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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 one branded drug marketed by Us Army and Hope Pharms, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sodium thiosulfate has twenty-two patent family members in eleven countries.
There are one thousand four hundred and seventy-two drug master file entries for sodium thiosulfate. One supplier is listed for this compound.
Summary for sodium thiosulfate
| International Patents: | 22 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 2 |
| NDAs: | 2 |
| Drug Master File Entries: | 1472 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 128 |
| Clinical Trials: | 50 |
| Patent Applications: | 2,217 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | sodium thiosulfate at DailyMed |
Recent Clinical Trials for sodium thiosulfate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hyunseok Kang, MD | Phase 2 |
| NRG Oncology | Phase 2 |
| Shanghai Children's Hospital | Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Us Army | SODIUM THIOSULFATE | sodium thiosulfate | INJECTABLE;INJECTION | 020166-001 | Feb 14, 1992 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for sodium thiosulfate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 6598965 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2011005841 | Start Trial |
| Japan | 2016106110 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sodium thiosulfate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203431 | 1590018-6 | Sweden | Start Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
| 1758590 | LUC00029 | Luxembourg | Start Trial | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
| 1874117 | 2014/032 | Ireland | Start Trial | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
