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MUCOMYST

NDA

ACETYLCYSTEINE | N013601 | APOTHECON INC DIV BRISTOL MYERS SQUIBB

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

3 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Dsquare LLC FDA-2024-P-2955 · 6 docket documents Dsquare LLC filed a citizen petition under 21 CFR 10.30 requesting that the FDA require sodium-containing N-Acetylcysteine products marketed for acetaminophen intoxication treatment include warnings about high sodium content in patient information and a Black Box Warning for salt-sensitive individua	505(q)	2024-06-21	Open	Dsquare LLC
Cumberland Pharmaceutical Inc. (Covington & Burling) - Citizen Petition FDA-2012-P-0507 · 5 docket documents Cumberland Pharmaceuticals Inc. submitted a citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA not approve any ANDA for acetylcysteine injection that contains edetate disodium (EDTA) as a component, since Cumberland's NDA-approved ACETADOTE bran	505(q)	2012-05-23	Partially Denied	—
Leydig, Voit & Mayer, LTD - Citizen Petition FDA-2011-P-0339 · 5 docket documents The law firm Leydig, Voit & Mayer filed this citizen petition on behalf of a client requesting that the FDA determine the discontinued original formulation of Acetadote (acetylcysteine) Injection NDA 21-539, which contained disodium edetate, was not withdrawn for safety or efficacy reasons, thereby	505(q)	2011-05-17	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

224 trials from ClinicalTrials.gov — 2 recruiting, 4 active, 159 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Systemic Lupus Erythematosus (SLE) With N-acetylcysteine NCT00775476	Phase 2	Active	State University of New York - Upstate Medical University	290	2022-05-05 → 2028-09-30
A Study of N-acetylcysteine in Patients With COVID-19 Infection NCT04374461	Phase 2	Active	Memorial Sloan Kettering Cancer Center	48	2020-05-01 → 2027-05
Glutathione in Mild Cognitive Impairment NCT03493178	Early Phase 1	Active	Baylor College of Medicine	60	2018-04-19 → 2026-12-31
Amiodarone and N-Acetylcysteine or Amiodarone Alone for Preventing Atrial Fibrillation After Thoracic Surgery NCT02750319	Phase 3	Active	Memorial Sloan Kettering Cancer Center	184	2016-04 → 2027-04
Pilon Fracture With Intra-articular Injection of N-Acetylcysteine (Pilon NAC)NCT03652753	Phase 4	Recruiting	University of Missouri-Columbia	30	2019-01-01 → 2026-12
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose NCT04278898	Phase 2	Recruiting	Stanford University	24	2021-02-12 → 2029-01-31
N-acetylcysteine to Reduce Ischemia/Reperfusion Injury in Liver Resection NCT01223326	Phase 4	Completed	Clinica Universidad de Navarra, Universidad de Navarra	46	2003-01 → 2007-12
Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers NCT01015209	Phase 1	Completed	Medical University of Vienna	30	2010-09 → 2011-01
ROS Signaling in Endothelial Function NCT01037465	N/A	Completed	Boston University	72	2008-09 → 2016-03-26
Homocystinuria: Treatment With N-Acetylcysteine NCT00483314	Phase 2	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	5	2007-11 → 2009-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain7 active DMFs

7 active API suppliers hold Drug Master Files for this ingredient.

FIS FABBRICA ITALIANA SINTETICI SPAACETYLCYSTEINE, USP

DMF 50911983

MOEHS IBERICA SLACETYLCYSTEINE USP

DMF 143041999

NIPPON RIKA CO LTDACETYLCYSTEINE DRUG SUBSTANCE

DMF 217892008

FUJIAN SOUTH PHARMACEUTICAL CO LTDACETYLCYSTEINE

DMF 379472023

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDACETYLCYSTEINE (USP)

DMF 402482024

SHANXI YANGHE PHARMACEUTICAL CO LTDACETYLCYSTEINE

DMF 415912025

ZHEJIANG HAIZHOU PHARMACEUTICAL CO LTDACETYLCYSTEINE

DMF 428222025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (2)

Sort:

#001 — 20% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INHALATION, ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION;INHALATION, ORAL | Approved: Approved Prior to Jan 1, 1982