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Sodium nitrite; sodium thiosulfate - Generic Drug Details
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 thirty-nine patent family members in fourteen 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: | 39 |
| 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 |
|---|---|---|
| Japan | 6182622 | Start Trial |
| Japan | 2019048852 | Start Trial |
| Japan | 2016106110 | Start Trial |
| Portugal | 2451435 | 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 |
|---|---|---|---|---|
| 1758590 | LUC00029 | Luxembourg | Start Trial | PRODUCT NAME: SEL DE SODIUM D'ACIDE DEOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: IS/1/16/071/01 20170401 |
| 1259550 | 08C0052 | France | Start Trial | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
| 1912999 | 14C0076 | France | Start Trial | PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516 |
| 2203431 | 15C0013 | France | Start Trial | PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
