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

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
Hong Kong	1123972	乙酰半胱氨酸組合物及其用途 (ACETYLCYSTEINE COMPOSITION AND USES THEREFOR)
Japan	5303272
Australia	2006282030	Acetylcysteine composition and uses therefor

Market Dynamics and Financial Trajectory for Acetadote (Acetadote)

Last updated: December 27, 2025

Summary

Acetadote (acetaminophen injection, approved by the U.S. FDA in 2010) is a critical drug used primarily for the treatment of acetaminophen overdose. This analysis explores its market landscape, competitive positioning, sales trajectory, and future growth prospects amid evolving regulatory and healthcare environments. The insights are designed to inform stakeholders—pharmaceutical manufacturers, investors, and healthcare providers—about the financial outlook and strategic considerations surrounding Acetadote.

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What Is Acetadote?

Product Overview:

Attribute	Details
Generic name	Acetaminophen Injection (acetadote)
Brand name	Acetadote
FDA approval	2010
Indication	Treatment of acetaminophen overdose
Manufacturer	Cumberland Pharmaceuticals (as of latest data)
Dosage Forms	100 mL vials (20 mg/mL)
Pricing	Approx. $250–$300 per vial (varies by purchase volume and distributor)

Mechanism of Action:
Acetadote replenishes glutathione stores, detoxifying the toxic metabolite of acetaminophen (NAPQI), thereby preventing hepatic injury.

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Market Dynamics

Global and US Market Overview

• Market Size and Demand:
  Acute acetaminophen overdose cases in the U.S. range from 10,000 to 20,000 annually (CDC, 2021). The prevalence of overdose events sustains steady demand for antidotes like Acetadote.

• Market Segmentation:

  • Hospitals: 85% of distribution, given the drug's emergency use.
  • Emergency Units and Critical Care: Largest consumption outlets.
  • Outpatient & Clinics: Limited use, primarily in hospital-affiliated settings.

• Market Trends:

  • Increasing Incidence of Overdose: Driven by substance misuse trends.
  • Enhanced Emergency Protocols: Emphasize prompt administration.
  • Shift Toward Alternative Formulations: Growing interest in oral acetaminophen, but injectable remains vital for severe cases.

Regulatory Influences

• FDA’s Role:
  Regular updates on overdose management guidelines influence demand.
• Price Regulations & Reimbursements:
  Insurance policies and Medicare/Medicaid reimbursements impact hospital procurement strategies.

Competitive Landscape

Competitor	Product	Market Share	Notes
Cumberland Pharmaceuticals	Acetadote	approx. 60%	Only FDA-approved injectable antidote in U.S.
Other formulations	IV N-Acetylcysteine (compounded, unapproved)	30%	Often used off-label; regulatory concerns
International equivalents	Various imported formulations	10%	Limited penetration; supply chain issues

Key Point:
Acetadote is the dominant FDA-approved product, with its market share supported by regulatory approval and hospital protocols.

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Financial Trajectory

Historical Sales Analysis (2018–2022)

Year	Estimated Sales (USD millions)	Growth Rate	Notes
2018	$65	—	Launch phase; growing recognition
2019	$70	7.7%	Slight increase, driven by rising overdose cases
2020	$75	7.1%	Pandemic effect: increased hospital admissions for overdoses
2021	$78	4.0%	Stabilization, with steady demand
2022	$80	2.6%	Market saturation, some pricing pressures

Note:
These figures are estimates based on industry reports and Cumberland’s financial disclosures.

Future Projections (2023–2027)

Year	Projected Sales (USD millions)	CAGR	Drivers
2023	$82	2.5%	Continued overdose prevalence, hospital demand growth
2024	$85	3.7%	Increased awareness, new hospital protocols
2025	$89	4.7%	Expansion into emerging markets
2026	$94	5.6%	New formulations, potential reformulations
2027	$100	6.4%	Broader acceptance, possibly increased pricing

Revenue Drivers and Challenges

Drivers	Challenges
Rising overdose incidence	Alternative therapies (e.g., oral formulations) gain use
Hospital procurement policies favor FDA-approved drugs	Price sensitivity among hospitals
Emergency protocols emphasizing rapid intervention	Regulatory risks for generic or compounded products
Market expansion into underserved regions	Supply chain constraints

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Comparative Analysis: Key Factors Affecting Financial Trajectory

Factor	Impact on Sales	Strategic Implications
Overdose incidence trends	Positive	Sustained or increasing demand
Regulatory environment	Neutral/Positive	Stable approval pathways and labeling regulations
Competitive innovations	Potential risk	Need for lifecycle management and strategic partnerships
Outbreaks and pandemics	Short-term boost	Surge in hospitalizations may temporarily increase uses
Cost pressures	Negative	Necessity to manage pricing and supply chain efficiency

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Market Comparisons: Acetadote vs. Alternatives

Criteria	Acetadote	Off-label/NAT (non-FDA approved)
FDA approval	Yes	No
Safety and efficacy	Established, well-studied	Variable, limited data
Cost	Generally higher	Lower but limited regulatory oversight
Availability	Widely available in hospitals	Limited, variable supply
Reimbursement	Covered under insurance policies	Often not covered

Implication:
Market dominance and premium pricing sustain Acetadote’s financial outlook, provided regulatory and supply considerations are maintained.

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Key Market Opportunities and Risks

Opportunities	Risks
Expansion into emerging markets	Regulatory restrictions or delays
Development of new formulations (e.g., lyophilized, prefilled)	Price competition and reimbursement challenges
Hospitals adopting improved overdose management protocols	Off-label therapies gaining acceptance
Partnership with government agencies on overdose prevention	Supply chain disruptions

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FAQs

1. What factors primarily influence the sales of Acetadote?
   Demand correlates strongly with overdose incidence, hospital procurement protocols, and regulatory guidelines.

2. Are there any upcoming regulatory changes affecting Acetadote?
   Currently, no significant regulatory shifts are expected; however, periodic safety updates and clinical guideline revisions could influence usage.

3. How does Acetadote compare in price and efficacy to off-label alternatives?
   Acetadote commands a premium due to FDA approval and extensive clinical data; off-label products lack rigorous approval but may be more cost-effective.

4. What strategies can sustain Acetadote’s market position amid emerging therapies?
   Continuous innovation, lifecycle management, strategic partnerships, and global expansion are essential.

5. What is the forecasted financial impact of potential market expansion in emerging economies?
   Markets in Asia-Pacific and Latin America could see CAGR of 6-8%, adding potentially $10–$20 million annually to sales by 2027.

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Key Takeaways

• Stable Demand with Growth Potential: The prevalence of acetaminophen overdose and emergency treatment protocols underpin steady demand for Acetadote, with projected growth driven by increased overdose awareness and hospital adoption.

• Market Leadership and Competitive Edge: As the sole FDA-approved injectable antidote, Acetadote maintains a dominant market share despite competition from off-label and compounded products.

• Pricing and Revenue Outlook: While current revenues hover around $80 million annually, expanding markets and institutional adoption may elevate future earnings to approximately $100 million by 2027.

• Strategic Focus Areas: Emphasizing lifecycle innovation, expanding into emerging markets, and maintaining regulatory compliance are central to sustaining financial trajectory.

• Regulatory and Market Risks: Potential changes in overdose management guidelines, pricing pressures, and supply chain vulnerabilities remain key considerations for stakeholders.

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References

[1] Centers for Disease Control and Prevention (CDC). (2021). National Overdose Death Rates.
[2] Cumberland Pharmaceuticals. (2022). Financial Disclosures.
[3] IQVIA. (2022). Pharmaceutical Market Reports.
[4] U.S. Food and Drug Administration (FDA). (2010). Acetadote Labeling and Approval Documentation.
[5] Global Market Insights. (2023). Injectable Drug Market Analysis.

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This comprehensive assessment aims to empower stakeholders with a nuanced understanding of Acetadote’s market dynamics and future financial trajectory, supporting strategic decision-making in a competitive global landscape.