SODIUM THIOSULFATE Drug Patent Profile
✉ Email this page to a colleague
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 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.
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: | 60 |
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 |
---|---|
Yunnan Cancer Hospital | Phase 2 |
Qilu Hospital of Shandong University | Phase 2 |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | 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 |
---|---|---|---|---|---|---|
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: SODIUM THIOSULFATE INJECTION IS ADMINISTERED BY INTRAVENOUS INJECTION
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
Sodium thiosulfate-containing pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Canada | 2767168 | COMPOSITIONS PHARMACEUTIQUES CONTENANT DU THIOSULFATE DE SODIUM (SODIUM THIOSULFATE-CONTAINING PHARMACEUTICAL COMPOSITIONS) | ⤷ Try a Trial |
Denmark | 2451435 | ⤷ Try a Trial | |
Japan | 2012532824 | ⤷ Try a Trial | |
Japan | 7166377 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
Norway | 2451435 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SODIUM THIOSULFATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1713823 | 1490064-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
0473687 | SPC/GB98/030 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204 |
1856135 | 2090014-8 | Sweden | ⤷ Try a Trial | PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE OR SOLVATE OF FOSTAMATINIB OR THE PH ARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113 |
2203431 | CA 2015 00014 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150115 |
1948158 | 93075 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123 |
1948158 | 1690020-1 | Sweden | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |