sodium thiosulfate Drug Patent Profile

When do Sodium Thiosulfate patents expire, and what generic alternatives are available?

Sodium Thiosulfate is a drug marketed by Us Army and Hope Pharms and is included in two NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eleven countries.

The generic ingredient in SODIUM THIOSULFATE is sodium thiosulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sodium thiosulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sodium Thiosulfate

A generic version of sodium thiosulfate was approved as sodium thiosulfate by HOPE PHARMS on February 14^th, 2012.

Summary for sodium thiosulfate

International Patents:	28
US Patents:	5
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	63
Patent Applications:	2,959
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sodium thiosulfate
What excipients (inactive ingredients) are in sodium thiosulfate?	sodium thiosulfate excipients list
DailyMed Link:	sodium thiosulfate at DailyMed

Recent Clinical Trials for sodium thiosulfate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pontificia Universidad Catolica de Chile	Phase 1/Phase 2
Liga Panamericana de Asociaciones de Reumatologia (PANLAR)	Phase 1/Phase 2
The First Affiliated Hospital of ShiheziI University	N/A

See all sodium thiosulfate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for sodium thiosulfate

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

Paragraph IV (Patent) Challenges for SODIUM THIOSULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PEDMARK	Intravenous Injection	sodium thiosulfate	12.5 g/100 mL	212937	1	2022-10-18
PEDMARK	Intravenous Injection	sodium thiosulfate	12.5 g/100 mL	212937	1	2022-10-07
SODIUM THIOSULFATE	Intravenous Injection	sodium thiosulfate	12.5 g/50 mL	203923	1	2022-04-29

US Patents and Regulatory Information for sodium thiosulfate

sodium thiosulfate is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Us Army	SODIUM THIOSULFATE	sodium thiosulfate	INJECTABLE;INJECTION	020166-001	Feb 14, 1992		DISCN	Yes	No
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y	Y
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y	Y
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y	Y

EU/EMA Drug Approvals for sodium thiosulfate

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Fennec Pharmaceuticals (EU) Limited	Pedmarqsi	sodium thiosulfate	EMEA/H/C/005130 Pedmarqsi is indicated for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.	Authorised	no	no	no	2023-05-26

International Patents for sodium thiosulfate

See the table below for patents covering sodium thiosulfate around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2012532824
Portugal	2451435
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)
Hungary	E035519
Canada	2767168	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for 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
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
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
2673237	1990016-6	Sweden		PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REG. NO/DATE: EU/1/17/1173 20180326
2203431	CA 2015 00014	Denmark		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115

Sodium thiosulfate Market Analysis and Financial Projection Experimental

Sodium Thiosulfate Market Dynamics and Financial Trajectory

Introduction to Sodium Thiosulfate

Sodium thiosulfate is a versatile chemical compound with a wide range of applications, including medical, photographic processing, iodometry, gold extraction, and water treatment. Understanding its market dynamics and financial trajectory is crucial for investors, manufacturers, and end-users.

Market Size and Growth

The sodium thiosulfate market is projected to experience significant growth over the next few years. As of 2024, the market size is estimated to be USD 114.33 million and is expected to reach USD 149.79 million by 2029, growing at a Compound Annual Growth Rate (CAGR) of 5.55% during the forecast period[1][5].

Regional Market Analysis

Asia-Pacific Dominance

The Asia-Pacific region is the largest and fastest-growing market for sodium thiosulfate. This dominance is driven by high demand from the water treatment sector in countries such as China, India, Japan, and ASEAN. China, being the largest producer of gold globally, also contributes significantly to the demand for sodium thiosulfate in gold extraction[1][4].

North American Market

North America is anticipated to be one of the fastest-developing regions during the forecast period, primarily due to the growing demand for medical applications and pharmaceutical products. The U.S., with its substantial pharmaceutical industry, is a key driver of this growth[4].

Market Drivers

Growing Demand for Water Treatment

The increasing adoption of water treatment systems to avoid the spread of aquatic diseases is a significant driver for the sodium thiosulfate market. Sodium thiosulfate is used to decrease chlorine levels and treat settled backwash water in spas, swimming pools, and aquaria, making it an essential component in water treatment processes[4].

Medical Applications

The medical sector is another key driver, with sodium thiosulfate being used in various medical applications, including the treatment of cyanide poisoning and as a component in drugs like PEDMARK, which is used to prevent hearing loss in pediatric cancer patients. The approval of PEDMARK by the FDA in 2022 has further boosted the market[1][4].

Gold Extraction

Sodium thiosulfate's use in gold leaching processes is another significant driver. China's large gold production, accounting for around 9.3% of global production in 2021, contributes to the high demand for sodium thiosulfate in this sector[1].

Market Restraints

Side Effects and Health Concerns

Concerns about the side effects of intravenous administration of sodium thiosulfate are expected to hinder market growth. These side effects can be a deterrent for some medical applications, potentially limiting the market's expansion[1].

Volatility in Raw Material Prices

Volatility in the prices of raw materials used for the production of sodium thiosulfate can act as a market restraint. Fluctuations in raw material costs can impact the profitability and stability of sodium thiosulfate manufacturers[4].

Financial Trajectory

Capital Investments and Operating Expenses

Setting up a sodium thiosulfate manufacturing plant requires significant capital investments. The project economics include detailed analyses of capital expenditure (CapEx), operating expenditure (OpEx), income projections, taxation, depreciation, and liquidity analysis. Manufacturers need to consider fixed and variable costs, direct and indirect costs, and expected Return on Investment (ROI) and Net Present Value (NPV)[2].

Revenue Projections

The market is expected to generate substantial revenue, with the global sodium thiosulfate market valued at USD 96.36 million in 2021 and projected to reach USD 159.48 million by 2029, registering a CAGR of 6.50% during the forecast period[4].

Funding and Investment

Companies like Fennec Pharmaceuticals Inc. have secured significant investments, such as the USD 5 million senior secured promissory notes from Petrichor Healthcare Capital Management, which highlights the potential for financial growth and investment opportunities in the sodium thiosulfate market[1].

Regulatory and Approval Processes

The setup of a sodium thiosulfate manufacturing plant involves navigating through various regulatory procedures and obtaining necessary approvals. Manufacturers must comply with certifications and regulations to ensure the quality and safety of the product[2].

Key Players

The sodium thiosulfate market is dominated by several key players, including INEOS, Liyang Qingfeng Fine chemical Co. Ltd, Changsha Weichuang Chemical Co. Ltd., Haimen Wuyang Chemical Industry Co. Ltd., and Nissei Corporation. These companies play a crucial role in driving market growth through their production capacities and distribution networks[1].

Emerging Opportunities

Medical Industry

The emerging use of sodium thiosulfate in the medical industry is likely to create significant opportunities for market growth. New approvals and applications in the medical sector can expand the market's scope and demand[1].

Retail Expansion

Retailers hold prominent expansion avenues during the forecast period, particularly in regions with growing medical and healthcare sectors. This expansion can further increase business opportunities for sodium thiosulfate manufacturers and distributors[4].

Conclusion

The sodium thiosulfate market is poised for steady growth driven by its diverse applications, particularly in water treatment, medical, and gold extraction sectors. While it faces challenges such as side effects and raw material price volatility, the market's financial trajectory indicates promising revenue projections and investment opportunities.

Key Takeaways

• The sodium thiosulfate market is expected to grow from USD 114.33 million in 2024 to USD 149.79 million by 2029 at a CAGR of 5.55%.
• The Asia-Pacific region dominates the market due to high demand from water treatment and gold extraction.
• Medical applications, including the use in PEDMARK, are significant drivers.
• Volatility in raw material prices and side effects of intravenous administration are market restraints.
• Key players include INEOS, Liyang Qingfeng Fine chemical Co. Ltd, and others.
• Emerging opportunities lie in the medical industry and retail expansion.

FAQs

Q: What is the current market size of the sodium thiosulfate market?

The sodium thiosulfate market size is estimated to be USD 114.33 million in 2024[1].

Q: What is the expected CAGR of the sodium thiosulfate market from 2024 to 2029?

The sodium thiosulfate market is expected to grow at a CAGR of 5.55% from 2024 to 2029[1].

Q: Which region dominates the sodium thiosulfate market?

The Asia-Pacific region dominates the sodium thiosulfate market due to high demand from water treatment and gold extraction sectors[1][4].

Q: What are the major applications of sodium thiosulfate?

Major applications include water treatment, medical, photographic processing, iodometry, and gold extraction[1][4].

Q: 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[1].

Sources

1. Mordor Intelligence, Sodium Thiosulphate Market - Size, Share & Analysis, https://www.mordorintelligence.com/industry-reports/sodium-thiosulphate-market
2. IMARC Group, Sodium Thiosulfate Manufacturing Plant Project Report 2024: Industry Trends, Plant Setup, Machinery, Raw Materials, Investment Opportunities, Cost and Revenue, https://www.imarcgroup.com/sodium-thiosulfate-manufacturing-plant-project-report
3. Grand View Research, Sodium Thiosulphate Market Size, Share | Global Industry Report ..., https://www.grandviewresearch.com/industry-analysis/sodium-thiosulphate-market
4. Data Bridge Market Research, Sodium Thiosulphate Market Analysis & Growth, https://www.databridgemarketresearch.com/reports/global-sodium-thiosulphate-market
5. Mordor Intelligence, Sodium Thiosulphate Market Size | Mordor Intelligence, https://www.mordorintelligence.com/industry-reports/sodium-thiosulphate-market/market-size