NDAINTRAVENOUSINJECTABLEPriority Review
Approved
Jan 2004
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
Priority Review
ACETADOTE (acetylcysteine) by Cumberland Pharmaceuticals is reduction activity [moa]. Approved for lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in adults, greater with acute ingestion, from repeated supratherapeutic ingestion (rsi) (). First approved in 2004.
Drug data last refreshed 2h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACETADOTE is an intravenous formulation of acetylcysteine, a small-molecule antidote approved for acetaminophen overdose. It reduces hepatic injury by replenishing glutathione stores and providing an alternate substrate for detoxification of the reactive acetaminophen metabolite. The drug is indicated for both acute ingestion and repeated supratherapeutic ingestion scenarios.
Peak5.5 years to LOE
Mature product with established market presence; commercial team likely stable with maintenance-focused strategies rather than growth investments.
Mechanism of Action
Reduction Activity
Pharmacologic Class:
Antidote
Worked on ACETADOTE at Cumberland Pharmaceuticals? Share your interview experience or compensation data (+7 days Pro)
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.