BLAORALCAPSULE
Approved
Dec 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
COTAZYM (pancrelipase (amylase; lipase; protease)) by Merck & Co. is lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglycerides, glycerol, and free fatty acids, protein into peptides and amino acids, and starch into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas. Approved for exocrine pancreatic insufficiency in adult. First approved in 1996.
Drug data last refreshed 3h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
COTAZYM is an oral capsule containing pancrelipase (a blend of lipase, protease, and amylase enzymes) approved to treat exocrine pancreatic insufficiency in adults. It replaces missing digestive enzymes by breaking down fats, proteins, and starches in the small intestine, mimicking the function of a healthy pancreas. The drug restores nutrient absorption in patients who cannot produce sufficient endogenous pancreatic enzymes.
LOE Approaching
LOE-approaching status signals shrinking commercial footprint and reduced team expansion; roles focus on maintenance and generic transition planning.
Mechanism of Action
lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglycerides, glycerol, and free fatty acids, protein into peptides and amino acids, and starch into dextrins and short chain sugars such as maltose and maltriose in the duodenum and proximal small intestine, thereby acting…
Indications (1)
Why This Matters for Your Career
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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.