AMINOSYN-PF 7%
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
Sep 1985
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
AMINOSYN-PF 7% (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 7% 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 4 more indications. First approved in 1985.
Drug data last refreshed 4h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AMINOSYN-PF 7% is a pediatric amino acid injection containing 18 essential and nonessential amino acids plus taurine, specifically formulated to support total parenteral nutrition (TPN) in infants and young children. It provides nitrogen source and nutritional support for patients unable to receive adequate protein via oral, gastrostomy, or jejunostomy routes, or when gastrointestinal protein absorption is impaired. When combined with cysteine hydrochloride and dextrose, it approximates breast-fed infant plasma amino acid profiles and supports weight gain and nitrogen balance.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating potential team consolidation and shift toward cost management and hospital contracting roles.
Mechanism of Action
CLINICAL PHARMACOLOGY Aminosyn-PF 7% 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:
Worked on AMINOSYN-PF 7% at Otsuka? Share your interview experience or compensation data (+7 days Pro)
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.