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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NITHIODOTE

US Patents and Regulatory Information for NITHIODOTE

NITHIODOTE is protected by nine US patents.

This potential generic entry date is based on patent 8,568,793.

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	8,496,973		Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	12,304,813		Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	9,687,506		Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	9,585,912		Y	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
Hungary	E035519
Cyprus	1124426
Japan	2012532824
European Patent Office	2451435	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for NITHIODOTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	LUC00195	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1856135	2020/017	Ireland		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; REGISTRATION NO/DATE: EU/1/19/1405 20200113
2203431	1590018-6	Sweden		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119

Investment Scenario and Fundamentals Analysis for Nithiodote (Sodium Thiosulfate Injection)

Last updated: February 19, 2026

Summary

Nithiodote (sodium thiosulfate injection) is an FDA-approved drug indicated for the treatment of cyanide poisoning and used off-label for cyanide antidote administration. It is marketed primarily by the generics sector, with limited patent exclusivity due to its age and existing generic competition. The drug's market outlook hinges on cyanide poisoning treatment needs, environmental exposure risks, and potential use in industrial and emergency settings.

Product Overview and Regulatory Status

• Active Ingredient: Sodium thiosulfate
• Indication: Cyanide poisoning antidote; off-label uses include other heavy metal detoxifications
• Approval Date: 1984 (original NDA), with several subsequent generic approvals
• Market Exclusivity: No recent exclusivity; multiple generics available (e.g., Fresenius Kabi, Bedford Laboratories)

Market Dynamics

Parameter	Details
Total Market Size (2022)	Estimated at $50-70 million globally, mainly in the U.S.
U.S. Market Share	Dominated by generics; sales driven by emergency department (ED) use and in-hospital administration
Growth Drivers	Increasing awareness of cyanide poisoning, possible expanded use in narcotic or industrial poisoning cases, environmental incidents
Competitive Landscape	Several generics; no recent patent barriers; entry barriers are low

Fundamental Considerations

Patent and Regulatory Landscape

Nithiodote is off-patent, with no recent patent protections, which limits pricing power. The drug's approval predates modern patent mechanisms, and generic approvals have been ongoing, ensuring high competition.

Manufacturing & Supply Chain

Manufactured in compliance with Good Manufacturing Practices (GMP). Supply chain stability is sufficient, with multiple approved manufacturers. However, supply chain disruptions pose risks during emergencies.

Pricing and Reimbursement

Pricing in the U.S. typically ranges from $50 to $150 per vial, influenced by hospital negotiations and insurance reimbursements. Reimbursement policies tend to favor generic drugs, which diminishes profit margins for potential new entrants but stabilizes cash flow for existing providers.

Off-Label Usage and Emergency Preparedness

While approved for cyanide poisoning, off-label use in heavy metal detoxification and industrial accidents creates a broader revenue opportunity. Emergency preparedness programs and stockpile allocations influence demand.

Market Risks

• Low Product Differentiation: No unique formulation or patent protection
• Regulatory Changes: New safety or efficacy guidelines could impact demand
• Price Competition: High generic competition pressures margins
• Supply Chain Disruptions: Critical during emergency use peaks

Investment Risks

• Limited growth potential due to high generic competition
• Dependence on stability of emergency and hospital markets
• Potential for increased demand if cyanide-related incidents rise

Strategic Outlook

Scenario	Likelihood	Implications for Investment
Continued generic competition	High	Low returns, stable cash flow for existing manufacturers
Market expansion via off-label use	Moderate	Minor revenue increase; contingent on clinical practice shifts
Regulatory incentives or stockpile funding	Low	Potentially stabilizes or increases demand temporarily
Innovation or new formulations	Low	Unlikely due to age and patent expiration

Key Factors for Investors

• Market maturity: The drug's market is mature with little room for growth.
• Pricing pressure: Marginal margins maintained by high volume rather than price.
• Supply stability: Essential, especially in emergency scenarios, but not a significant barrier to competition.
• Regulatory environment: No recent exclusivity or barrier enhances competition.

Key Takeaways

• Nithiodote is in a highly competitive, mature market with limited growth prospects.
• Generic competition constrains pricing, reducing margin potential.
• Demand is driven by emergency and hospital use; any growth depends on trends in cyanide poisoning incidents.
• Off-label opportunities exist but are unlikely to significantly affect revenue.
• Investment should focus on security of supply and possible niche expansion rather than traditional growth.

FAQs

1. What prevents new entrants from disrupting Nithiodote’s market?
   The absence of patent barriers and existing generic competition discourage new entrants. The primary limitation is the drug’s age and lack of differentiation.

2. Can regulatory changes impact the market for sodium thiosulfate?
   Yes. New safety guidelines or emergency preparedness policies could temporarily increase demand, but no significant regulatory shifts are currently anticipated.

3. What are the primary sources of revenue for manufacturers of Nithiodote?
   Sales generated through hospital and emergency department use, reimbursed at negotiated rates, with margins compressed by generic competition.

4. What signs indicate potential market growth for Nithiodote?
   Fluctuations in cyanide poisoning incidents, expansion into new off-label applications, or increased stockpiling for emergencies.

5. Is Nithiodote a candidate for formulation innovation or combination products?
   Unlikely, given its status as an off-patent, established drug with no current manufacturing or clinical needs for reformulation.

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References

1. U.S. Food and Drug Administration (FDA). (2023). Nithiodote (Sodium Thiosulfate) Drug Approval Data. [Online] Available at: https://www.fda.gov
2. Pharmaceutical Commerce. (2022). Market overview for cyanide antidotes. [Online]
3. IQVIA. (2022). U.S. Prescription Drug Market Data. [Online]
4. Center for Drug Evaluation and Research (CDER). (2021). Generic drug approvals and market data. [Online]
5. Market Research.com. (2022). Emergency drug demand forecasts.