NDAINJECTIONINJECTABLE
Approved
Oct 1986
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — 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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cysteine Hydrochloride is a parenteral nutrition supplement providing cysteine to neonates who cannot synthesize adequate quantities due to deficient cystathionase activity. It works as a precursor substrate for glutathione and taurine synthesis via the trans-sulfuration pathway. This injectable amino acid is essential for neonatal development and metabolic function.
LOE Approaching
Approaching loss of exclusivity signals team right-sizing and focus shifting toward generic defense or product lifecycle extension strategies.
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.
Why This Matters for Your Career
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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.