Sodium thiosulfate - Generic Drug Details
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What are the generic drug 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-four 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: | 64 |
| 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 |
|---|---|
| Liga Panamericana de Asociaciones de Reumatologia (PANLAR) | Phase 1/Phase 2 |
| Pontificia Universidad Catolica de Chile | Phase 1/Phase 2 |
| Xianyang Central Hospital (the second people's Hospital of Xianyang City) | N/A |
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
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Fennec Pharms Inc | PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937-001 | Sep 20, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Fennec Pharms Inc | PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937-001 | Sep 20, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | |
| >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 |
|---|---|---|---|
| Australia | 2019299216 | Anhydrous sodium thiosulfate and formulations thereof | ⤷ Sign Up |
| Japan | 5905387 | ⤷ Sign Up | |
| Japan | 6598965 | ⤷ Sign Up | |
| Portugal | 2451435 | ⤷ Sign Up | |
| Australia | 2019299217 | Formulations of anhydrous sodium thiosulfate | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sodium thiosulfate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2563920 | CR 2019 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710 |
| 1713823 | 92595 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OU L UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, INCLUANT SIMEPREVIR SODIUM. FIRST REGISTRATION: 20140516 |
| 1912999 | 2014/058 | Ireland | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516 |
| 1758590 | LUC00029 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
| 2822954 | 2018/031 | Ireland | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTRATION NO/DATE: EU/1/18/1289 20180625 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
