Sodium thiosulfate - Generic Drug Details

What are the generic sources for sodium thiosulfate and what is the scope of patent protection?

Sodium thiosulfate is the generic ingredient in two branded drugs marketed by Us Army, Fennec Pharms Inc, and Hope Pharms, and is included in three NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium thiosulfate has sixty-eight patent family members in nineteen countries.

There are two drug master file entries for sodium thiosulfate. Two suppliers are listed for this compound.

Summary for sodium thiosulfate

International Patents:	68
US Patents:	12
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	133
Clinical Trials:	63
Patent Applications:	4,306
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
Air Force 986 Hospital	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes			Y
Hope Pharms	SODIUM THIOSULFATE	sodium thiosulfate	SOLUTION;INTRAVENOUS	203923-001	Feb 14, 2012		RX	Yes	Yes			Y	Y
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes			Y
Fennec Pharms Inc	PEDMARK	sodium thiosulfate	SOLUTION;INTRAVENOUS	212937-001	Sep 20, 2022		RX	Yes	Yes
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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2451435	COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Poland	2451435
Japan	2021504401	白金ベースの化学療法を受けている小児患者における聴覚毒性を低減するための方法
Portugal	2451435
Hungary	E035519
European Patent Office	3817751	FORMULATIONS DE THIOSULFATE DE SODIUM ANHYDRE (FORMULATIONS OF ANHYDROUS SODIUM THIOSULFATE)

Supplementary Protection Certificates for sodium thiosulfate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0290047	97C0108	Belgium		PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
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
2932970	1890039-9	Sweden		PRODUCT NAME: DOLUTEGRAVIR SODIUM + RILPIVIRINE HYDROCHLORIDE; REG. NO/DATE: EU/1/18/1282 20180518
1758590	LUC00029	Luxembourg		PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401
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
2380576	SPC/GB20/050	United Kingdom		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526

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

Last updated: 2024-12-17