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. Fourteen 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:	116
Clinical Trials:	14
Patent Applications:	4,337
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
Shandong Provincial Hospital	Phase 1
Central South University	Phase 1
University of Missouri-Columbia	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 and one FDA Regulatory Exclusivity.

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	8,399,445
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes	8,722,738
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes	9,327,028
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	AP	RX	Yes	Yes	8,653,061
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	8,148,356		Y

Expired US Patents for ACETADOTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	8,399,445
Cumberland Pharms	ACETADOTE	acetylcysteine	INJECTABLE;INTRAVENOUS	021539-001	Jan 23, 2004	8,653,061

International Patents for ACETADOTE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007024311
Malaysia	173215	ACETYLCYSTEINE COMPOSITIONS AND METHODS OF USE THEREOF
Hong Kong	1123972	乙酰半胱氨酸組合物及其用途 (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR)
Canada	2619441	COMPOSITION D'ACETYLCYSTEINE ET SES UTILISATIONS (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR)
New Zealand	566100	Acetylcysteine composition and uses therefor
Philippines	12012501687	ACETYLCYSTEINE COMPOSITION AND USES THEREFOR

Market Dynamics and Financial Trajectory for ACETADOTE

Last updated: July 28, 2025

Introduction

ACETADOTE (acetaminophen injection) is a therapeutic agent developed by Matawan, New Jersey-based Cumberland Pharmaceuticals. Approved by the U.S. Food and Drug Administration (FDA) in 2017, it is indicated for the treatment of acetaminophen overdose, a significant cause of acute liver failure globally. The drug’s market potential hinges on evolving clinical needs, regulatory pathways, competitive landscape, and healthcare policies. This analysis examines the current market dynamics and forecasts ACETADOTE's financial trajectory within the broader pharmaceutical industry.

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Market Landscape and Therapeutic Necessity

Acetaminophen overdose remains a prevalent concern in emergency medicine, with the CDC reporting over 50,000 cases annually in the U.S. alone [1]. Despite the widespread availability of oral acetaminophen, overdose incidents often result from accidental ingestion, misuse, or intentional overdose in suicide attempts. The primary antidote, N-acetylcysteine (NAC), is available both orally and intravenously; however, the injectable form—ACETADOTE—addresses critical gaps in situations where oral administration isn't feasible due to vomiting, altered mental status, or comatose states.

Significance of IV Acetadote in Clinical Settings:
ACETADOTE’s IV formulation offers rapid, reliable delivery of NAC, improving outcomes in acute liver failure cases. Its adoption is essential in emergency and intensive care units, where timely intervention can significantly reduce mortality. The increasing trend of hospital admissions for drug overdose positions the drug favorably in the emergency care market.

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Regulatory and Reimbursement Environment

FDA approval in 2017 marked ACETADOTE as a key player in overdose treatment. Since then, the drug has navigated a landscape influenced by policies promoting overdose management and increased funding for emergency care. Reimbursement policies, driven by CMS and private insurers, generally favor standard-of-care therapeutics with proven efficacy, ensuring stable revenue streams for authorized providers.

However, clarity around insurance coverage and differentiating the injectable form from oral NAC influence market penetration. CMS classifications of N-acetylcysteine as a medically necessary treatment support favorable reimbursement, though pricing negotiations remain critical.

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Market Penetration and Competitive Dynamics

Competitive landscape:
ACETADOTE faces competition from generic IV NAC formulations, primarily produced by multiple manufacturers licensed for the same indication. The generic market is well-established, often resulting in pricing pressures and limited margins for the branded product.

Key factors influencing market share include:

• Pricing strategies: The branded drug’s premium pricing compared to generics.
• Physician familiarity and trust: Established preferences for oral NAC due to low cost and efficacy.
• Hospital formularies: Institutional formulary decisions significantly impact product availability and preference.
• Awareness and education: Convincing emergency physicians and hospitals to prefer ACETADOTE over generics poses a challenge.

In recent years, efforts to differentiate ACETADOTE through clinical data, safety profile, and ease of administration have been central to expanding its presence.

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Market Penetration Challenges and Opportunities

Challenges:

• Price sensitivity: With generics dominating the market, price competition limits revenue growth.
• Limited brand differentiation: As a largely interchangeable product, ACETADOTE struggles to establish a dominant position solely based on clinical superiority.
• Hospital budgets: Cost containment pressures restrict adoption of higher-priced branded drugs.

Opportunities:

• Expanding indications: Potential off-label uses or new formulations could broaden the target population.
• Integration with drug overdose protocols: Strengthening partnerships with hospital systems and highlighting the drug's rapid infusion benefits can boost uptake.
• Market expansion beyond the U.S.: Emerging markets with high overdose rates present avenues for growth.

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Financial Trajectory and Forecasting

Revenue Drivers:

• Market share expansion: Growth depends on increased hospital adoption and formulary inclusion.
• Pricing strategies: Competitive pricing versus generics influences profitability margins.
• Volume growth: Rising overdose incidences and hospital admissions support increased demand.

Historical performance:
As a niche product, ACETADOTE’s initial sales have been modest but stable due to its specialized use. The company's quarterly reports indicate yearly revenue in the low millions, with room for growth depending on market expansion and strategic initiatives [2].

Forecasting trends (2023-2028):

• Moderate growth is projected, primarily driven by increased overdose cases and hospital adoption developments.
• Market penetration targets could augment revenues by 10-15% annually if strategic education and pricing efforts succeed.
• Competitive pressures and generic pricing could limit gross margins, necessitating cost optimization.

Potential catalysts include:

• Approval of new formulations or combination therapies.
• Policy shifts favoring emergent overdose treatments.
• Increasing public health initiatives emphasizing overdose prevention.

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Impacts of Healthcare Policies and Public Health Trends

Policy initiatives like the CDC’s overdose prevention programs and increased federal funding for mental health and substance use disorder treatment help elevate the profile of overdose antidotes. Additionally, hospital accreditation standards emphasizing prompt overdose management may further mandate the use of reliable IV NAC formulations, favoring ACETADOTE.

The opioid epidemic’s persistence continues to elevate demand for effective overdose treatments, potentially translating into sustained revenue streams for ACETADOTE, provided the company capitalizes on these trends through strategic marketing and hospital engagement.

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Conclusion

ACETADOTE occupies a critical niche within the overdose treatment landscape. Market dynamics are characterized by established generic competition, hospital formulary constraints, and pricing sensitivities. While growth prospects are moderate, opportunities persist through expanding overdose cases, policy support, and strategic positioning within emergency care protocols. The drug’s financial trajectory hinges on effective commercialization strategies, cost management, and ongoing healthcare trends emphasizing overdose intervention.

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Key Takeaways

• Persistent demand for IV NAC in emergency overdose management underpins ACETADOTE’s market presence.
• Generic competition exerts price pressures, necessitating strategic differentiation and negotiation.
• Hospital formulary inclusion and physician awareness are pivotal for broader adoption.
• Public health initiatives and rising overdose incidences offer growth opportunities amid a challenging competitive environment.
• Future success depends on cost-effective marketing, potential expansion into new indications, and international market entry.

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FAQs

1. How does ACETADOTE differ from oral NAC formulations?
ACETADOTE offers rapid intravenous delivery critical in cases where oral administration is not feasible, providing higher bioavailability and faster therapeutic response in emergency overdose scenarios.

2. What are the main challenges facing ACETADOTE’s market expansion?
Key challenges include competition from cheaper generics, hospital formulary restrictions, and physician preference for oral NAC, all of which limit market share growth.

3. Are there opportunities for ACETADOTE outside the United States?
Yes, markets with high overdose rates and limited access to specialized antidotes present opportunities for expansion, contingent on regulatory approval and price competitiveness.

4. How could healthcare policy changes influence ACETADOTE’s revenues?
Policymaker emphasis on overdose prevention and emergency care protocols could increase demand and facilitate formulary inclusion, positively impacting sales.

5. What is the potential for new indications of ACETADOTE?
While primarily indicated for overdose treatment, research into additional applications such as hepatoprotective effects may offer future therapeutic avenues, albeit with regulatory and clinical validation hurdles.

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Sources
[1] CDC, “Drug Overdose Deaths,” 2022.
[2] Cumberland Pharmaceuticals, quarterly financial reports, 2022.