Acetylcysteine Patent Expiration

Acetylcysteine is Used for treating acetaminophen overdose with acetylcysteine solutions to provide a reduction in side effects for human patients. It was first introduced by Apothecon Inc Div Bristol Myers Squibb in its drug Mucomyst on Approved Prior to Jan 1, 1982. Other drugs containing Acetylcysteine are Acetadote, Cetylev. 19 different companies have introduced drugs containing Acetylcysteine.


Acetylcysteine Patents

Given below is the list of patents protecting Acetylcysteine, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Acetadote US8952065 Acetylcysteine composition and uses thereof Feb 10, 2035 Apotex
Cetylev US8747894 Effervescent compositions containing N-acetylcysteine May 08, 2032 Arbor Pharms Llc
Cetylev US9427421 Effervescent compositions containing N-acetylcysteine May 08, 2032 Arbor Pharms Llc
Cetylev US9561204 Effervescent compositions containing N-acetylcysteine May 08, 2032 Arbor Pharms Llc
Acetadote US8722738 Acetycysteine compositions and methods of use thereof Apr 06, 2032 Apotex
Acetadote US9327028 Acetylcysteine compositions and methods of use thereof Jul 21, 2031 Apotex
Acetadote US8148356 Acetylcysteine composition and uses therefor May 21, 2026

(Expired)

Apotex
Acetadote US8399445 Acetylcysteine composition and uses thereof Aug 24, 2025

(Expired)

Apotex
Acetadote US8653061 Acetylcysteine composition and uses thereof Aug 24, 2025

(Expired)

Apotex



Acetylcysteine's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Acetylcysteine:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Prophylactic NAC to Improve Platelet Engraftment After Haploidentical Transplantation in Severe Aplastic Anemia Patients Peking University People's Hospital NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE3
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis Tanta University NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
N-Acetylcysteine in Patients With Leptospirosis Dr Cipto Mangunkusumo General Hospital NA COMPLETED
(Sep 1, 2026)
PHASE2
Use of N-Acetylcysteine in the Treatment of Repetitive and Self-Injurious Behaviors in Cornelia de Lange Syndrome Johns Hopkins University NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease David Palma NA RECRUITING
(Aug 1, 2026)
PHASE2
Combined Antioxidant Therapy for Acute Myocardial Infarction University of Chile NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE2
Clinical Study Evaluating Efficacy, Safety and Molecular Mechanism of N-acetylcysteine Supplementation in Patients With Hepatic and Post Hepatic Jaundice Tanta University NA COMPLETED
(Jul 1, 2026)
PHASE2
An Open-Label, Bayesian Adaptive Phase II Clinical Study in HR+/HER2- Advanced Breast Cancer After Progression on Standard Therapy Fudan University NA RECRUITING
(Jul 1, 2026)
PHASE2
Study of the Efficacy of N-acetylcysteine (NAC) on Impulse Control Disorders Centre Hospitalier Universitaire, Amiens NA TERMINATED
(Jun 1, 2026)
PHASE3
Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Weill Medical College of Cornell University NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
24-Month Trial of NPI-001 for the Preservation of Photoreceptors in Retinitis Pigmentosa Associated With Usher Syndrome Nacuity Pharmaceuticals, Inc. NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE3
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Single-dose Stanford University NA RECRUITING
(May 1, 2026)
PHASE2
Antioxidant Therapy With N-acetylcysteine for Children With Neurofibromatosis Type 1 Children's Hospital Medical Center, Cincinnati NA COMPLETED
(May 1, 2026)
PHASE2
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Open Label Stanford University NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE2, PHASE3
Targeting the Neurobiology of RRB in Autism Using N-acetylcysteine: Trial Stanford University NA RECRUITING
(May 1, 2026)
PHASE2, PHASE3
PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis University Hospital, Lille NA RECRUITING
(May 1, 2026)
PHASE3
DMSO Dual-Route Therapy for Refractory Tinnitus in Long-COVID and Post-COVID-19 Vaccine Injury Leading Edge Clinic NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE2
PK and PD Study of NPI-001 and Cysteamine Bitartrate Nacuity Pharmaceuticals, Inc. NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Therapeutics for Moderate and Severe Dengue Oxford University Clinical Research Unit, Vietnam NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE3
Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD) Medical University of South Carolina NA COMPLETED
(Mar 1, 2026)
PHASE2
Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial Fernando J Martinez NA COMPLETED
(Mar 1, 2026)
PHASE3
An Optimal Dose Finding Study of N-Acetylcysteine in Patients With Myeloproliferative Neoplasms University of California, Irvine NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2
Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC) NYU Langone Health NA ACTIVE NOT RECRUITING
(Mar 1, 2026)


Acetylcysteine Generic API Manufacturers

Several generic applications have been filed for Acetylcysteine. The first generic version for Acetylcysteine was by Dey Lp and was approved on Oct 14, 1986. And the latest generic version is by Conba Usa Inc and was approved on Mar 14, 2025.

Given below is the list of companies who have filed for Acetylcysteine generic, along with the locations of their manufacturing plants worldwide.