Acetylcysteine - Generic Drug Details

What are the generic sources for acetylcysteine and what is the scope of freedom to operate?

Acetylcysteine is the generic ingredient in eight branded drugs marketed by Cumberland Pharms, Eugia Pharma, Exela Pharma, Fresenius Kabi Usa, Glenmark Pharms Inc, Indoco, Rising, Sagent Pharms Inc, Somerset Theraps Llc, Steriscience Speclts, Zydus Pharms, Alvogen, Am Regent, Hospira, Roxane, Apothecon, DEY, Arbor Pharms Llc, Galephar, and Mead Johnson, and is included in thirty NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Acetylcysteine has nineteen patent family members in eleven countries.

There are three drug master file entries for acetylcysteine. Seventeen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for acetylcysteine

International Patents:	19
US Patents:	8
Tradenames:	8
Applicants:	20
NDAs:	30
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	400
Patent Applications:	7,266
Drug Prices:	Drug price trends for acetylcysteine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acetylcysteine
What excipients (inactive ingredients) are in acetylcysteine?	acetylcysteine excipients list
DailyMed Link:	acetylcysteine at DailyMed

See drug prices for acetylcysteine

Recent Clinical Trials for acetylcysteine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Navamindradhiraj University	Phase 3
Xi'an International Medical Center Hospital	N/A
Air Force 986 Hospital	N/A

See all acetylcysteine clinical trials

Generic filers with tentative approvals for ACETYLCYSTEINE

Applicant	Application No.	Strength	Dosage Form
		6GM/30ML (200MG/ML)	INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for acetylcysteine

Drug Class	Antidote Antidote for Acetaminophen Overdose Mucolytic
Mechanism of Action	Reduction Activity
Physiological Effect	Decreased Respiratory Secretion Viscosity Increased Glutathione Concentration

Medical Subject Heading (MeSH) Categories for acetylcysteine

Antiviral Agents

Expectorants

Free Radical Scavengers

Anatomical Therapeutic Chemical (ATC) Classes for acetylcysteine

R05CB	Mucolytics
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for ACETYLCYSTEINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACETADOTE	Injection	acetylcysteine	200 mg/mL, 30 mL vials	021539	3	2012-04-04

US Patents and Regulatory Information for acetylcysteine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Indoco	ACETYLCYSTEINE	acetylcysteine	INJECTABLE;INTRAVENOUS	215620-001	Feb 23, 2022	AP	RX	No	No
Roxane	ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	072621-001	Sep 30, 1992		DISCN	No	No
Hospira	ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	071364-001	May 1, 1989		DISCN	No	No
Am Regent	ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	072489-001	Jul 28, 1995	AN	RX	No	Yes
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Fresenius Kabi Usa	ACETYLCYSTEINE	acetylcysteine	INJECTABLE;INTRAVENOUS	200644-001	Nov 7, 2012	AP	RX	No	No
Hospira	ACETYLCYSTEINE	acetylcysteine	SOLUTION;INHALATION, ORAL	074037-001	Aug 30, 1994	AN	RX	No	No

International Patents for acetylcysteine

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1123972	乙酰半胱氨酸組合物及其用途 (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR)
World Intellectual Property Organization (WIPO)	2012012640
World Intellectual Property Organization (WIPO)	2007024311
European Patent Office	1928449	COMPOSITION D'ACETYLCYSTEINE ET SES UTILISATIONS (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR)
Japan	2009506030
South Korea	20080047398	ACETYLCYSTEINE COMPOSITION AND USES THEREFOR
Australia	2006282030	Acetylcysteine composition and uses therefor

Acetylcysteine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Acetylcysteine

Market Size and Growth Projections

The global acetylcysteine market is poised for significant growth over the next decade. As of 2024, the market size is valued at approximately USD 2.1 billion, with projections indicating it will reach USD 10.1 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 19.5%[1][3][4].

Regional Analysis

North America

North America currently dominates the acetylcysteine market, accounting for the largest market share. This dominance is attributed to the high prevalence of respiratory conditions such as chronic obstructive pulmonary disease (COPD) and the widespread use of acetylcysteine for treating acetaminophen overdose. The U.S. market, in particular, is expected to grow from USD 480 million in 2023 to USD 4,100 million by 2034, at a CAGR of 21.6%[3].

Europe

Europe is another significant region, driven by the increasing prevalence of COPD and cystic fibrosis. The presence of renowned pharmaceutical companies and robust research institutions in Europe fosters innovation and adoption of advanced respiratory treatments, including acetylcysteine-based therapies[3][4].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing market, with a CAGR of 22.24% between 2023 and 2034. This growth is fueled by rising incidences of respiratory diseases, improved economic conditions, and expanding healthcare infrastructure[3][4].

Application Segments

Respiratory Diseases

Acetylcysteine is widely used in treating respiratory conditions such as COPD, bronchitis, and cystic fibrosis. Its mucolytic properties make it an effective agent for managing these conditions, contributing significantly to market growth[1][3][4].

Acetaminophen Overdose

The drug is also a critical antidote for acetaminophen overdose, available in both injectable and oral forms. The increasing cases of acetaminophen intoxication drive the demand for acetylcysteine, particularly in the form of NAC tablets[3].

Antioxidant Therapy and Other Applications

Beyond respiratory diseases and acetaminophen overdose, acetylcysteine is explored for its potential in antioxidant therapy, liver failure treatment, and cancer treatment. These emerging applications further diversify its market[3].

Dosage Forms

Tablets

Tablets are the most dominant form of acetylcysteine consumption, holding around 57% of the market share in 2023. The demand for NAC tablets is driven by their use in treating acetaminophen overdose and other respiratory conditions[3][4].

Inhalation Solution and Intravenous Form

Inhalation solutions and intravenous forms are also significant, particularly for respiratory conditions. Spray formulations, in particular, are gaining popularity due to their ease of use and improved drug delivery mechanisms[1][3].

Spray Segment

The spray segment is anticipated to witness rapid growth, with a CAGR of 21.25% during the forecast period. This is due to the convenience and efficacy of spray formulations in managing respiratory ailments such as COPD and cystic fibrosis[3].

Distribution Channels

The market is segmented by distribution channels including hospital pharmacies, retail pharmacies, online retail, and others. Hospital pharmacies and retail pharmacies remain the primary channels due to the prescription nature of the drug and the need for medical supervision[1].

Challenges and Restraints

High Cost of Treatment

One of the significant challenges facing the acetylcysteine market is the high cost of treatment. This includes not only the cost of the medication but also additional expenses such as medical consultations, diagnostic tests, and hospitalization. This financial burden can limit access to care, especially for underserved populations and those in low-resource settings[3].

Key Players and Competitive Landscape

The market is driven by key pharmaceutical players such as Zambon Group, Bristol Myers Squibb, Cipla Limited, Mylan N.V., Fresenius Kabi, and Biofac A/S (Sandoz). These companies are investing in research and development for improved formulations, optimizing supply chains, and increasing production capacities to meet the growing demand[1].

Market Trends and Insights

• Increasing Prevalence of Respiratory Conditions: The rising cases of COPD, cystic fibrosis, and other respiratory diseases are driving the demand for acetylcysteine.
• Advancements in Drug Delivery Systems: Improvements in spray technology and other drug delivery mechanisms are enhancing the efficacy and convenience of acetylcysteine treatments.
• Expanding Therapeutic Applications: Ongoing research is exploring new applications for acetylcysteine, including liver failure, cancer treatment, and antioxidant therapy[3][4].

Financial Trajectory

The financial trajectory of the acetylcysteine market is marked by robust growth. Here are some key financial projections:

• 2023 Market Size: USD 1.74 billion[3]
• 2024 Market Size: USD 2.11 billion[3]
• 2033 Market Size: USD 10.1 billion[1]
• CAGR: 19.5% to 21.4% depending on the source[1][3][4]

Key Takeaways

• The global acetylcysteine market is expected to grow significantly, driven by increasing demand for respiratory treatments and expanding therapeutic applications.
• North America and Europe are key regions, with Asia-Pacific expected to be the fastest-growing market.
• High costs of treatment pose a significant challenge, affecting access to care for underserved populations.
• Key pharmaceutical players are driving market growth through R&D and strategic initiatives.

FAQs

Q: What is the current market size of the global acetylcysteine market? A: As of 2024, the global acetylcysteine market size is valued at approximately USD 2.1 billion[1].

Q: What is the projected CAGR for the acetylcysteine market from 2024 to 2033? A: The market is expected to grow at a CAGR of 19.5% from 2024 to 2033[1].

Q: Which region is expected to be the fastest-growing market for acetylcysteine? A: The Asia-Pacific region is expected to be the fastest-growing market, with a CAGR of 22.24% between 2023 and 2034[3].

Q: What are the primary dosage forms of acetylcysteine? A: The primary dosage forms include tablets, inhalation solutions, and intravenous forms, with tablets holding the largest market share[1][3].

Q: What are the main challenges facing the acetylcysteine market? A: One of the significant challenges is the high cost of treatment, which can limit access to care for underserved populations and those in low-resource settings[3].

Sources

1. Custom Market Insights: Global Acetylcysteine Market Size, Trends, Share 2033[1].
2. PharmiWeb: N-Acetylcysteine Market Growth Forecast For 2033: Size And Share Insights[2].
3. Precedence Research: Acetylcysteine Market Size, Share, Demand | CAGR Of 21.4%[3].
4. Vantage Market Research: Acetylcysteine Market Size USD 2723.1 Million by 2032[4].