imipenem ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
analogues of penicillanic acid antibiotics modified in the five-membered ring 1426 64221-86-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • imipenem
  • tienamycin
  • imipemide
  • imipenen
  • imipenem hydrate
Semisynthetic thienamycin that has a wide spectrum of antibacterial activity against gram-negative and gram-positive aerobic and anaerobic bacteria, including many multiresistant strains. It is stable to beta-lactamases. Clinical studies have demonstrated high efficacy in the treatment of infections of various body systems. Its effectiveness is enhanced when it is administered in combination with CILASTATIN, a renal dipeptidase inhibitor.
  • Molecular weight: 299.35
  • Formula: C12H17N3O4S
  • CLOGP: -0.39
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 4
  • TPSA: 113.72
  • ALOGS: -2.64
  • ROTB: 6

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
2 g P
2 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 10 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 69 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 222.82 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.24 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.86 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.95 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHUK,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,GRK3,GSK3B,IKBKB,ITK,JAK2,JAK3,KDR,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PIK3CA,PIK3CB,PIM2,PLK1,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,TTK 49
kinase-selectivity-class AXL,BRAF,CDK9,EIF2AK3,EPHB4,GRK2,MAP2K6,MAP3K14,MAPK7,PRKDC,STK33,TEK,TGFBR1 13
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
June 23, 2021 PMDA MSD K.K.
Feb. 13, 2020 EMA Merck Sharp & Dohme B.V.
Nov. 26, 1985 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug resistance 165.34 24.95 64 5412 30385 90592586
Seizure 124.86 24.95 90 5386 152539 90470432
Pathogen resistance 106.49 24.95 33 5443 8082 90614889
Multiple organ dysfunction syndrome 104.99 24.95 60 5416 68276 90554695
Septic shock 88.52 24.95 58 5418 84102 90538869
Clostridium difficile colitis 65.29 24.95 32 5444 26674 90596297
Ototoxicity 62.61 24.95 16 5460 1948 90621023
Renal failure 57.80 24.95 54 5422 130953 90492018
Geotrichum infection 57.36 24.95 12 5464 604 90622367
Sepsis 57.08 24.95 62 5414 179752 90443219
Hepatic infarction 56.07 24.95 12 5464 674 90622297
Aspergillus infection 56.04 24.95 22 5454 10801 90612170
Mycobacterium abscessus infection 55.97 24.95 13 5463 1062 90621909
Drug ineffective 53.99 24.95 194 5282 1384104 89238867
Respiratory failure 50.67 24.95 48 5428 118370 90504601
Acute kidney injury 47.59 24.95 76 5400 320311 90302660
Aplasia 47.22 24.95 15 5461 3976 90618995
Deafness 40.63 24.95 22 5454 22492 90600479
Electrocardiogram QT prolonged 40.15 24.95 34 5442 72422 90550549
Rash maculo-papular 40.07 24.95 27 5449 40906 90582065
Hepatotoxicity 39.60 24.95 28 5448 45814 90577157
Eosinophilic pneumonia acute 39.10 24.95 9 5467 706 90622265
Thrombocytopenia 37.30 24.95 54 5422 208671 90414300
Bone marrow failure 35.78 24.95 23 5453 32198 90590773
Drug reaction with eosinophilia and systemic symptoms 34.37 24.95 25 5451 42733 90580238
Pain 34.34 24.95 9 5467 996332 89626639
Enterococcal infection 33.81 24.95 15 5461 9976 90612995
Haemophagocytic lymphohistiocytosis 33.28 24.95 17 5459 15442 90607529
Candida infection 32.22 24.95 22 5454 34035 90588936
Heparin-induced thrombocytopenia 31.79 24.95 12 5464 5300 90617671
Granulomatosis with polyangiitis 31.76 24.95 10 5466 2575 90620396
Toxic epidermal necrolysis 30.74 24.95 21 5455 32507 90590464
Drug level below therapeutic 30.74 24.95 12 5464 5802 90617169
Pyrexia 30.26 24.95 98 5378 660387 89962584
Generalised tonic-clonic seizure 29.41 24.95 21 5455 34882 90588089
Pancytopenia 28.95 24.95 36 5440 120227 90502744
Bronchopulmonary aspergillosis 28.87 24.95 14 5462 11384 90611587
Eosinophilia 28.35 24.95 19 5457 28514 90594457
Type IV hypersensitivity reaction 27.66 24.95 10 5466 3916 90619055
Systemic candida 25.39 24.95 10 5466 4949 90618022
Fungaemia 25.36 24.95 9 5467 3341 90619630
Tooth discolouration 25.08 24.95 7 5469 1191 90621780

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 156.23 20.74 362 7925 629835 41983213
Drug resistance 154.05 20.74 91 8196 34157 42578891
Multiple organ dysfunction syndrome 127.12 20.74 123 8164 96912 42516136
Pathogen resistance 127.00 20.74 56 8231 11394 42601654
Septic shock 117.80 20.74 115 8172 91557 42521491
Ototoxicity 104.82 20.74 32 8255 2293 42610755
Eosinophilia 99.36 20.74 68 8219 32831 42580217
Thrombocytopenia 77.33 20.74 135 8152 190144 42422904
Pseudomonas infection 70.71 20.74 42 8245 15881 42597167
Brain abscess 64.33 20.74 26 8261 4258 42608790
Electrocardiogram QT prolonged 63.07 20.74 61 8226 47884 42565164
Hepatic cytolysis 61.62 20.74 47 8240 26797 42586251
Vascular pseudoaneurysm thrombosis 60.28 20.74 11 8276 76 42612972
Rash maculo-papular 59.55 20.74 53 8234 37450 42575598
Candida infection 56.69 20.74 41 8246 21569 42591479
Nocardiosis 56.29 20.74 25 8262 5165 42607883
Condition aggravated 54.42 20.74 141 8146 260613 42352435
Cardiac valve vegetation 49.74 20.74 13 8274 528 42612520
Seizure 49.47 20.74 86 8201 120475 42492573
Bronchopulmonary aspergillosis 49.00 20.74 36 8251 19393 42593655
Mycobacterium fortuitum infection 43.10 20.74 11 8276 406 42612642
Toxic epidermal necrolysis 42.84 20.74 38 8249 26712 42586336
Mycobacterial peritonitis 41.34 20.74 9 8278 164 42612884
Treatment failure 40.22 20.74 55 8232 62569 42550479
Geotrichum infection 39.56 20.74 11 8276 566 42612482
Botulism 39.11 20.74 9 8278 213 42612835
Drug ineffective for unapproved indication 38.23 20.74 46 8241 46117 42566931
Proteus test positive 37.42 20.74 9 8278 259 42612789
Acute respiratory distress syndrome 37.13 20.74 37 8250 30071 42582977
Haemoperitoneum 36.13 20.74 14 8273 2052 42610996
Fatigue 36.09 20.74 20 8267 435621 42177427
Drug reaction with eosinophilia and systemic symptoms 34.96 20.74 42 8245 42033 42571015
Embolic cerebral infarction 34.87 20.74 11 8276 878 42612170
Splenic candidiasis 34.73 20.74 7 8280 86 42612962
Fungaemia 33.66 20.74 15 8272 3121 42609927
Product use in unapproved indication 33.62 20.74 95 8192 184361 42428687
Hepatic haemorrhage 33.62 20.74 10 8277 655 42612393
Intestinal ulcer 32.79 20.74 11 8276 1066 42611982
Respiratory failure 32.72 20.74 75 8212 128057 42484991
Leukocytosis 32.09 20.74 34 8253 29674 42583374
Disseminated intravascular coagulation 31.56 20.74 31 8256 24763 42588285
Wound drainage 28.69 20.74 9 8278 705 42612343
Aspergillus infection 28.39 20.74 24 8263 15813 42597235
Deafness 27.95 20.74 22 8265 13118 42599930
Pyroglutamic acidosis 27.85 20.74 9 8278 776 42612272
Pain 27.29 20.74 7 8280 244841 42368207
Graft versus host disease 26.12 20.74 21 8266 12904 42600144
Clostridium difficile colitis 25.98 20.74 26 8261 21226 42591822
Acoustic neuroma 25.91 20.74 6 8281 146 42612902
Large intestine infection 25.54 20.74 11 8276 2110 42610938
Opisthotonus 25.51 20.74 8 8279 626 42612422
Enterococcal infection 25.27 20.74 20 8267 12019 42601029
Rash morbilliform 23.94 20.74 13 8274 4140 42608908
Functional gastrointestinal disorder 23.86 20.74 11 8276 2477 42610571
Vasculitis 23.41 20.74 23 8264 18371 42594677
Pulmonary physical examination abnormal 22.40 20.74 4 8283 24 42613024
Venoocclusive disease 21.86 20.74 12 8275 3903 42609145
Anuria 21.75 20.74 18 8269 11514 42601534
Benign soft tissue neoplasm 21.62 20.74 5 8282 121 42612927
Fusarium infection 21.51 20.74 9 8278 1607 42611441
Long QT syndrome 21.33 20.74 11 8276 3156 42609892
Ecthyma 21.04 20.74 7 8280 661 42612387
Shock 20.87 20.74 27 8260 29094 42583954
Bacterial toxaemia 20.85 20.74 5 8282 142 42612906
Pancytopenia 20.79 20.74 60 8227 117683 42495365
Arthralgia 20.79 20.74 7 8280 205231 42407817

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug resistance 268.92 20.98 131 12685 56243 110520240
Multiple organ dysfunction syndrome 248.01 20.98 176 12640 151534 110424949
Pathogen resistance 219.18 20.98 81 12735 17591 110558892
Drug ineffective 217.02 20.98 514 12302 1520026 109056457
Septic shock 206.36 20.98 160 12656 157368 110419115
Ototoxicity 137.56 20.98 40 12776 4091 110572392
Eosinophilia 135.18 20.98 84 12732 57852 110518631
Thrombocytopenia 118.15 20.98 172 12644 348713 110227770
Seizure 117.07 20.98 136 12680 221049 110355434
Electrocardiogram QT prolonged 105.58 20.98 93 12723 108867 110467616
Pseudomonas infection 95.85 20.98 52 12764 27801 110548682
Geotrichum infection 94.42 20.98 23 12793 1189 110575294
Rash maculo-papular 94.03 20.98 74 12742 74148 110502335
Nocardiosis 91.64 20.98 34 12782 7452 110569031
Candida infection 85.99 20.98 59 12757 47950 110528533
Respiratory failure 84.45 20.98 114 12702 215218 110361265
Bronchopulmonary aspergillosis 79.14 20.98 47 12769 29816 110546667
Clostridium difficile colitis 76.52 20.98 53 12763 43725 110532758
Toxic epidermal necrolysis 72.79 20.98 57 12759 56670 110519813
Aspergillus infection 72.31 20.98 42 12774 25574 110550909
Hepatic cytolysis 72.12 20.98 56 12760 54997 110521486
Sepsis 69.63 20.98 131 12685 327215 110249268
Pain 68.09 20.98 14 12802 954941 109621542
Brain abscess 65.81 20.98 26 12790 6748 110569735
Vascular pseudoaneurysm thrombosis 65.46 20.98 11 12805 80 110576403
Drug reaction with eosinophilia and systemic symptoms 63.83 20.98 62 12754 82033 110494450
Renal failure 61.54 20.98 101 12715 226473 110350010
Fatigue 59.02 20.98 34 12782 1215924 109360559
Leukocytosis 58.31 20.98 49 12767 53779 110522704
Acute respiratory distress syndrome 54.70 20.98 47 12769 53151 110523332
Enterococcal infection 53.82 20.98 32 12784 20334 110556149
Product use in unapproved indication 52.23 20.98 141 12675 447236 110129247
Mycobacterium fortuitum infection 52.06 20.98 12 12804 488 110575995
Mycobacterium abscessus infection 50.14 20.98 15 12801 1691 110574792
Cardiac valve vegetation 47.98 20.98 13 12803 1027 110575456
Pancytopenia 45.90 20.98 85 12731 209528 110366955
Deafness 45.88 20.98 32 12784 26677 110549806
Drug ineffective for unapproved indication 45.78 20.98 58 12758 102780 110473703
Arthralgia 45.16 20.98 17 12799 779615 109796868
Hepatic infarction 44.03 20.98 12 12804 969 110575514
Mycobacterial peritonitis 42.94 20.98 9 12807 234 110576249
Off label use 41.55 20.98 306 12510 1499879 109076604
Disseminated intravascular coagulation 41.48 20.98 36 12780 41250 110535233
Headache 39.53 20.98 27 12789 882350 109694133
Splenic candidiasis 38.20 20.98 7 12809 88 110576395
Systemic candida 38.19 20.98 20 12796 9954 110566529
Acute kidney injury 37.31 20.98 159 12657 635271 109941212
Intestinal ulcer 37.12 20.98 13 12803 2414 110574069
Treatment failure 37.06 20.98 92 12724 277142 110299341
Klebsiella infection 36.78 20.98 25 12791 19984 110556499
Generalised tonic-clonic seizure 36.44 20.98 38 12778 54642 110521841
Botulism 35.83 20.98 9 12807 528 110575955
Acinetobacter infection 35.71 20.98 14 12802 3559 110572924
Shock 35.28 20.98 37 12779 53551 110522932
Condition aggravated 35.08 20.98 173 12643 734663 109841820
Embolic cerebral infarction 34.76 20.98 11 12805 1495 110574988
Aspergillus test positive 34.22 20.98 10 12806 1040 110575443
Hepatotoxicity 33.49 20.98 39 12777 63361 110513122
Proteus test positive 32.87 20.98 9 12807 739 110575744
Abdominal discomfort 31.97 20.98 4 12812 393854 110182629
Fall 31.96 20.98 15 12801 603467 109973016
Hepatic haemorrhage 31.85 20.98 10 12806 1324 110575159
Nephropathy toxic 31.80 20.98 26 12790 27452 110549031
Graft versus host disease 31.06 20.98 22 12794 18784 110557699
Peripheral swelling 30.71 20.98 5 12811 404029 110172454
Haemoperitoneum 30.17 20.98 14 12802 5374 110571109
Eosinophilic pneumonia acute 29.68 20.98 10 12806 1655 110574828
Staphylococcal infection 28.85 20.98 38 12778 69906 110506577
Fungaemia 28.55 20.98 14 12802 6072 110570411
Weight increased 28.13 20.98 7 12809 419637 110156846
Wound drainage 27.94 20.98 9 12807 1295 110575188
Rash morbilliform 27.78 20.98 15 12801 7936 110568547
Agranulocytosis 27.74 20.98 35 12781 61725 110514758
Heparin-induced thrombocytopenia 27.73 20.98 17 12799 11407 110565076
Abscess 27.68 20.98 24 12792 27445 110549038
Pain in extremity 27.54 20.98 11 12805 487107 110089376
Pyrexia 27.50 20.98 188 12628 898077 109678406
Drug level below therapeutic 27.39 20.98 17 12799 11656 110564827
Gamma-glutamyltransferase increased 26.36 20.98 34 12782 61275 110515208
Bone marrow failure 26.33 20.98 33 12783 57815 110518668
Hepatic failure 26.30 20.98 36 12780 68703 110507780
Neutropenia 25.32 20.98 98 12718 374522 110201961
Dermatitis exfoliative 25.30 20.98 16 12800 11331 110565152
Aplasia 25.15 20.98 14 12802 7859 110568624
Acoustic neuroma 24.59 20.98 6 12810 312 110576171
Pulmonary physical examination abnormal 24.47 20.98 4 12812 24 110576459
Hepatic lesion 24.16 20.98 14 12802 8479 110568004
HIV infection 23.91 20.98 8 12808 1295 110575188
Pyroglutamic acidosis 23.88 20.98 9 12807 2059 110574424
Nasopharyngitis 23.82 20.98 8 12808 394353 110182130
Benign soft tissue neoplasm 23.78 20.98 5 12811 132 110576351
Mucormycosis 23.73 20.98 15 12801 10613 110565870
Moraxella infection 23.63 20.98 7 12809 763 110575720
Swelling 23.24 20.98 6 12810 351035 110225448
Encephalopathy 23.15 20.98 37 12779 81018 110495465
Arthropathy 23.13 20.98 3 12813 287519 110288964
Large intestine infection 23.08 20.98 11 12805 4481 110572002
Haemodynamic instability 23.07 20.98 20 12796 22868 110553615
Hypoproteinaemia 22.98 20.98 12 12804 5933 110570550
Functional gastrointestinal disorder 22.79 20.98 12 12804 6037 110570446
Bacterial toxaemia 22.59 20.98 5 12811 169 110576314
Granulomatosis with polyangiitis 22.49 20.98 10 12806 3480 110573003
Organ failure 22.35 20.98 11 12805 4806 110571677
Toxic skin eruption 21.78 20.98 21 12795 27494 110548989
Stevens-Johnson syndrome 21.73 20.98 27 12789 46874 110529609
Synovitis 21.72 20.98 3 12813 274089 110302394
Parasitic encephalitis 21.63 20.98 4 12812 53 110576430
Leukopenia 21.59 20.98 51 12765 148740 110427743
Back pain 21.59 20.98 8 12808 370988 110205495
Stomatitis 21.31 20.98 3 12813 270239 110306244
Dizziness 21.25 20.98 30 12786 698163 109878320
Haemodialysis 21.00 20.98 17 12799 17702 110558781

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J01DH51 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER BETA-LACTAM ANTIBACTERIALS
Carbapenems
ATC J01DH56 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
OTHER BETA-LACTAM ANTIBACTERIALS
Carbapenems
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000900 Anti-Bacterial Agents
CHEBI has role CHEBI:36047 antibacterial drug

Related Drugs by ATC class:

J01DH Carbapenems 10 drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Bacterial septicemia indication 10001005 DOID:0040085
Infection caused by Pseudomonas aeruginosa strain resistant to carbapenem antimicrobial drugs indication 11218009
Infection of skin AND/OR subcutaneous tissue indication 19824006
Pneumonia due to Streptococcus indication 34020007
Peritonitis indication 48661000
Lower respiratory tract infection indication 50417007
Pneumonia due to Escherichia coli indication 51530003
Bacterial pneumonia indication 53084003 DOID:874
Haemophilus influenzae pneumonia indication 70036007
Infection caused by Escherichia coli strain resistant to carbapenem antimicrobial drugs indication 71057007
Infection caused by Serratia spp resistant to carbapenem antimicrobial drugs indication 71120004
Abdominal abscess indication 75100008
Endometritis indication 78623009 DOID:1002
Infection of bone indication 111253001
Female genital tract infection indication 125585007
Infectious disease of abdomen indication 128070006
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Bacterial endocarditis indication 301183007
Bacterial urinary infection indication 312124009
Infectious disorder of joint indication 363162000
Infection caused by Enterococcus spp resistant to carbapenem antimicrobial drugs indication 406574007
Acute exacerbation of chronic bronchitis indication 425748003
Infection caused by Acinetobacter spp resistant to carbapenem antimicrobial drugs indication 840588006
Infection caused by Citrobacter spp resistant to carbapenem antimicrobial drugs indication 1137353009
Gram-Negative Aerobic Bacillary Pneumonia indication
Enterobacter Pneumonia indication
Diabetic Foot Infection indication
Inflammatory Disease of Female Pelvic Organs indication
Pyrexia of unknown origin off-label use 7520000
Inhalational anthrax off-label use 11389007
Cutaneous anthrax off-label use 84980006 DOID:7426
Gastrointestinal anthrax off-label use 111798006 DOID:13386
Infection by Campylobacter fetus off-label use 111835002
Gas gangrene caused by clostridium perfringens off-label use 266093005
Anthrax off-label use 409498004 DOID:7427
Melioidosis off-label use 428111003 DOID:5052
Pseudomonas Respiratory Tract Infection in Cystic Fibrosis off-label use
Clostridium Perfringens Empyema off-label use
Kidney disease contraindication 90708001 DOID:557
Seizure disorder contraindication 128613002
Lesion of brain contraindication 301766008
Pseudomembranous enterocolitis contraindication 397683000




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 2.9 acidic
pKa2 9.92 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL RECARBRIO MSD MERCK CO N212819 July 16, 2019 RX POWDER INTRAVENOUS 8487093 March 21, 2033 TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI)
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL RECARBRIO MSD MERCK CO N212819 July 16, 2019 RX POWDER INTRAVENOUS 8487093 March 21, 2033 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS, INCLUDING PYELONEPHRITIS (CUTI)
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL RECARBRIO MSD MERCK CO N212819 July 16, 2019 RX POWDER INTRAVENOUS 8487093 March 21, 2033 TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA (HABP/VABP)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL RECARBRIO MSD MERCK CO N212819 July 16, 2019 RX POWDER INTRAVENOUS July 16, 2024 NEW CHEMICAL ENTITY
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL RECARBRIO MSD MERCK CO N212819 July 16, 2019 RX POWDER INTRAVENOUS Dec. 9, 2028 NEW PATIENT POPULATION
EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL RECARBRIO MSD MERCK CO N212819 July 16, 2019 RX POWDER INTRAVENOUS July 16, 2029 GENERATING ANTIBIOTIC INCENTIVES NOW

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Bacterial penicillin-binding protein Enzyme INHIBITOR CHEMBL CHEMBL
Penicillin-binding protein 4 Enzyme IC50 7.30 WOMBAT-PK
Penicillin-binding protein 1 Enzyme IC50 7 WOMBAT-PK
Beta-lactamase Enzyme Ki 7.22 CHEMBL
Beta-lactamase GES-13 Enzyme IC50 6.82 CHEMBL

External reference:

IDSource
4017969 VUID
N0000146319 NUI
D00206 KEGG_DRUG
4017969 VANDF
C0020933 UMLSCUI
CHEBI:471744 CHEBI
ID1 PDB_CHEM_ID
CHEMBL43708 ChEMBL_ID
DB01598 DRUGBANK_ID
D015378 MESH_DESCRIPTOR_UI
104838 PUBCHEM_CID
10821 IUPHAR_LIGAND_ID
71OTZ9ZE0A UNII
5690 RXNORM
4869 MMSL
d04401 MMSL
002813 NDDF
424285002 SNOMEDCT_US
46558003 SNOMEDCT_US
74431-23-5 SECONDARY_CAS_RN
71OTZ9ZE0A INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PRIMAXINIV HUMAN PRESCRIPTION DRUG LABEL 2 0006-3514 INJECTION, POWDER, FOR SOLUTION 250 mg INTRAVENOUS NDA 25 sections
PRIMAXINIV HUMAN PRESCRIPTION DRUG LABEL 2 0006-3514 INJECTION, POWDER, FOR SOLUTION 250 mg INTRAVENOUS NDA 25 sections
PRIMAXINIV HUMAN PRESCRIPTION DRUG LABEL 2 0006-3516 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS NDA 25 sections
PRIMAXINIV HUMAN PRESCRIPTION DRUG LABEL 2 0006-3516 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS NDA 25 sections
PRIMAXINIV HUMAN PRESCRIPTION DRUG LABEL 2 0006-3551 INJECTION, POWDER, FOR SOLUTION 250 mg INTRAVENOUS ANDA 25 sections
PRIMAXINIV HUMAN PRESCRIPTION DRUG LABEL 2 0006-3551 INJECTION, POWDER, FOR SOLUTION 250 mg INTRAVENOUS ANDA 25 sections
PRIMAXINIV HUMAN PRESCRIPTION DRUG LABEL 2 0006-3552 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 25 sections
PRIMAXINIV HUMAN PRESCRIPTION DRUG LABEL 2 0006-3552 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 25 sections
Imipenem and Cilastatin HUMAN PRESCRIPTION DRUG LABEL 2 63323-322 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 25 sections
Imipenem and Cilastatin HUMAN PRESCRIPTION DRUG LABEL 2 63323-322 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 25 sections
Imipenem and Cilastatin HUMAN PRESCRIPTION DRUG LABEL 2 63323-322 INJECTION, POWDER, FOR SOLUTION 500 mg INTRAVENOUS ANDA 25 sections
Imipenem and Cilastatin HUMAN PRESCRIPTION DRUG LABEL 2 63323-349 INJECTION, POWDER, FOR SOLUTION 250 mg INTRAVENOUS ANDA 25 sections
Imipenem and Cilastatin HUMAN PRESCRIPTION DRUG LABEL 2 63323-349 INJECTION, POWDER, FOR SOLUTION 250 mg INTRAVENOUS ANDA 25 sections
Imipenem and Cilastatin HUMAN PRESCRIPTION DRUG LABEL 2 63323-349 INJECTION, POWDER, FOR SOLUTION 250 mg INTRAVENOUS ANDA 25 sections