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ACETYLCYSTEINE · pharmadog

pharmadog
drugs
ACETYLCYSTEINE

drug

patient view →

ACETYLCYSTEINE

Marketedupdated 2mo ago

by Xellia Pharmaceuticals USA LLC

Approved

community read0 votes

indications

investigational

COPD

all catalysts(2)

approval · 2

ACETYLCYSTEINE — FDA approval

ACETYLCYSTEINE — FDA approval

News(0)

no news has mentioned this drug yet

brand

ACETYLCYSTEINE

generic

ACETYLCYSTEINE

indication

Drug Overdose

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 2h ago

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Tell Bork what looks wrong — wrong sponsor, stale phase, mislinked ticker, anything. We’ll triage and fix.

Patent cliff

source: FDA Orange Book

first barrier falls

Nov 26, 2027

~1.4 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 9327028
May 21, 2026formulationUS 8148356

FDA exclusivities (1)

Nov 26, 2027D-196New Indication (3y)1.4y

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🐶 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

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