ACETADOTE Drug Patent Profile

Which patents cover Acetadote, and what generic alternatives are available?

Acetadote is a drug marketed by Cumberland Pharms and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has eighteen patent family members in eleven countries.

The generic ingredient in ACETADOTE is acetylcysteine. There are three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetylcysteine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acetadote

A generic version of ACETADOTE was approved as acetylcysteine by HOSPIRA on August 30^th, 1994.

Summary for ACETADOTE

International Patents:	18
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	14
Patent Applications:	2,031
Drug Prices:	Drug price information for ACETADOTE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACETADOTE
What excipients (inactive ingredients) are in ACETADOTE?	ACETADOTE excipients list
DailyMed Link:	ACETADOTE at DailyMed

See drug prices for ACETADOTE

Recent Clinical Trials for ACETADOTE

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

Sponsor	Phase
Central South University	Phase 1
University of Missouri-Columbia	Phase 1
Shandong Provincial Hospital	Phase 1

See all ACETADOTE clinical trials

Pharmacology for ACETADOTE

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

Paragraph IV (Patent) Challenges for ACETADOTE

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 ACETADOTE

ACETADOTE is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes

International Patents for ACETADOTE

See the table below for patents covering ACETADOTE around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	566100	Acetylcysteine composition and uses therefor
South Korea	20080047398	ACETYLCYSTEINE COMPOSITION AND USES THEREFOR
South Korea	101408336

ACETADOTE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acetylcysteine (ACETADOTE)

Introduction to Acetylcysteine (ACETADOTE)

Acetylcysteine, marketed under various trade names including ACETADOTE, is a versatile therapeutic agent widely used for its mucolytic properties and as an antidote for acetaminophen overdose. Here, we delve into the market dynamics and financial trajectory of acetylcysteine, highlighting its current status, growth drivers, and future prospects.

Global Market Size and Growth Rate

The global acetylcysteine market is experiencing robust growth, driven by increasing demand for respiratory treatments and antidotes for acetaminophen overdose. As of 2024, the global market size is estimated to be around USD 2.11 billion, with a projected growth to USD 14.69 billion by 2034 at a Compound Annual Growth Rate (CAGR) of 21.4%[1][3].

Regional Market Analysis

North America

North America dominates the acetylcysteine market, capturing the largest market share of 39% in 2023. The U.S. market, in particular, was valued at USD 480 million in 2023 and is expected to reach USD 4,100 million by 2034, growing at a CAGR of 21.6% from 2024 to 2034. This dominance is attributed to the high prevalence of respiratory conditions and the increasing cases of acetaminophen overdose in the region[1].

Europe

Europe is another significant market for acetylcysteine, driven by the rising incidence of chronic obstructive pulmonary disease (COPD) and cystic fibrosis. The region's robust pharmaceutical industry and research institutions contribute to the development and adoption of advanced respiratory treatments, including acetylcysteine-based therapies[1].

Asia Pacific

The Asia Pacific region is expected to expand at the fastest CAGR of 22.24% between 2023 and 2034. This growth is fueled by China's large manufacturing base and the increasing demand for healthcare services in the region[1].

Key Applications and Therapeutic Uses

Respiratory Conditions

Acetylcysteine is widely used in managing respiratory conditions such as COPD, bronchitis, and cystic fibrosis. Its mucolytic properties help in breaking down mucus, making it easier to expel, thus providing relief to patients with these conditions[1][3].

Acetaminophen Overdose

Acetylcysteine serves as a critical antidote for acetaminophen overdose, preventing liver damage. The rising cases of acetaminophen overdose globally have significantly driven the demand for acetylcysteine[1][3].

Expanding Therapeutic Applications

Ongoing clinical trials and research are exploring the potential applications of acetylcysteine in treating liver failure, cancer, and other medical conditions. This diversification of therapeutic uses is expected to unlock new market opportunities and drive further growth[1].

Market Segments and Growth Drivers

By Type

• Tablets: The tablets segment held the highest market share of 57% in 2023, driven by the increasing demand for N-Acetylcysteine (NAC) in treating acetaminophen intoxication and other healthcare applications[1].
• Spray: The spray segment is anticipated to witness rapid growth at a CAGR of 21.25%, due to its convenience and effectiveness in inhalation therapy for respiratory conditions[1].

By Application

• Pharmaceuticals: The primary application of acetylcysteine is in pharmaceuticals, where it is used as a mucolytic agent and an antidote for acetaminophen overdose.
• Dietary Supplements: Acetylcysteine is also used in dietary supplements, contributing to its growing market share.
• Personal Care: Its use in personal care products, though smaller, adds to the overall market growth[1].

Technological Advancements and Drug Delivery

Advancements in drug delivery technologies, particularly in inhalation solutions, have enhanced the effectiveness and ease of administering acetylcysteine. These innovations are a significant driver for the market, as they improve patient outcomes and compliance[1][3].

Financial Trajectory and Key Players

Revenue Growth

The acetylcysteine market is expected to see substantial revenue growth, driven by the expanding therapeutic applications and rising demand for respiratory treatments. Key pharmaceutical players such as Zambon Group, Bristol Myers Squibb, and Cipla Limited are investing heavily in research and development, supply chain optimizations, and increasing production capacities to meet the growing demand[1][3].

Strategic Initiatives and Partnerships

Strategic partnerships between pharmaceutical companies, academic institutions, and research organizations are facilitating the development of innovative formulations, dosage forms, and delivery systems. These collaborations are crucial for optimizing acetylcysteine's therapeutic potential and enhancing patient outcomes across a broader spectrum of diseases[1].

Challenges and Threats

Regulatory Challenges

Stringent regulatory requirements and evolving compliance standards pose a significant threat to the acetylcysteine market. Changes in regulations or delays in obtaining approvals for new formulations can impact product launches and market access[3].

Competitive Pressures

Intense competition among pharmaceutical companies may lead to price wars and profit margin pressures. Price erosion and aggressive marketing strategies by competitors can impact the overall revenue and market share of acetylcysteine products[3].

Supply Chain Disruptions

The acetylcysteine market is susceptible to disruptions in the global supply chain, affecting the availability of raw materials and finished products. Events such as natural disasters, geopolitical tensions, or pandemics can lead to shortages and increased production costs[3].

Key Takeaways

• The global acetylcysteine market is projected to grow significantly, driven by its applications in treating respiratory conditions and acetaminophen overdose.
• North America and Europe are key regions driving market growth, with Asia Pacific expected to grow at the fastest CAGR.
• Technological advancements in drug delivery and expanding therapeutic applications are major growth drivers.
• Key players are investing in R&D and strategic partnerships to enhance market presence and product offerings.
• Regulatory challenges, competitive pressures, and supply chain disruptions are significant threats to market growth.

FAQs

1. What is the current market size of the global acetylcysteine market? The global acetylcysteine market size was estimated at USD 2.11 billion in 2024[1].

2. What is the projected growth rate of the acetylcysteine market from 2024 to 2034? The acetylcysteine market is expected to grow at a CAGR of 21.4% from 2024 to 2034[1].

3. Which region dominates the acetylcysteine market? North America dominates the acetylcysteine market, capturing the largest market share of 39% in 2023[1].

4. What are the primary applications of acetylcysteine? The primary applications of acetylcysteine include treating respiratory conditions such as COPD and bronchitis, and serving as an antidote for acetaminophen overdose[1][3].

5. What are the major challenges facing the acetylcysteine market? The major challenges include regulatory challenges, competitive pressures, and supply chain disruptions[3].

Citations

[1] Precedence Research. Acetylcysteine Market Size, Share, Demand | CAGR Of 21.4%. Retrieved from https://www.precedenceresearch.com/acetylcysteine-market

[2] Cumberland Pharmaceutical. Cumberland Pharmaceutical Reports Double Digit Revenue Growth. Retrieved from https://investor.cumberlandpharma.com/news-releases/news-release-details/cumberland-pharmaceutical-reports-double-digit-revenue-growth

[3] Custom Market Insights. Global Acetylcysteine Market Size, Trends, Share 2033 - CMI. Retrieved from https://www.custommarketinsights.com/report/acetylcysteine-market/