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Drug ReportsCilastatin
Primaxin, Recarbrio(cilastatin)
Cilastatin / Imipenem, Primaxin, Recarbrio (cilastatin) is a small molecule pharmaceutical. Cilastatin was first approved as Primaxin on 1985-11-26. It is used to treat bacterial endocarditis, infectious arthritis, infectious bone diseases, infectious skin diseases, and intraabdominal infections amongst others in the USA. It has been approved in Europe to treat gram-negative bacterial infections. The pharmaceutical is active against dipeptidase 1.
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FDA Novel Drug Approvals 2019
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
musculoskeletal diseasesD009140
respiratory tract diseasesD012140
urogenital diseasesD000091642
cardiovascular diseasesD002318
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Combinations
Imipenem cilastatin, Primaxin, Recarbrio (discontinued: Imipenem cilastatin, Primaxin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cilastatin sodium
+
Imipenem
Tradename
Company
Number
Date
Products
PRIMAXINMerck & CoN-050587 RX1985-11-26
1 products, RLD, RS
Show 2 discontinued
Cilastatin sodium
+
Imipenem
+
Relebactam
Tradename
Company
Number
Date
Products
RECARBRIOMerck & CoN-212819 RX2019-07-16
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
imipenem and cilastatinANDA2024-05-30
imipenem and cilastatin imipenem and cilastatinANDA2022-10-11
primaxinANDA, New Drug Application2024-07-05
recarbrioNew Drug Application2024-10-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
respiratory tract infections—D012141J06.9
urinary tract infectionsEFO_0003103D014552N39.0
bacterial infections—D001424A49
intraabdominal infections—D059413—
pseudomonas infectionsEFO_0001076D011552A41.52
enterobacteriaceae infectionsEFO_1001313D004756—
infectious skin diseases—D012874—
pelvic infection—D034161—
streptococcal infectionsEFO_1001476D013290—
staphylococcal infections—D013203A49.01
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Agency Specific
FDA
EMA
Expiration
Code
CILASTATIN SODIUM / IMIPENEM / RELEBACTAM, RECARBRIO, MSD MERCK CO
2029-07-16GAIN
2024-07-16NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Cilastatin Sodium / Imipenem / Relebactam, Recarbrio, Msd Merck Co
84870932029-11-19DS, DPU-2586, U-2587, U-2840
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01D: Other beta-lactam antibacterials in atc
— J01DH: Carbapenems
— J01DH51: Imipenem and cilastatin
— J01DH56: Imipenem, cilastatin and relebactam
HCPCS
Code
Description
J0742
Injection, imipenem 4 mg, cilastatin 4 mg and relebactam 2 mg
J0743
Injection, cilastatin sodium; imipenem, per 250 mg
Clinical
No data
Drug
General
Drug common nameCilastatin
INNcilastatin
Description
Cilastatin inhibits the human enzyme dehydropeptidase.
Classification
Small molecule
Drug classenzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC1(C)C[C@@H]1C(=O)N/C(=C\CCCCSC[C@H](N)C(=O)O)C(=O)O
Identifiers
PDB—
CAS-ID82009-34-5
RxCUI—
ChEMBL IDCHEMBL766
ChEBI ID3697
PubChem CID5280454
DrugBankDB01597
UNII ID141A6AMN38 (ChemIDplus, GSRS)
Target
Agency Approved
DPEP1
DPEP1
Organism
Homo sapiens
Gene name
DPEP1
Gene synonyms
MDP, RDP
NCBI Gene ID
1800
Protein name
dipeptidase 1
Protein synonyms
Beta-lactamase, Dehydropeptidase-I, dipeptidase 1 (renal), hRDP, Microsomal dipeptidase, Renal dipeptidase, testicular tissue protein Li 57
Uniprot ID
Q96AK2
Mouse ortholog
Dpep1 (13479)
dipeptidase 1 (P31428)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Primaxin – Merck & Co
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Estimated US medical usage
Cilastatin
+
Imipenem
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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