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  1. pharmadog
  2. ›drugs
  3. ›ACETYLCYSTEINE
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ACETYLCYSTEINE

Marketedupdated 3mo ago
by Xellia Pharmaceuticals USA LLC
Approved
community read0 votes

🐶 often sniffed alongside

top 5
  • tagApproval4 co-mentions · 2 sources
  • tagOphthalmology2 co-mentions · 1 sources
  • tagSmall Molecule2 co-mentions · 2 sources
  • companyMassachusetts Eye and Ear Infirmary1 co-mentions · 1 sources
  • drugN-acetylcysteine1 co-mentions · 1 sources

indications

investigational
COPD

all catalysts(2)

approval · 2
Feb 12, 2025
approval
2y ago
ACETYLCYSTEINE — FDA approval
ACETYLCYSTEINE
→
Sep 26, 2025
approval
11mo ago
ACETYLCYSTEINE — FDA approval
ACETYLCYSTEINE
→

Trials studying ACETYLCYSTEINE

  • phase2PK and PD Study of NPI-001 and Cysteamine Bitartraterecruitingn=12
  • phase324-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndromenot yet recruitingn=80
  • phase2Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdoseterminatedn=29
  • phase3A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretionscompletedn=333
  • phase2N-Acetylcysteine to Prevent Radiocontrast Nephropathy in Emergency Department Patientscompletedn=399
  • phase3Efficacy and Safety of the Combination of Acetylcysteine, Paracetamol and Phenylephrine for the Treatment of Common Coldwithdrawn
  • N/ALiveSpo Navax® Supports the Treatment of Acute Rhinosinusitis and Otitis Mediacompletedn=175

Patent cliff

source: FDA Orange Book
first barrier falls
Nov 26, 2027
~1.3 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (9)

  • May 8, 2032formulationUS 8747894
  • May 8, 2032formulationUS 8747894
  • May 8, 2032formulationUS 9427421
  • May 8, 2032formulationUS 9427421
  • May 8, 2032method-of-use (U-1373)US 9561204
  • May 8, 2032method-of-use (U-1373)US 9561204
  • Apr 6, 2032method-of-use (U-1373)US 8722738
  • Jul 21, 2031method-of-use (U-1839)US 93270284.9y
  • May 21, 2026formulationUS 8148356

FDA exclusivities (1)

  • Nov 26, 2027D-196New Indication (3y)1.3y

News(1)

  • Opinion: Why alternative medicine can feel so much better than mainstream health care
    Modern medicine is about making people better — not necessarily making them feel good.
    stat · 3mo ago
brand
ACETYLCYSTEINE
generic
ACETYLCYSTEINE
indication
Drug Overdose
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 1m ago
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