OSMOPREP
LOE Approachingsodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
NDAORALTABLET
Approved
Mar 2006
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
1
Data completeness
4/8 — Partial
OSMOPREP (sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate) by Bausch Health is clinical pharmacology osmoprep tablets, a dosing regimen containing 48 grams of sodium phosphate (32 tablets), induces diarrhea, which effectively cleanses the entire colon. First approved in 2006.
Drug data last refreshed 15h ago · AI intelligence enriched 17h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OsmoPrep is an oral tablet formulation containing sodium phosphate salts (dibasic anhydrous and monobasic monohydrate) approved in 2006 for bowel cleansing prior to colonoscopy. It works through osmotic effect, drawing water into the colon to induce evacuation and cleanse the entire colon within 1–3 hours per dose. The product represents a well-established, non-absorbed small molecule laxative.
LOE Approaching1.7 years to LOE
Product is approaching loss of exclusivity in mid-2028, signaling contraction phase and likely reduction in commercial team size and investment.
Mechanism of Action
CLINICAL PHARMACOLOGY OsmoPrep Tablets, a dosing regimen containing 48 grams of sodium phosphate (32 tablets), induces diarrhea, which effectively cleanses the entire colon. Each administration has a purgative effect for approximately 1 to 3 hours. The primary mode of action is thought to be…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Safety and Efficacy of OsmoPrep® Tablets Versus HalfLytely® and Bisacodyl Tablet Bowel Prep Kit for Colon Cleansing
Started Sep 2011
2,154 enrolled
Colon Cleansing
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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.