IV N-acetylcysteine — Competitive Intelligence Brief

IV N-acetylcysteine (IV N-acetylcysteine) competitive landscape: 3 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antioxidant / Mucolytic agent. Area: Critical Care / Toxicology / Respiratory.

phase 3 Antioxidant / Mucolytic agent Glutathione synthesis pathway; free radical scavenger Critical Care / Toxicology / Respiratory Small molecule

Target snapshot

IV N-acetylcysteine (IV N-acetylcysteine) — Medical University of South Carolina. IV N-acetylcysteine replenishes intracellular glutathione and acts as a free radical scavenger to reduce oxidative stress and inflammation.

Comparator set (3 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
IV N-acetylcysteine TARGET	IV N-acetylcysteine	Medical University of South Carolina	phase 3	Antioxidant / Mucolytic agent	Glutathione synthesis pathway; free radical scavenger
N-Acetyl Cysteine (NAC)	N-Acetyl Cysteine (NAC)	The Aurum Institute NPC	marketed	Antioxidant / Mucolytic agent	Glutathione synthesis pathway; reactive oxygen species (non-specific)
Inhaled Reduced Glutathione	Inhaled Reduced Glutathione	Serafino A. Marsico	phase 3	Antioxidant / Mucolytic agent	Glutathione (endogenous antioxidant system)
IV N-Acetyl Cystein	IV N-Acetyl Cystein	Imam Khomeini Hospital	phase 3	Antioxidant / Mucolytic agent	Glutathione synthesis pathway; free radicals and reactive oxygen species

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Antioxidant / Mucolytic agent class)

1. Imam Khomeini Hospital · 1 drug in this class
2. Medical University of South Carolina · 1 drug in this class
3. Serafino A. Marsico · 1 drug in this class
4. The Aurum Institute NPC · 1 drug in this class