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 18h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PRIMAXIN is an intravenous combination antibiotic containing imipenem (a broad-spectrum penem) and cilastatin (a renal dehydropeptidase inhibitor that prevents imipenem metabolism). It treats serious infections across respiratory, urinary, intra-abdominal, gynecologic, bone/joint, skin, and septicemia indications caused by susceptible gram-positive, gram-negative, and anaerobic bacteria. The cilastatin component preserves imipenem levels in the bloodstream by blocking its renal degradation, enhancing efficacy.
$0.022BPart D
LOE ApproachingDeclining
With LOE approaching and only $22K in Part D spending, the PRIMAXIN brand team is in consolidation mode; expect focus on managed care contracts and cost defense rather than growth initiatives.
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.
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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.