRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"TW","regulator":"TFDA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"HK","regulator":"DH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"EU","regulator":"EMA","status":"withdrawn","approval_date":null,"mah":null,"brand_name_local":"Doribax","application_number":"EMEA/H/C/000891"},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":null,"brand_name_local":"Doribax","application_number":null},{"country_code":"BR","regulator":"ANVISA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"MX","regulator":"COFEPRIS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:09:22.068128+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}