NDAINTRAVENOUSPOWDERPriority Review
Approved
Nov 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
PRIMAXIN (imipenem and cilastatin sodium) by Merck & Co. is (i. Approved for the following serious infections caused by designated susceptible bacteria: lower respiratory tract infections, lower respiratory tract infections caused by susceptible strains of staphylococcus aureus (penicillinase-producing isolates), acinetobacter species and 37 more indications. First approved in 1985.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRIMAXIN is a fixed-dose intravenous combination of imipenem (a penem antibiotic) and cilastatin (a renal dehydropeptidase inhibitor) approved in 1985 for serious gram-positive, gram-negative, and anaerobic infections. Imipenem kills bacteria by inhibiting cell-wall synthesis, while cilastatin prevents imipenem degradation in the kidneys, enhancing efficacy. It is indicated for lower respiratory tract infections, urinary tract infections, intra-abdominal infections, gynecologic infections, bacterial septicemia, bone and joint infections, skin infections, and endocarditis.
$0.022MPart D
LOE ApproachingDeclining
This legacy product approaching loss of exclusivity has minimal Part D volume (54 claims, $22K spending in 2023), signaling a mature, stable but shrinking commercial footprint with limited team expansion opportunities.
Mechanism of Action
(I.V.) is a combination of imipenem and cilastatin. Imipenem is a penem antibacterial drug [see Microbiology ( )] . Cilastatin is a renal dehydropeptidase inhibitor that limits the renal metabolism of imipenem.
Worked on PRIMAXIN at Merck & Co.? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.