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Sodium nitrite; sodium thiosulfate - Generic Drug Details
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What are the generic sources for sodium nitrite; sodium thiosulfate and what is the scope of freedom to operate?
Sodium nitrite; sodium thiosulfate
is the generic ingredient in one branded drug marketed by Hope Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sodium nitrite; sodium thiosulfate has twenty-nine patent family members in eleven countries.
There are one thousand four hundred and seventy-two drug master file entries for sodium nitrite; sodium thiosulfate. One supplier is listed for this compound.
Summary for sodium nitrite; sodium thiosulfate
| International Patents: | 29 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1472 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 1 |
| DailyMed Link: | sodium nitrite; sodium thiosulfate at DailyMed |
US Patents and Regulatory Information for sodium nitrite; 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 | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | 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 nitrite; sodium thiosulfate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| European Patent Office | 2451435 | Start Trial |
| Portugal | 2451435 | Start Trial |
| Japan | 2012517474 | Start Trial |
| Canada | 2752129 | Start Trial |
| European Patent Office | 3213756 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for sodium nitrite; sodium thiosulfate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0290047 | SPC/GB97/078 | United Kingdom | Start Trial | PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522 |
| 0579826 | 02C0041 | France | Start Trial | PRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418 |
| 1666481 | 17C1031 | France | Start Trial | 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 |
| 0788511 | SPC/GB08/036 | United Kingdom | Start Trial | 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 |
| 1912999 | 2014/058 | Ireland | Start Trial | PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REGISTRATION NO/DATE: EU/1/14/924/001-002 20140516 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
