SODIUM THIOSULFATE - Generic Drug Details
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What are the generic drug sources for sodium thiosulfate and what is the scope of freedom to operate?
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 nine 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: | 9 |
| Tradenames: | 2 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 133 |
| Clinical Trials: | 60 |
| Patent Applications: | 4,306 |
| 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 |
|---|---|
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 2 |
| Yunnan Cancer Hospital | Phase 2 |
| Qilu Hospital of Shandong University | Phase 2 |
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
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Us Army | SODIUM THIOSULFATE | sodium thiosulfate | INJECTABLE;INJECTION | 020166-001 | Feb 14, 1992 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fennec Pharms Inc | PEDMARK | sodium thiosulfate | SOLUTION;INTRAVENOUS | 212937-001 | Sep 20, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Hope Pharms | SODIUM THIOSULFATE | sodium thiosulfate | SOLUTION;INTRAVENOUS | 203923-001 | Feb 14, 2012 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| >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 |
|---|---|---|---|
| Japan | 7166377 | ⤷ Try a Trial | |
| Japan | 6438071 | ⤷ Try a Trial | |
| Brazil | 112021000021 | tiossulfato de sódio anidro e formulações do mesmo | ⤷ Try a Trial |
| Morocco | 53102 | FORMULATIONS DE THIOSULFATE DE SODIUM ANHYDRE | ⤷ 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 |
|---|---|---|---|---|
| 2203431 | 2015/009 | Ireland | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115 |
| 1948158 | 16C0018 | France | ⤷ Try a Trial | PRODUCT NAME: SACUBITRIL/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'-(PENTANOY(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE)DE TRISODIUM HEMIPENTAHYDRATE; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
| 2666774 | CA 2020 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
