sodium thiosulfate Drug Patent Profile
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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 14th, 2012.
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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: | 62 |
| Patent Applications: | 2,959 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Xianyang Central Hospital (the second people's Hospital of Xianyang City) | N/A |
| Ankang Central Hospital | N/A |
| Xi'an International Medical Center Hospital | 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 | 2022-10-07 |
| 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.
Patents protecting sodium thiosulfate
Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE SERIOUS OR LIFE-THREATENING
Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: SODIUM THIOSULFATE INJECTION IS INDICATED FOR SEQUENTIAL USE WITH SODIUM NITRITE FOR THE TREATMENT OF ACUTE CYANIDE POISONING
Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷ Sign Up
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| 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 | ⤷ 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 | ⤷ 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 | Y | ⤷ 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 | Y | ⤷ 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
See the table below for patents covering sodium thiosulfate around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 2451435 | ⤷ Sign Up | |
| Norway | 2451435 | ⤷ Sign Up | |
| European Patent Office | 3213756 | COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
| Japan | 2017165758 | 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) | ⤷ Sign Up |
| European Patent Office | 2451435 | COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS) | ⤷ Sign Up |
| Denmark | 2451435 | ⤷ Sign Up | |
| 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) | ⤷ 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 |
|---|---|---|---|---|
| 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 |
| 0788511 | SPC/GB08/036 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425 |
| 1499331 | SPC/GB13/034 | United Kingdom | ⤷ Sign Up | 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 |
| 1175904 | 2007C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| 2822954 | SPC/GB18/031 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625 |
| 2666774 | LUC00167 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217 |
| 1912999 | 1490062-5 | Sweden | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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