Sodium thiosulfate - Generic Drug Details
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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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sodium thiosulfate has eighty-eight patent family members in twenty-seven countries.
There are two drug master file entries for sodium thiosulfate. Two suppliers are listed for this compound.
Summary for sodium thiosulfate
| International Patents: | 88 |
| US Patents: | 13 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 66 |
| Patent Applications: | 5,930 |
| 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 |
|---|---|
| City of Hope Medical Center | PHASE1 |
| National Cancer Institute (NCI) | PHASE1 |
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | PHASE2 |
Anatomical Therapeutic Chemical (ATC) Classes for sodium thiosulfate
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
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/005130Pedmarqsi 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 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for sodium thiosulfate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Singapore | 11202013220S | ANHYDROUS SODIUM THIOSULFATE AND FORMULATIONS THEREOF | ⤷ Get Started Free |
| Morocco | 53102 | FORMULATIONS DE THIOSULFATE DE SODIUM ANHYDRE | ⤷ Get Started Free |
| Japan | 7629976 | ⤷ Get Started Free | |
| Japan | 7408753 | ⤷ Get Started Free | |
| South Korea | 20250151582 | 무수 싸이오황산나트륨의 제형 (FORMULATIONS OF ANHYDROUS SODIUM THIOSULFATE) | ⤷ Get Started Free |
| Mexico | 2024003783 | FORMULACIONES DE TIOSULFATO DE SODIO ANHIDRO. (FORMULATIONS OF ANHYDROUS SODIUM THIOSULFATE.) | ⤷ Get Started Free |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sodium thiosulfate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1758590 | LUC00029 | Luxembourg | ⤷ Get Started Free | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
| 0145340 | 99C0005 | Belgium | ⤷ Get Started Free | PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204 |
| 0957929 | SPC/GB06/021 | United Kingdom | ⤷ Get Started Free | PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201 |
| 3141251 | 301099 | Netherlands | ⤷ Get Started Free | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, SODIUM SULPHATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE AND THE SECOND DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS POLYETHYLENE GLYCOL, ASCORBIC ACID, SODIUM ASCORBATE, SODIUM CHLORIDE AND POTASSIUM CHLORIDE; NATIONAL REGISTRATION NO/DATE: RVG 120195 20171114; FIRST REGISTRATION: IS IS/1/17/083/01 20171016 |
| 1948158 | 1690020-1 | Sweden | ⤷ Get Started Free | PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123 |
| 1856135 | SPC/GB20/016 | United Kingdom | ⤷ Get Started Free | 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; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Sodium Thiosulfate
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