SODIUM NITRITE; SODIUM THIOSULFATE - Generic Drug Details
✉ Email this page to a colleague
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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sodium nitrite; sodium thiosulfate has fifty-five patent family members in fifteen countries.
One supplier is listed for this compound.
Summary for SODIUM NITRITE; SODIUM THIOSULFATE
| International Patents: | 55 |
| US Patents: | 7 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Patent Applications: | 8 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SODIUM NITRITE; SODIUM THIOSULFATE |
| DailyMed Link: | SODIUM NITRITE; SODIUM THIOSULFATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SODIUM NITRITE; SODIUM THIOSULFATE
Generic Entry Date for SODIUM NITRITE; SODIUM THIOSULFATE*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Hope Pharms | NITHIODOTE | sodium nitrite; sodium thiosulfate | SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | 201444-001 | Jan 14, 2011 | 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 |
International Patents for SODIUM NITRITE; SODIUM THIOSULFATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 2395834 | ⤷ Try a Trial | |
| Denmark | 3569237 | ⤷ Try a Trial | |
| Slovenia | 2395834 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2010093746 | ⤷ Try a Trial | |
| Japan | 2015199764 | 亜硝酸ナトリウムを含む医薬組成物 (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS) | ⤷ Try a Trial |
| Japan | 7408753 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SODIUM NITRITE; 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 |
| 1259550 | 08C0052 | France | ⤷ Try a Trial | PRODUCT NAME: SUGAMMADEX SODIUM; REGISTRATION NO/DATE: EU/1/08/466/001-002 20080725 |
| 0186405 | SPC/GB00/021 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316 |
| 1758590 | 2017C/063 | Belgium | ⤷ Try a Trial | PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612 |
| 1499331 | SPC/GB13/034 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313 |
| 0579826 | SPC/GB02/042 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ERTAPENEM ((1R,5S,6S,8R,2'S,4'S)-2-(2-(3-CARBOXYPHENYLCARBAMOYL)PYRROLIDIN-4-YLTHIO)-6-(1-HYDROXYETHYL)-1-METHYLCARBAPENEM-3-CARBOXYLIC ACID), A PHARMACEUTICALLY ACCEPTABLE SALT OR IN VIVO HYDROLYSABLE ESTER THEREOF, ESPECIALLY AS THE MONOSODIUM SALT ERTA; REGISTERED: UK EU/1/02/216/001 20020422 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
