COLYTE
LOE Approachingpolyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous
NDAORALFOR SOLUTION
Approved
Oct 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
COLYTE (polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate anhydrous) by Gen Pharmaceuticals is 3350 which causes water to be retained in the colon and produces a watery stool. First approved in 1984.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COLYTE is an oral bowel preparation solution containing polyethylene glycol 3350 and electrolytes designed to cleanse the colon prior to colonoscopy or other GI procedures. It works by retaining water in the colon to produce a watery stool that evacuates intestinal contents. This is a standard-of-care preparation agent used across gastroenterology practices.
LOE Approaching
With LOE approaching and moderate competitive pressure (30%), brand team will shift from market expansion to generic transition management and potential lifecycle extensions or reformulation opportunities.
Mechanism of Action
3350 which causes water to be retained in the colon and produces a watery stool
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on COLYTE offers exposure to mature product lifecycle management, generic transition strategy, and payer negotiations in a commoditized therapeutic area. This role is best suited for professionals seeking experience in brand defense, cost-containment strategies, and operational efficiency rather than growth-stage innovation.
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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.