NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Apr 2019
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
4/8 — Partial
Priority Review
ELCYS (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 43m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELCYS (cysteine hydrochloride) is an intravenous amino acid supplement for parenteral nutrition that provides exogenous cysteine to patients who cannot synthesize adequate quantities due to cystathionase deficiency or insufficiency. It works by serving as a precursor substrate for glutathione and taurine synthesis via the trans-sulfuration pathway. The drug addresses a critical metabolic gap in specialized nutrition support.
Peak12.2 years to LOE
ELCYS is in peak lifecycle stage with strong patent protection extending to 2039, indicating a stable, mature franchise with limited near-term commercial pressure but modest team expansion opportunities.
Mechanism of Action
enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. ELCYS provides cysteine to the systemic circulation of patients who require PN and cannot synthesize adequate quantities of cysteine due to insufficient or deficient…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
ELCYS is a niche specialty product with limited current job openings (0 linked roles), reflecting its narrow indication and mature market status. Career opportunities are concentrated in medical affairs, specialty sales, and hospital system management rather than high-growth commercial expansion.
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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.