NDAINJECTIONINJECTABLE
Approved
Oct 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
CYSTEINE HYDROCHLORIDE (cysteine hydrochloride) by Pfizer is enzyme, cystathionase, via the trans-sulfuration pathway, and serves as a precursor substrate for both glutathione and taurine. First approved in 1986.
Drug data last refreshed 26m ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cysteine Hydrochloride is an amino acid injection approved in 1986 for neonatal parenteral nutrition support. It supplies cysteine to neonates who cannot synthesize adequate quantities due to deficient cystathionase enzyme activity. The drug works by providing substrate for glutathione and taurine synthesis via the trans-sulfuration pathway.
LOE Approaching
Product approaching loss of exclusivity with limited market visibility; likely small, stable team focused on niche neonatal hospital channel.
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 Cysteine Hydrochloride offers experience in niche hospital-based therapeutics and parenteral nutrition channels. The approaching LOE creates urgency around competitive positioning, formulary management, and cost-containment strategies rather than growth expansion.
Hospital Account 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.