SODIUM THIOSULFATE Drug Patent Profile
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Which patents cover Sodium Thiosulfate, 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 three patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-four 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. One supplier is 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.
Summary for SODIUM THIOSULFATE
| International Patents: | 24 |
| US Patents: | 3 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 120 |
| Clinical Trials: | 57 |
| Patent Applications: | 2,217 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Hellenic Institute for the Study of Sepsis | Phase 2 |
| Sunnybrook Health Sciences Centre | Phase 2 |
| Byondis B.V. | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for SODIUM THIOSULFATE
Paragraph IV (Patent) Challenges for SODIUM THIOSULFATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| 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 three US patents.
Patents protecting SODIUM THIOSULFATE
Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| >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
See the table below for patents covering SODIUM THIOSULFATE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2020011992 | 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) | See Plans and Pricing |
| Japan | 2021107318 | チオ硫酸ナトリウムを含有する薬学的組成物 (PHARMACEUTICAL COMPOSITION CONTAINING SODIUM THIOSULFATE) | See Plans and Pricing |
| Japan | 6598965 | See Plans and Pricing | |
| Japan | 6182622 | See Plans and Pricing | |
| Japan | 6852136 | See Plans and Pricing | |
| Portugal | 2451435 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SODIUM THIOSULFATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1259550 | 08C0052 | France | See Plans and Pricing | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
| 1666481 | 17C1031 | France | See Plans and Pricing | PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324 |
| 2203431 | 2015/009 | Ireland | See Plans and Pricing | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115 |
| 2380576 | SPC/GB20/050 | United Kingdom | See Plans and Pricing | PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; REGISTERED: UK PL 45496/0009 20170526 |
| 2203431 | 92666 | Luxembourg | See Plans and Pricing | PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119 |
| 2822954 | 2018/031 | Ireland | See Plans and Pricing | 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 |
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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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