AMINOSYN-PF 10%
LOE Approachingisoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine
NDAINJECTIONINJECTABLE
Approved
Oct 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
AMINOSYN-PF 10% (isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, glycine, histidine, proline, serine, taurine, and tyrosine) by Otsuka is clinical pharmacology aminosyn-pf 10%, sulfite-free, (an amino acid injection — pediatric formula) contains a mixture of essential and nonessential amino acids as well as taurine. Approved for nitrogen, weight loss, treat negative nitrogen balance in infants and 3 more indications. First approved in 1986.
Drug data last refreshed 6h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMINOSYN-PF 10% is a pediatric-specific amino acid injection containing 18 essential and nonessential amino acids plus taurine, designed to mimic breast-fed infant plasma amino acid profiles. It provides total parenteral nutrition (TPN) support for infants and young children unable to receive adequate nutrition via enteral routes. When combined with cysteine hydrochloride, dextrose, electrolytes, vitamins, and minerals, it supplies complete nutritional support except essential fatty acids.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating portfolio defense and potential team restructuring opportunities.
Mechanism of Action
CLINICAL PHARMACOLOGY Aminosyn-PF 10%, Sulfite-Free, (an amino acid injection — pediatric formula) contains a mixture of essential and nonessential amino acids as well as taurine. The amino acid composition has been specifically formulated to provide a well-tolerated nitrogen source for nutritional…
Pharmacologic Class:
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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.