NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Dec 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
3/8 — Basic
Priority Review
NOURESS (cysteine hydrochloride) by Baxter International is enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. First approved in 2019.
Drug data last refreshed 7h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NOURESS (cysteine hydrochloride) is an IV solution that provides essential cysteine to neonates requiring parenteral nutrition who cannot synthesize adequate quantities due to deficient cystathionase activity. It works by serving as a precursor substrate for glutathione and taurine synthesis via the trans-sulfuration pathway. This orphan/specialty neonatal nutrition product addresses a critical metabolic gap in premature and critically ill infants.
Peak12.6 years to LOE
Product is in peak commercial phase with established neonatal ICU penetration; team likely focused on maintaining market position and reimbursement optimization in a specialized, stable indication.
Mechanism of Action
enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. Cysteine hydrochloride injection, USP provides cysteine to the systemic circulation of neonates who require parenteral nutrition and cannot synthesize adequate quantities…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on NOURESS offers stability in a specialized, orphan-like indication with minimal competitive pressure and long patent protection through 2039. Career growth depends primarily on deepening neonatal ICU relationships, reimbursement expertise, and small-team agility rather than large-scale commercial scaling.
Brand Manager
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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.