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 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Cysteine hydrochloride is an injectable amino acid supplement provided to neonates requiring parenteral nutrition who cannot synthesize adequate cysteine due to deficient cystathionase enzyme activity. It works via the trans-sulfuration pathway to serve as a precursor substrate for glutathione and taurine synthesis, supporting essential metabolic functions.
LOE Approaching
This niche neonatal parenteral nutrition product faces upcoming patent expiration with limited commercial opportunity and likely small, specialized team.
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 stability in a mature, niche therapeutic area but limited growth or prestige given its LOE status and zero linked job openings. This role suits candidates seeking operational excellence and compliance-focused work in specialty pharmaceutical manufacturing rather than commercial expansion.
Product 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.