NITHIODOTE Drug Patent Profile

Which patents cover Nithiodote, and when can generic versions of Nithiodote launch?

Nithiodote is a drug marketed by Hope Pharms and is included in one NDA. There are eight patents protecting this drug.

This drug has sixty-one patent family members in sixteen countries.

The generic ingredient in NITHIODOTE is sodium nitrite; sodium thiosulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite; sodium thiosulfate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nithiodote

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 24, 2031. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NITHIODOTE

International Patents:	61
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NITHIODOTE
What excipients (inactive ingredients) are in NITHIODOTE?	NITHIODOTE excipients list
DailyMed Link:	NITHIODOTE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NITHIODOTE

NDA:

201444

Dosage:

SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for NITHIODOTE

NITHIODOTE is protected by nine US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes			Y

International Patents for NITHIODOTE

When does loss-of-exclusivity occur for NITHIODOTE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Japan

Lithuania

Poland

Portugal

San Marino

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering NITHIODOTE around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3213756	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
European Patent Office	2395834	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU NITRITE DE SODIUM (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Japan	2021107318
Poland	2451435
Portugal	3569237
Japan	7408753
Hungary	E044781

Supplementary Protection Certificates for NITHIODOTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	CR 2019 00001	Denmark		PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522
0579826	02C0041	France		PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
1856135	CA 2020 00018	Denmark		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
1856135	CR 2020 00018	Denmark		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
1666481	17C1031	France		PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Nithiodote

Last updated: July 28, 2025

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Introduction

Nithiodote is an injectable pharmaceutical that combines sodium thiosulfate with doses of sodium thiosulfate and sodium nitrate, primarily used to treat cyanide poisoning. Its regulatory approval and clinical efficacy position it uniquely within the antidote market, characterized by increasing demand trends driven by global health trends, regulatory dynamics, and evolving treatment protocols. This analysis explores the market dynamics influencing Nithiodote’s positioning, alongside its projected financial trajectory amid industry shifts.

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Overview of Nithiodote: Pharmacology and Clinical Use

Nithiodote primarily functions as a cyanide antidote, offering rapid detoxification through its sulfur donor properties, facilitating cyanide detoxification via the cyanide-thiosulfate pathway. Its clinical applications extend to industrial accidents, fire-related poisonings, and certain medical emergencies. Approved by U.S.FDA, Nithiodote’s administration is recommended within hospital settings, emphasizing its role in emergency critical care.

Key Attributes of Nithiodote:

• Indication: Cyanide poisoning
• Delivery: Intravenous infusion
• Regulatory Status: Approved in the United States, with potential expansions in other markets

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Market Dynamics Influencing Nithiodote

Global Need for Cyanide Antidotes

The global industrial landscape, notably mining, metallurgy, and chemical manufacturing, significantly elevates cyanide poisoning risks. According to the World Health Organization (WHO), cyanide exposure incidents are on the rise, compounded by increased industrial activity in emerging economies. Furthermore, the threat of terrorism and accidental poisonings sustain the demand for effective antidotes.

Regulatory Environment and Market Access

Regulatory pathways heavily influence Nithiodote’s market penetration. The drug's FDA approval in 2014 facilitated initial coverage; however, expanding into international markets involves navigating complex approval processes, including the European Medicines Agency (EMA) and other regional agencies. The absence of an established antidote market monopoly encourages competitive entry but also necessitates robust regulatory and clinical evidence to sustain market share.

Healthcare Infrastructure and Emergency Preparedness

Hospitals, emergency response units, and military health systems constitute primary end-users. The preparedness of these entities to stock Nithiodote hinges on procurement budgets, training, and awareness. During periods of heightened emergency preparedness, demand surges—for instance, following industrial safety regulations tightening or public health crises involving toxic exposures.

Pricing Strategies and Reimbursement Policies

Pricing remains sensitive in emergency drug markets. Nithiodote’s pricing strategies, supported by insurance reimbursement policies and government-funded stockpiling programs, directly impact revenue flow. Medicaid, Medicare, and private insurers’ reimbursement standards influence operational profitability for manufacturers.

Competitive Landscape

Nithiodote competes with other cyanide antidotes such as the traditionally used hydroxocobalamin and cyanokit (prepared by CAI Pharmaceuticals). While Nithiodote offers rapid administration with tailored dosing, competition’s intensity depends on clinical efficacy, regulatory status, and supply chain robustness.

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Financial Trajectory Analysis

Revenue Streams and Growth Drivers

The revenue generated by Nithiodote is anticipated to grow steadily, considering:

• Market Penetration: Increased hospital adoption, especially in regions emphasizing industrial safety.
• Regulatory Expansion: Approval in additional territories broadens market access.
• Stockpiling and Emergency Use Agreements: Governments and military agencies routinely stockpile antidotes, leading to predictable revenue streams.

Growth Projections (2023-2030)

Based on available industry data and market size estimates:

• The global antidote market, including cyanide antidotes, was valued at approximately $150 million in 2022, projected to grow at a CAGR of 6-8% through 2030 (source: MarketsandMarkets).
• Nithiodote’s share, given FDA approval and focus on industrial safety markets, could see a compound annual growth rate (CAGR) of approximately 10-12%, driven by increased awareness and expansion into emerging markets.
• Stockpile procurement by the U.S. government and international agencies could contribute a significant portion of revenue, ensuring stability amid clinical or market fluctuations.

Cost Structures and Profit Margins

Production costs for Nithiodote include raw materials (sodium thiosulfate, sodium nitrate), manufacturing, and regulatory compliance. Although manufacturing costs are relatively moderate, high regulatory and quality assurance standards elevate expenses. With controlled supply and high clinical demand, profit margins are estimated at 25-30%, with room for improvement through scale efficiencies and regional market expansion.

Risks and Challenges

Potential barriers include:

• Regulatory delays in new markets
• Competition offering alternative antidotes
• Shifts in industrial safety regulations
• Supply chain disruptions affecting raw material availability
• Reimbursement policy changes impacting profitability

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Strategic Outlook and Opportunities

Innovation and Pipeline Development:
Investment in sharing clinical data and exploring new indications can foster market expansion. For example, research into broader emergency toxin management could position Nithiodote as a versatile antidote asset.

Global Market Expansion:
Targeted regulatory filings in Europe, Asia, and South America offer pathways to diversify revenue sources and hedge against regional market volatility.

Partnerships and Procurement Agreements:
Public-private partnerships with governments and WHO procurement initiatives further stabilize revenue streams and aid in global health initiatives.

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Conclusion

The market dynamics surrounding Nithiodote are shaped by increasing industrial exposure to cyanide, regulatory considerations, and emergency preparedness investments. Its financial trajectory indicates promising growth, anchored by global industrial safety needs and strategic regulatory expansion. Continuous innovation, strategic partnerships, and manufacturing scale will underpin sustainable long-term profitability.

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Key Takeaways

• Nithiodote stands to benefit from rising industrial risk, regulatory approvals, and emergency preparedness efforts.
• The antidote market's growth, projected at a CAGR of 6-8%, aligns favorably with Nithiodote’s expected expansion trajectory.
• Competitive positioning depends on clinical efficacy, regulatory access, and supply chain resilience.
• Revenue streams are bolstered by government procurement programs and hospital adoption, with potential for international diversification.
• Key risks include regulatory delays, competition, and supply chain vulnerabilities; proactive strategies are critical for sustained growth.

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FAQs

1. What distinguishes Nithiodote from other cyanide antidotes?
Nithiodote offers rapid intravenous administration with a favorable safety profile, leveraging its sulfur donor mechanism to detoxify cyanide efficiently. Its formulation allows for easy hospital use, contrasting with some alternatives requiring complex preparation.

2. Which markets are primary drivers for Nithiodote sales?
The United States remains the primary market due to established regulatory approval and industrial safety standards. Emerging markets in Asia and South America present growth opportunities driven by expanding industrial activity.

3. How does regulatory approval impact Nithiodote’s market expansion?
Regulatory approval in new regions reduces barriers to entry, encouraging local adoption. Streamlined approval processes or emergency use authorizations can significantly accelerate market penetration.

4. What are the main competitive threats to Nithiodote?
Competitors like hydroxocobalamin and cyanokit pose threats through established market presence and differing efficacy profiles. Price sensitivity and availability also influence competitive dynamics.

5. What strategies can enhance Nithiodote’s financial growth?
Investing in pipeline development, expanding global regulatory approval, forming strategic partnerships, and optimizing manufacturing scale will enhance growth prospects and financial performance.

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Sources:

[1] MarketsandMarkets, "Antidotes Market by Type and Region," 2022.
[2] U.S. Food and Drug Administration, "Nithiodote Approval Details," 2014.
[3] World Health Organization, "Industrial Cyanide Exposure Data," 2020.