Sodium nitrite; sodium thiosulfate - Generic Drug Details

What are the generic sources for sodium nitrite; sodium thiosulfate and what is the scope of freedom to operate?

Sodium nitrite; sodium thiosulfate is the generic ingredient in one branded drug marketed by Hope Pharms and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium nitrite; sodium thiosulfate has fifty-six patent family members in fifteen countries.

One supplier is listed for this compound.

Summary for sodium nitrite; sodium thiosulfate

International Patents:	56
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	8
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sodium nitrite; sodium thiosulfate
DailyMed Link:	sodium nitrite; sodium thiosulfate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sodium nitrite; sodium thiosulfate

Constraining patent/regulatory exclusivity:

8,568,793

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.

Anatomical Therapeutic Chemical (ATC) Classes for sodium nitrite; sodium thiosulfate

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for sodium nitrite; sodium thiosulfate

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	10,479,686		Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	11,753,301		Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	9,345,724		Y	Y
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	9,585,912		Y	Y
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	8,568,793		Y	Y

International Patents for sodium nitrite; sodium thiosulfate

Country	Patent Number	Title	Estimated Expiration
Portugal	2395834
Slovenia	3569237
Japan	2019048852	チオ硫酸ナトリウムを含有する薬学的組成物 (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Poland	2451435
Hungary	E044781
Lithuania	3569237

Supplementary Protection Certificates for sodium nitrite; sodium thiosulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
0480717	98C0022	France		PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313
0579826	SPC/GB02/042	United Kingdom		PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826

Sodium nitrite; sodium thiosulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sodium Nitrite; Sodium Thiosulfate

Introduction

Sodium nitrite and sodium thiosulfate are chemical compounds with diverse applications, including medical treatments and industrial uses. When combined, they form a critical treatment for acute cyanide poisoning. Here, we will delve into the market dynamics and financial trajectory of this combination, particularly focusing on the drug NITHIODOTE, which contains both sodium nitrite and sodium thiosulfate.

Market Size and Growth

The market for sodium thiosulfate, a key component of the NITHIODOTE formulation, is expected to grow significantly. The sodium thiosulfate market is projected to reach USD 114.33 million in 2024 and is anticipated to grow at a CAGR of 5.55% to reach USD 149.79 million by 2029[1].

Key Applications

Medical Use

The combination of sodium nitrite and sodium thiosulfate is primarily used in medical settings for treating acute cyanide poisoning. This treatment works by sodium nitrite converting hemoglobin to methemoglobin, which binds to cyanide, and sodium thiosulfate providing a sulfur donor to convert cyanide to the less toxic thiocyanate[5].

NITHIODOTE

NITHIODOTE, marketed by Hope Pharms, is a notable drug that combines sodium nitrite and sodium thiosulfate. It is used intravenously and has been approved by the FDA for treating cyanide poisoning. The drug's unique market position and critical nature of the treatment it provides influence its financial trajectory[2].

Market Drivers

Increasing Demand in Medical Sector

The growing need for effective treatments in emergency medicine, particularly for cyanide poisoning, drives the demand for sodium nitrite and sodium thiosulfate. The approval of PEDMARK by the FDA, which is a sodium thiosulfate-based formulation, further highlights the increasing medical applications of these compounds[1].

Pharmaceutical Sector Growth

The pharmaceutical sector, especially in regions like India, is booming. India's role in manufacturing generic drugs, including those requiring sodium nitrite and sodium thiosulfate, contributes to the market growth[4].

Market Restraints

Side Effects and Toxicities

Concerns about the side effects of intravenous administration of sodium thiosulfate and the dose-limiting toxicities of sodium nitrite can hinder market growth. Alternative treatments, such as the hydroxocobalamin-thiosulfate combination, may offer more favorable risk-benefit profiles, potentially impacting the market share of sodium nitrite and sodium thiosulfate[5].

Regulatory and Patent Considerations

The market is also influenced by regulatory protections and patent expirations. For NITHIODOTE, the earliest date for generic entry is expected to be December 24, 2031, which could impact the financial trajectory of the drug once generic versions become available[2].

Regional Market Dynamics

Asia-Pacific Dominance

The Asia-Pacific region is expected to dominate the market for sodium thiosulfate, driven by increasing demand in countries like China, India, and Japan. This region's large population, growing disposable income, and increasing need for water treatment and pharmaceutical applications are key drivers[1].

Other Regions

Europe and North America also play significant roles, particularly in the pharmaceutical and food industries. However, the Asia-Pacific region's rapid growth and large market share make it the fastest-growing market for these compounds[4].

Financial Trajectory

Revenue Projections

The financial trajectory of NITHIODOTE and similar formulations is influenced by their unique market positions and the critical nature of the treatments they provide. With the sodium thiosulfate market expected to reach USD 149.79 million by 2029, the financial outlook is positive, despite potential challenges from generic entries and alternative treatments[1].

Investment and Funding

Companies like Fennec Pharmaceuticals Inc. have secured significant investments, such as the USD 5 million from Petrichor Healthcare Capital Management, which indicates strong financial backing for research and development in this area[1].

Key Players

Major Companies

Key players in the sodium thiosulfate market include INEOS, Liyang Qingfeng Fine chemical Co. Ltd, Changsha Weichuang Chemical Co. Ltd, Haimen Wuyang Chemical Industry Co. Ltd, and Nissei Corporation. For NITHIODOTE, Hope Pharms is the primary market player[1].

Conclusion

The market for sodium nitrite and sodium thiosulfate, particularly in the context of the drug NITHIODOTE, is driven by increasing medical and industrial demands. Despite challenges such as side effects and regulatory considerations, the financial trajectory remains positive due to the critical nature of the treatments and strong market growth in regions like the Asia-Pacific.

Key Takeaways

• The sodium thiosulfate market is expected to grow at a CAGR of 5.55% from 2024 to 2029.
• The Asia-Pacific region dominates the market due to high demand in water treatment and pharmaceutical sectors.
• NITHIODOTE, containing sodium nitrite and sodium thiosulfate, is a critical treatment for cyanide poisoning with a unique market position.
• Regulatory protections and patent expirations will impact the market in the future.
• Strong financial backing from investments supports research and development in this area.

FAQs

What is the primary use of the combination of sodium nitrite and sodium thiosulfate?

The primary use of the combination of sodium nitrite and sodium thiosulfate is for treating acute cyanide poisoning.

Which region is expected to dominate the sodium thiosulfate market?

The Asia-Pacific region is expected to dominate the sodium thiosulfate market due to high demand in countries like China, India, and Japan.

What are the potential restraints on the market growth of sodium nitrite and sodium thiosulfate?

Potential restraints include concerns about side effects, dose-limiting toxicities, and the availability of alternative treatments.

Who are the key players in the sodium thiosulfate market?

Key players include INEOS, Liyang Qingfeng Fine chemical Co. Ltd, Changsha Weichuang Chemical Co. Ltd, Haimen Wuyang Chemical Industry Co. Ltd, and Nissei Corporation.

When is the earliest date for generic entry of NITHIODOTE expected?

The earliest date for generic entry of NITHIODOTE is expected to be December 24, 2031.

Sources

1. Mordor Intelligence: Sodium Thiosulphate Market - Size, Share & Analysis
2. Drug Patent Watch: nithiodote Drug Patent Profile
3. Market Research Future: Sodium Nitrite Market Analysis
4. SNS Insider: Sodium Nitrite Market Size Share Industry Trends Forecast
5. CHEMM: Sodium Nitrite - Medical Countermeasures Database - CHEMM